An observational study in Chronic Pain, Fibromyalgia and Chronic Fatigue Syndrome, sponsored by Pennine Acute Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Pennine Acute Hospitals NHS Trust · Observational
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Among 116 studies in Chronic Pain with a site in United Kingdom — 20 open to participants now, 22 under way, none of them phase 3. Chronic Pain · United Kingdom.
Among the 116 studies in Chronic Pain with a site in United Kingdom, this one is the 25th largest by enrollment of the 47 observational ones that give a count, is one of 8 that started in 2018, is one of 47 observational ones, and was the 46th registered.
3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.
Browse Chronic Pain studies →20 of the 116 studies in Chronic Pain with a site in United Kingdom are open now. Recruiting first, the newest first:
Cambridge University Hospitals NHS Foundation Trust · Sites in United Kingdom
Ages 18+
University of Oxford · Sites in United Kingdom
Ages 18+
VM Therapeutics LLC · Sites in United Kingdom
Ages 18–80
University of Nottingham · Sites in United Kingdom
Ages 40+ · Healthy volunteers
NHS Greater Glasgow and Clyde · Sites in United Kingdom
Ages 18–75
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
116 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 5 · Phase 3 9 · Phase 4 2
First in 2001; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 112 is close to the median of 120 across 753 observational studies indexed under Chronic Pain.
Median enrollment 60 across the 69 interventional studies, 132 across the 47 observational. Of the 72 that completed or were terminated, 17 (24%) have results posted.
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35 of 116 have an industry lead sponsor. The 10 most frequent:
Pennine Acute Hospitals NHS Trust is the lead sponsor of 4 studies on the registry; none are open to participants now.
Pennine Acute Hospitals NHS Trust has 1 study filed under Chronic Pain — fewer than ten, so there is no comparison to draw.
5 of the studies in Chronic Pain with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07096661Bournemouth UniversityPain Science Education for Labour and Postpartum Pain | 2026-12-01 |
| NCT06240299NHS Greater Glasgow and ClydeNeurofeedback for Nociplastic Pain in Rheumatoid Arthritis (NECTAR) | 2027-01-29 |
| NCT07698041Katherine FinlayRUTISS-Diary and RUTISS-65 Study | 2027-06-30 |
| NCT07072468VM Therapeutics LLCAnalgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN) | 2027-06-30 |
| NCT07237152University of NottinghamChronic Pain Predictors in Major Trauma | 2027-10 |
Add all 5 to your calendar (.ics) → With an account.
Among the 116 studies in Chronic Pain with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study explores whether it is feasible to use a newly developed activity pacing framework to standardise how activity pacing is instructed by healthcare professionals in rehabilitation programmes for patients with chronic pain/fatigue.
Activity pacing is frequently advised in the management of chronic pain/fatigue, including chronic low back pain, chronic widespread pain/fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis. However, there is no agreed definition of 'activity pacing' and it is instructed in various ways. For some, pacing involves adapting/limiting activities (for example, breaking down tasks/having rests); while for others, pacing involves having consistent activities/gradually increasing activities. Furthermore, pacing has been associated with both improved symptoms (decreased fatigue/anxiety/depression) and worsened symptoms (increased pain/disability).
Due to the high prevalence and cost (personal and financial) of chronic pain/fatigue, it is imperative that coping strategies such as pacing are clearly defined and evidence-based. This study involves Stage III in the development of an activity pacing framework to standardise how pacing is instructed by healthcare professionals. Stage I: Online Survey of pacing involved 92 healthcare professionals (doctors/nurses/physiotherapists/occupational therapists/clinical psychologists). The survey findings, together with existing research were used to develop the pacing framework. The framework was further developed in Stage II: Nominal Group Technique (consensus meeting), involving four patients and six healthcare professionals.
Stage III will test the feasibility of implementing the pacing framework clinically, by using it to underpin existing rehabilitation programmes for chronic pain/fatigue. Patients will attend rehabilitation programmes at the study sites as per usual practice. Patients' participation in this study involves their completion of a booklet of questionnaires. The aim of this feasibility study is to explore whether the activity pacing framework is usable in the clinical setting, to explore recruitment/retention rates, together with changes in symptoms between the start and end of treatment, and at 3-months follow-up. Stage III will also explore the acceptability of the framework by undertaking interviews with the patients and healthcare professionals involved in the rehabilitation programmes. Stage III is expected to last 22 months.
Future study will test the framework in a clinical trial to assess the effects of pacing on patients' symptoms. The pacing framework has the potential to improve treatments by providing guidance on the components of pacing found to have benefits for patients.
This study is funded by a Health Education England/National Institute for Health Research (HEE/NIHR) Integrated Clinical Academic (ICA) Clinical Lectureship.
The study population involves patients with conditions of chronic pain/fatigue, for example, chronic low back pain, chronic widespread pain, fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). The study population includes those patients who are referred to the physiotherapy departments of The Pennine Acute Hospitals National Health Service (NHS) Trust and who attend a rehabilitation programme. The activity pacing framework will be used to structure and standardise the pacing component of the programme.
Feasibility Study Inclusion Criteria:
Exclusion Criteria:
Acceptability Study (qualitative interviews) Inclusion Criteria:
Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.
Behavioral: Activity pacing framework
The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to assess the changes in activity pacing from baseline (pre-treatment: up to one week before the programme) to end of the programme (6-week's programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Time frame: Change in activity pacing from baseline (pre-treatment: up to one week before the programme) to the end of the 6-week's programme
Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28)
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at baseline (pre-treatment: up to one week before the programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Time frame: Baseline (pre-treatment: up to one week before the programme)
Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28)
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at the end of the 6-week's programme. Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Time frame: 6-weeks (end of the programme)
Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28)
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at 3-months follow up after the end of the 6-week's programme. Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Time frame: 3-months follow-up (after the end of the 6-week's programme)
Pain at Baseline: 11-point Numerical Rating Scale (NRS) of Pain
Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at baseline (pre-treatment: up to one week before the programme)
Time frame: Baseline (pre-treatment: up to one week before the programme)
Pain at the End of Treatment (6-weeks): 11-point Numerical Rating Scale (NRS) of Pain
Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at the end of the 6-week's programme.
Time frame: 6-weeks (end of the programme)
Pain at 3-months Follow up: 11-point Numerical Rating Scale (NRS) of Pain
Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at 3-months follow up after the end of the 6-week's programme
Time frame: 3-months follow-up (after the end of the 6-week's programme)
Depression at Baseline: Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.
Time frame: Baseline (pre-treatment: up to one week before the programme)
Depression at the End of Treatment (6-weeks): Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.
Time frame: 6-weeks (end of the programme)
Depression at 3-months Follow-up: Patient Health Questionnaire-9
The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.
Time frame: 3-months follow-up (after the end of the 6-week's programme)
Anxiety at Baseline: Generalised Anxiety Disorder Assessment (GAD-7)
The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.
Time frame: Baseline (pre-treatment: up to one week before the programme)
Anxiety at the End of Treatment (6-weeks): Generalised Anxiety Disorder Assessment (GAD-7)
The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.
Time frame: 6-weeks (end of the programme)
Anxiety at 3-months Follow up: Generalised Anxiety Disorder Assessment (GAD-7)
The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.
Time frame: 3-months follow-up (after the end of the 6-week's programme)
Self-efficacy at Baseline: Pain Self Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at baseline (pre-treatment: up to one week before the programme). The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.
Time frame: Baseline (pre-treatment: up to one week before the programme)
Self-efficacy at the End of Treatment: Pain Self Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.
Time frame: 6-weeks (end of the programme)
Self-efficacy at 3-months Follow up: Pain Self Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at 3-months follow up after the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.
Time frame: 3-months follow-up (after the end of the 6-week's programme)
Fatigue at Baseline: Chalder Fatigue Questionnaire (CFQ)
The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.
Time frame: Baseline (pre-treatment: up to one week before the programme)
Fatigue at the End of Treatment: Chalder Fatigue Questionnaire (CFQ)
The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.
Time frame: 6-weeks (end of the programme)
Fatigue at 3-months Follow up: Chalder Fatigue Questionnaire (CFQ)
The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.
Time frame: 3-months follow-up (after the end of the 6-week's programme)
Pain-related Anxiety, Fear and Avoidance at Baseline: Pain Anxiety Symptoms Scale-short Version (PASS-20)
The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at baseline (pre-treatment: up to one week before the programme). Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.
Time frame: Baseline (pre-treatment: up to one week before the programme)
Pain-related Anxiety, Fear and Avoidance at the End of Treatment: Pain Anxiety Symptoms Scale-short Version (PASS-20)
The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.
Time frame: 6-weeks (end of the programme)
Pain-related Anxiety, Fear and Avoidance at 3-months Follow up: Pain Anxiety Symptoms Scale-short Version (PASS-20)
The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at 3-months follow up after the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.
Time frame: 3-months follow-up (after the end of the 6-week's programme)
Physical and Mental Function at Baseline: 12-Item Short-Form Health Survey (SF-12)
The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at baseline (pre-treatment: up to one week before the programme). The two subscale scores have a maximum score of 100, where higher scores indicated better function.
Time frame: Baseline (pre-treatment: up to one week before the programme)
Physical and Mental Function at the End of Treatment: 12-Item Short-Form Health Survey (SF-12)
The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function.
Time frame: 6-weeks (end of the programme)
Physical and Mental Function at 3-months Follow up: 12-Item Short-Form Health Survey (SF-12)
The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at 3-months follow up after the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function.
Time frame: 3-months follow-up (after the end of the 6-week's programme)
General Health Status and Quality of Life at Baseline: EuroQol (EQ-5D-5L)
The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at baseline (pre-treatment: up to one week before the programme). The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.
Time frame: Baseline (pre-treatment: up to one week before the programme)
General Health Status and Quality of Life at the End of Treatment: EuroQol (EQ-5D-5L)
The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.
Time frame: 6-weeks (end of the programme)
General Health Status and Quality of Life at 3-months Follow up: EuroQol (EQ-5D-5L)
The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at 3-months follow up after the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.
Time frame: 3-months follow-up (after the end of the 6-week's programme)
For the feasibility study, patient recruitment occurred between 21st May 2018 and 3rd September 2019. Patients were recruited from those referred to a rehabilitation programme within a physiotherapy-led, out-patient service in a National Health Service (NHS) Trust in Northern England. The acceptability interviews involved patients (as above) and healthcare professionals (HCPs) delivering the programmes. HCP recruitment occurred between 18th September 2019 and 6th November 2019.
| Milestone | Activity Pacing Framework |
|---|---|
| Started | 112 |
| Completed | 57 |
| Not completed | 55 |
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to assess the changes in activity pacing from baseline (pre-treatment: up to one week before the programme) to end of the programme (6-week's programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
| score on a scale | Activity Pacing Framework |
|---|---|
| APQ-28 Activity adjustment | 0.70 (0.48 to 0.91) |
| APQ-28 Activity planning | 0.99 (0.72 to 1.26) |
| APQ-28 Activity consistency | 0.84 (0.60 to 1.07) |
| APQ-28 Activity acceptance | 0.67 (0.46 to 0.89) |
| APQ-28 Activity progression | 0.94 (0.65 to 1.22) |
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at baseline (pre-treatment: up to one week before the programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
| score on a scale | Activity Pacing Framework |
|---|---|
| APQ-28 Activity adjustment | 1.83 ± 0.81 |
| APQ-28 Activity planning | 1.49 ± 0.98 |
| APQ-28 Activity consistency | 1.85 ± 0.94 |
| APQ-28 Activity acceptance | 1.91 ± 0.92 |
| APQ-28 Activity progression | 1.51 ± 0.95 |
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at the end of the 6-week's programme. Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
| score on a scale | Activity Pacing Framework |
|---|---|
| APQ-28 Activity adjustment | 2.43 ± 0.73 |
| APQ-28 Activity planning | 2.42 ± 0.87 |
| APQ-28 Activity consistency | 2.65 ± 0.74 |
| APQ-28 Activity acceptance | 2.55 ± 0.72 |
| APQ-28 Activity progression | 2.39 ± 0.89 |
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to measure activity pacing at 3-months follow up after the end of the 6-week's programme. Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
| score on a scale | Activity Pacing Framework |
|---|---|
| APQ-28 Activity adjustment | 2.33 ± 0.90 |
| APQ-28 Activity planning | 2.06 ± 1.02 |
| APQ-28 Activity consistency | 2.37 ± 0.72 |
| APQ-28 Activity acceptance | 2.42 ± 0.95 |
| APQ-28 Activity progression | 2.00 ± 0.91 |
Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at baseline (pre-treatment: up to one week before the programme)
| score on a scale | Activity Pacing Framework |
|---|---|
| Current pain | 6.71 ± 1.96 |
| Usual pain | 7.47 ± 1.69 |
Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at the end of the 6-week's programme.
| score on a scale | Activity Pacing Framework |
|---|---|
| Current pain | 5.31 ± 2.38 |
| Usual pain | 6.62 ± 2.08 |
Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at 3-months follow up after the end of the 6-week's programme
| score on a scale | Activity Pacing Framework |
|---|---|
| Current pain | 5.65 ± 2.31 |
| Usual pain | 6.54 ± 1.93 |
The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.
| score on a scale | Activity Pacing Framework |
|---|---|
| Depression at Baseline: Patient Health Questionnaire-9 (PHQ-9) | 13.26 ± 6.86 |
The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.
| score on a scale | Activity Pacing Framework |
|---|---|
| Depression at the End of Treatment (6-weeks): Patient Health Questionnaire-9 (PHQ-9) | 7.14 ± 6.09 |
The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.
| score on a scale | Activity Pacing Framework |
|---|---|
| Depression at 3-months Follow-up: Patient Health Questionnaire-9 | 9.09 ± 5.76 |
The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.
| score on a scale | Activity Pacing Framework |
|---|---|
| Anxiety at Baseline: Generalised Anxiety Disorder Assessment (GAD-7) | 9.89 ± 5.92 |
The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.
| score on a scale | Activity Pacing Framework |
|---|---|
| Anxiety at the End of Treatment (6-weeks): Generalised Anxiety Disorder Assessment (GAD-7) | 5.40 ± 5.12 |
The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.
| score on a scale | Activity Pacing Framework |
|---|---|
| Anxiety at 3-months Follow up: Generalised Anxiety Disorder Assessment (GAD-7) | 6.10 ± 5.23 |
The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at baseline (pre-treatment: up to one week before the programme). The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.
| score on a scale | Activity Pacing Framework |
|---|---|
| Self-efficacy at Baseline: Pain Self Efficacy Questionnaire (PSEQ) | 25.67 ± 11.93 |
The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.
| score on a scale | Activity Pacing Framework |
|---|---|
| Self-efficacy at the End of Treatment: Pain Self Efficacy Questionnaire (PSEQ) | 36.29 ± 14.12 |
The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at 3-months follow up after the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.
| score on a scale | Activity Pacing Framework |
|---|---|
| Self-efficacy at 3-months Follow up: Pain Self Efficacy Questionnaire (PSEQ) | 34.68 ± 14.26 |
The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.
| score on a scale | Activity Pacing Framework |
|---|---|
| Physical fatigue | 14.81 ± 4.54 |
| Mental fatigue | 8.83 ± 2.94 |
The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.
| score on a scale | Activity Pacing Framework |
|---|---|
| Physical fatigue | 20.31 ± 3.92 |
| Mental fatigue | 11.28 ± 2.43 |
The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.
| score on a scale | Activity Pacing Framework |
|---|---|
| Physical fatigue | 18.18 ± 4.16 |
| Mental fatigue | 10.92 ± 2.34 |
The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at baseline (pre-treatment: up to one week before the programme). Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.
| score on a scale | Activity Pacing Framework |
|---|---|
| Pain-related Anxiety, Fear and Avoidance at Baseline: Pain Anxiety Symptoms Scale-short Version (PASS-20) | 13.14 ± 5.98 |
The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.
| score on a scale | Activity Pacing Framework |
|---|---|
| Pain-related Anxiety, Fear and Avoidance at the End of Treatment: Pain Anxiety Symptoms Scale-short Version (PASS-20) | 10.28 ± 5.89 |
The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at 3-months follow up after the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.
| score on a scale | Activity Pacing Framework |
|---|---|
| Pain-related Anxiety, Fear and Avoidance at 3-months Follow up: Pain Anxiety Symptoms Scale-short Version (PASS-20) | 12.12 ± 5.79 |
The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at baseline (pre-treatment: up to one week before the programme). The two subscale scores have a maximum score of 100, where higher scores indicated better function.
| score on a scale | Activity Pacing Framework |
|---|---|
| Physical function | 33.96 ± 8.82 |
| Mental function | 40.00 ± 11.36 |
The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function.
| score on a scale | Activity Pacing Framework |
|---|---|
| Physical function | 38.82 ± 9.06 |
| Mental function | 45.83 ± 11.48 |
The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at 3-months follow up after the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function.
| score on a scale | Activity Pacing Framework |
|---|---|
| Physical function | 36.55 ± 9.81 |
| Mental function | 44.56 ± 10.60 |
The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at baseline (pre-treatment: up to one week before the programme). The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.
| score on a scale | Activity Pacing Framework |
|---|---|
| General Health Status and Quality of Life at Baseline: EuroQol (EQ-5D-5L) | 0.42 ± 0.25 |
The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.
| score on a scale | Activity Pacing Framework |
|---|---|
| General Health Status and Quality of Life at the End of Treatment: EuroQol (EQ-5D-5L) | 0.56 ± 0.28 |
The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at 3-months follow up after the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.
| score on a scale | Activity Pacing Framework |
|---|---|
| General Health Status and Quality of Life at 3-months Follow up: EuroQol (EQ-5D-5L) | 0.52 ± 0.29 |
Collected over There were no adverse events throughout the duration of the study, that is, between the start of recruitment in May 2018 and the end of the 3-months follow-up data collection in December 2019.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Activity Pacing Framework | 0/107 (0%) | 0/107 (0%) | 0/107 (0%) |
All 107 participants were included in the baseline analyses. Some questions have fewer than 107 responses in instances of missing answers. For the question regarding participants' conditions, they were able to check more than one answer.
| Age, Continuous(years) | Activity Pacing Framework |
|---|---|
| Mean | 55.25 ± 12.83 |
| Sex: Female, Male(Participants) | Activity Pacing Framework |
|---|---|
| Female | 92 |
| Male | 15 |
| Race/Ethnicity, Customized(Participants) | Activity Pacing Framework |
|---|---|
| Ethnicity — White (British, Irish, Other) | 99 |
| Ethnicity — Black (Caribbean, African) | 1 |
| Ethnicity — Mixed (White/Black, White/Asian, other) | 3 |
| Ethnicity — Asian (Indian, Pakistani, Bangladeshi, other) | 3 |
| Ethnicity — Asian Eastern (Chinese, other) | 0 |
| Conditions(Participants) | Activity Pacing Framework |
|---|---|
| Low back pain | 79 |
| Chronic widespread pain | 52 |
| Fibromyalgia | 29 |
| Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) | 12 |
| Other (e.g. osteoarthritis) | 21 |
| Number of conditions(Participants) | Activity Pacing Framework |
|---|---|
| 1 condition | 41 |
| 2 conditions | 49 |
| 3 conditions | 12 |
| 4 conditions | 2 |
| 5 conditions | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Dec 2019, 19 months.
Results were first posted in Dec 2020, 11 months after primary completion.
Of 336 non-industry observational studies under Chronic Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's 19 months is below that.
Counting every sponsor, half of 362 studies reached it within 24 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Pennine Acute Hospitals NHS Trust