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CompletedNCT02282007Updated Oct 6, 2022

Norwegian Psychomotor Physiotherapy - The Effect on Quality of Life

An interventional study of Individual NPMP to the participants in Pain, Stress and Psychosomatic Diseases, sponsored by Oslo Metropolitan University. Completed at 2 sites in Norway. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-06.

Sponsored by Oslo Metropolitan University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

More and more people suffer from stress-related illness and ailments that can greatly affect the individual's experienced quality of life and sense of coping since pain, physical, mental and social functioning are closely linked. Many of these people will seek primary care for help, and thus be referred to the Norwegian psychomotor physiotherapy (NPMP) performed by physiotherapists in primary care.

Data shows that for the first three months of 2009, 42% of patients were referred to NPMP had a musculoskeletal diagnosis as the first diagnosis, often in the form of long-term and comprehensive pain problems. Many of the patients also had emotional difficulties, but without being diagnosed with mental illness. 23% of patients who were referred to NPMP had a psychiatric diagnosis as the first diagnosis. The full range of psychiatric diagnoses are represented, but the majority of patients were treated for anxiety and depression.

The investigators want to let people who have had NPMP treatment to consider what effect the treatment has given, measured by separate registrations of quality of life, pain, physical, mental and social functioning.

Read the detailed description

The primary aim of this is project intends to evaluate the effect of Norwegian psychomotor physiotherapy (NPMP) on Health related Quality of Life measured by Short-form Health Survey (SF-36). The secondary aims are to evaluate the effect of Norwegian psychomotor physiotherapy (NPMP) on the variables Subjective Health Complaints Inventory (SHC); Hopkins 's Symptom Check List , Örebro Screening for musculo-skeletal pain ,Numeric Pain Rating Scale , Oslo Social Support Scale , Coping and The self-esteem scale"

The study design is based on the guidelines for randomized controlled trials presented in the CONSORT statement. The study will address to people who have had NPMP treatment approach, and they will be asked to consider what effect the treatment has given, measured by separate registrations of quality of life, pain, physical, mental and social functioning.

Participants Power calculation based on the primary outcome Short-form Health Survey (SF-36) proved that minimum 170 participants must be recruited. The participants will be recruited among patients on the waiting list for NPMP by all psychomotor physiotherapists who are members of the Norwegian Physiotherapists Association. If patients want to participate in the study, they will be randomized to an intervention group and a control group by drawing lots.

The intervention group will have NPMP as usual in 6 months. The control group remains on the waiting list for 6 months. Participants in both groups will be asked to fill out the self-assessment questionnaire at the start of the project and at the completion of the project after six months. Participants in the intervention group will receive the same form after 12 months, to examine whether there have been any subsequent change after completion NPMF.

Timing of surveys:

Participants will be given questionnaires by the NPMP physiotherapist at

  • Baseline - 2 weeks before NPMF (both groups)
  • After 6 months (both groups)
  • After 12 months (intervention group).
02

Conditions studied

  • Pain
  • Stress
  • Psychosomatic Diseases
  • Muscle Skeletal Disorders

Keywords

  • Quality of life
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Being referred to NPMP
  2. Being able to give informed consent
  3. The therapist finds the NPMP to be a proper treatment to this patient

Exclusion criteria

Exclusion Criteria:

  1. Do not understand Norwegian
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
105 participants (actual)

Study arms

  • No intervention
    No Intervention:Control group
  • Experimental
    Individual NPMP to the participants

    This arm will receive NPMP for 6 months, individually adjusted to their problems.

    Behavioral: Individual NPMP to the participants

Interventions

  • BehavioralIndividual NPMP to the participants

    The participants in the intervention group will receive NPMP individually adjusted for six months. NPMP is not a standardized treatment approach, but individually adjusted to the individual patient according to their individual problems.

05

What researchers measure

Primary outcomes

  1. Change from baseline in Short-form Health Survey (SF-36) at 6 months

    This will be assessed for both the control group and the intervention group.

    Time frame: 6 months

  2. Change from baseline in Short-form Health Survey (SF-36) at 12 months

    This outcome measure will be assessed only for the intervention group.

    Time frame: 12 months

Secondary outcomes

  1. Change from baseline in Subjective Health Complaints Inventory (SHC) at 6 months

    This will be assessed for both the control group and the intervention group.

    Time frame: 6 months

  2. Change from baseline in Subjective Health Complaints Inventory (SHC) at 12 months

    This outcome measure will be assessed only for the intervention group.

    Time frame: 12 months

  3. Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 6 months

    This will be assessed for both the control group and the intervention group.

    Time frame: 6 months

  4. Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 12 months

    This outcome measure will be assessed only for the intervention group.

    Time frame: 12 months

  5. Change from baseline in Örebro Screening for musculo-skeletal pain (Linton et al., 2011) at 6 months

    This outcome measure will be assessed both for the Control Group and for the intervention group.

    Time frame: 6 months

  6. Change from baseline in Örebro Screening for musculo-skeletal pain (Linton et al., 2011) at 12 months

    This outcome measure will be assessed only for the intervention group.

    Time frame: 12 months

Other outcomes

  1. Change from baseline in Numeric Pain Rating Scale (NPRS) at 6 months

    This outcome measure will be assessed both for the Control Group and for the intervention group.

    Time frame: 6 months

  2. Change from baseline in Numeric Pain Rating Scale (NPRS) at 12 months

    This outcome measure will be assessed only for the intervention group.

    Time frame: 12 months

  3. Change from Baseline in Oslo Social Support Scale (OSS-3) at 6 months

    This outcome measure will be assessed both for the Control Group and for the intervention group.

    Time frame: 6 months

  4. Change from Baseline in Oslo Social Support Scale (OSS-3) at 12 months

    This outcome measure will be assessed only for the intervention group.

    Time frame: 12 months

  5. Change from Baseline in Coping, (Pearlin & Schooler, 1978) at 6 months

    This outcome measure will be assessed both for the Control Group and for the intervention group.

    Time frame: 6 months

  6. Change from Baseline in Coping, (Pearlin & Schooler, 1978) at 12 months

    This outcome measure will be assessed only for the intervention group.

    Time frame: 12 months

  7. Change from Baseline in The self-esteem scale" (Rosenberg 1965) at 6 months

    This outcome measure will be assessed both for the Control Group and for the intervention group.

    Time frame: 6 months

  8. Change from Baseline in The self-esteem scale" (Rosenberg 1965) at 12 months

    This outcome measure will be assessed only for the intervention group.

    Time frame: 12 months

06

Study locations

2 sites
  • Oslo and Akershus University College of Applied Sciences
    Oslo, N130, Norway
  • HIOA
    Oslo, Norway
07

Registry details

Key details

Study ID
NCT02282007
Lead sponsor
Oslo Metropolitan University
Responsible party
Astrid Bergland (Professor, Oslo Metropolitan University) — Principal investigator
First posted
Nov 4, 2014
Start date
Feb 2014
Primary completion
Jul 2018
Completion
Jul 2018
Last update
Oct 6, 2022

Study contacts

Astrid Bergland, Phd
principal investigator · Oslo Metropolitan University

Oversight

Data monitoring committee
No
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