ClinicalTrials.gg
CompletedNCT07322822Updated Apr 29, 2026

Active Coping Program for Chronic Musculoskeletal Pain: A Controlled Clinical Study

An interventional study of Active Coping Program and Usual Care in Chronic Musculoskeletal Pain and Chronic Pain, sponsored by Universidad de Extremadura. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Universidad de Extremadura · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
169
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 174 studies in Chronic Pain with a site in Spain — 34 open to participants now, 41 under way, 1 of them phase 3. Chronic Pain · Spain.

Enrollment
22nd of 141
169 · median 66
Started
2026
with 11 others
No phase
126 of 174
23 open now
Registered
155th of 174
by date

Among the 174 studies in Chronic Pain with a site in Spain, this one is the 22nd largest by enrollment of the 141 interventional ones, is one of 12 that started in 2026, is one of 126 with no phase, and was the 155th registered.

By phase

174 studies; the count open now beside each. This study's row is marked.

No phasethis study126 · 23 open
Observational33 · 10 open
Phase 38 · 1 open
Phase 43 · 0 open
Phase 22 · 0 open
Phase 11 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2003; this study’s year is marked. 12 started in 2026.

Size and results

Median enrollment 66 across the 141 interventional studies, 275 across the 33 observational. Of the 112 that completed or were terminated, 17 (15%) have results posted.

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02

Study summary

Chronic musculoskeletal pain is a highly prevalent condition that is often associated with persistent pain, physical disability, and maladaptive psychosocial factors such as pain catastrophizing, fear of movement, and central sensitization. These factors can contribute to pain persistence and reduced quality of life, highlighting the need for multimodal, non-pharmacological interventions that address both physical and psychological dimensions of pain.

The purpose of this study is to evaluate the effectiveness of an active coping program for patients with chronic musculoskeletal pain compared with usual care. The intervention is designed to promote active pain management strategies through education, movement-based exercises, and behavioral approaches aimed at improving pain coping, reducing disability, and addressing psychosocial contributors to chronic pain.

This is a controlled interventional study in which adult patients with chronic musculoskeletal pain will be allocated to either an intervention group receiving the active coping program or a control group receiving usual care. Outcome measures will be assessed at baseline and after completion of the intervention. Primary and secondary outcomes include pain-related disability, pain catastrophizing, fear of movement, symptoms of central sensitization, and health-related quality of life, measured using validated questionnaires.

The findings of this study are expected to provide evidence on the clinical effectiveness of an active coping approach in the management of chronic musculoskeletal pain and to support its implementation in routine clinical practice within primary care settings.

03

Conditions studied

  • Chronic Musculoskeletal Pain
  • Chronic Pain

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 years or older.
  • Diagnosis of chronic musculoskeletal pain, defined as pain persisting for more than 3 months.
  • Ability to understand study procedures and complete self-reported questionnaires.
  • Ability to participate in an active coping program involving education and movement-based activities.
  • Provision of written .

Exclusion criteria

Exclusion Criteria:

  • Presence of serious neurological, rheumatologic, or systemic disease that may interfere with participation in the intervention or outcome assessment.
  • Severe cognitive impairment or psychiatric condition that limits understanding of the study procedures.
  • Ongoing participation in another structured pain management or rehabilitation program.
  • Any medical condition that, in the opinion of the investigators, would make participation unsafe or compromise study results.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
169 participants (actual)

Study arms

  • Experimental
    Active Coping Program

    Behavioral: Active Coping Program

  • Active comparator
    Usual Care

    Other: Usual Care

Interventions

  • BehavioralActive Coping Program

    Participants assigned to this arm will receive an 8-week active coping program for chronic musculoskeletal pain. The program is a multimodal, non-pharmacological intervention aimed at improving self-management and active pain coping. Core components include pain education (e.g., understanding chronic pain mechanisms), movement-based therapeutic exercise/graded activity, and behavioral strategies to address maladaptive pain-related beliefs and behaviors (e.g., fear of movement and pain catastrophizing). The intervention is delivered following a standardized protocol to ensure consistency across participants.

  • OtherUsual Care

    Participants assigned to this arm will receive usual care as provided in routine clinical practice in primary care. No additional study-specific intervention is delivered. Usual care may include standard medical management, general advice and education, and referral to other services as clinically indicated, according to local practice.

06

What researchers measure

Primary outcomes

  1. Pain Catastrophizing Scale (PCS)

    The Pain Catastrophizing Scale (PCS) is a self-reported questionnaire assessing catastrophic thinking related to pain, including rumination, magnification, and helplessness. The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing (worse outcome).

    Time frame: Baseline (Week 0) and post-intervention (Week 8)

  2. Roland-Morris Disability Questionnaire (RMDQ)

    The Roland-Morris Disability Questionnaire (RMDQ) is a self-reported questionnaire assessing pain-related physical disability in daily activities. The total score ranges from 0 to 24, with higher scores indicating greater disability (worse outcome).

    Time frame: Baseline (Week 0) and post-intervention (Week 8)

  3. Tampa Scale for Kinesiophobia (TSK-11)

    The Tampa Scale for Kinesiophobia - 11 item version (TSK-11) is a self-reported questionnaire assessing fear of movement and re-injury related to pain. Total scores range from 11 to 44, with higher scores indicating greater kinesiophobia (worse outcome).

    Time frame: Baseline (Week 0) and post-intervention (Week 8)

  4. Central Sensitization Inventory (CSI)

    The Central Sensitization Inventory (CSI) is a self-reported questionnaire used to assess symptoms associated with central sensitization. The total score ranges from 0 to 100, with higher scores indicating greater symptom severity related to central sensitization (worse outcome).

    Time frame: Baseline (Week 0) and post-intervention (Week 8)

  5. 36-Item Short Form Health Survey (SF-36)

    The 36-Item Short Form Health Survey (SF-36) is a generic self-reported questionnaire assessing health-related quality of life across multiple physical and mental health domains. Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life (better outcome).

    Time frame: Baseline (Week 0) and post-intervention (Week 8)

07

Study locations

1 site
  • University of Extremadura
    Badajoz, Badajoz 06006, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2026 to primary completion in Apr 2026, 2 months.

Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 2 months is below that.

Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2025
First posted
Jan 7, 2026
StartActual
Feb 1, 2026
Primary completionActual
Apr 1, 2026
CompletionActual
Apr 1, 2026
Last update
Apr 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07322822
Lead sponsor
Universidad de Extremadura
Responsible party
Carlos Fernández-Morales (Clinical Professor, Universidad de Extremadura) — Principal investigator
First posted
Jan 7, 2026
Start date
Feb 1, 2026
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026
Last update
Apr 29, 2026

Study contacts

Luis Espejo-Antúnez, Ph.D.
study director · University of Extremadura

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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