- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02282007
Norwegian Psychomotor Physiotherapy - The Effect on Quality of Life
Norwegian Psychomotor Physiotherapy - The Effect on Quality of Life, The Feeling of Pain, Coping, Physical, Psychological and Social Functioning After the Treatment
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.
Study Overview
Status
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway, N130
- Oslo and Akershus University College of Applied Sciences
-
Oslo, Norway
- HIOA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being referred to NPMP
- Being able to give informed consent
- The therapist finds the NPMP to be a proper treatment to this patient
Exclusion Criteria:
1. Do not understand Norwegian
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Short-form Health Survey (SF-36) at 6 months
Time Frame: 6 months
|
This will be assessed for both the control group and the intervention group.
|
6 months
|
Change from baseline in Short-form Health Survey (SF-36) at 12 months
Time Frame: 12 months
|
This outcome measure will be assessed only for the intervention group.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Subjective Health Complaints Inventory (SHC) at 6 months
Time Frame: 6 months
|
This will be assessed for both the control group and the intervention group.
|
6 months
|
Change from baseline in Subjective Health Complaints Inventory (SHC) at 12 months
Time Frame: 12 months
|
This outcome measure will be assessed only for the intervention group.
|
12 months
|
Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 6 months
Time Frame: 6 months
|
This will be assessed for both the control group and the intervention group.
|
6 months
|
Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 12 months
Time Frame: 12 months
|
This outcome measure will be assessed only for the intervention group.
|
12 months
|
Change from baseline in Örebro Screening for musculo-skeletal pain (Linton et al., 2011) at 6 months
Time Frame: 6 months
|
This outcome measure will be assessed both for the Control Group and for the intervention group.
|
6 months
|
Change from baseline in Örebro Screening for musculo-skeletal pain (Linton et al., 2011) at 12 months
Time Frame: 12 months
|
This outcome measure will be assessed only for the intervention group.
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Numeric Pain Rating Scale (NPRS) at 6 months
Time Frame: 6 months
|
This outcome measure will be assessed both for the Control Group and for the intervention group.
|
6 months
|
Change from baseline in Numeric Pain Rating Scale (NPRS) at 12 months
Time Frame: 12 months
|
This outcome measure will be assessed only for the intervention group.
|
12 months
|
Change from Baseline in Oslo Social Support Scale (OSS-3) at 6 months
Time Frame: 6 months
|
This outcome measure will be assessed both for the Control Group and for the intervention group.
|
6 months
|
Change from Baseline in Oslo Social Support Scale (OSS-3) at 12 months
Time Frame: 12 months
|
This outcome measure will be assessed only for the intervention group.
|
12 months
|
Change from Baseline in Coping, (Pearlin & Schooler, 1978) at 6 months
Time Frame: 6 months
|
This outcome measure will be assessed both for the Control Group and for the intervention group.
|
6 months
|
Change from Baseline in Coping, (Pearlin & Schooler, 1978) at 12 months
Time Frame: 12 months
|
This outcome measure will be assessed only for the intervention group.
|
12 months
|
Change from Baseline in The self-esteem scale" (Rosenberg 1965) at 6 months
Time Frame: 6 months
|
This outcome measure will be assessed both for the Control Group and for the intervention group.
|
6 months
|
Change from Baseline in The self-esteem scale" (Rosenberg 1965) at 12 months
Time Frame: 12 months
|
This outcome measure will be assessed only for the intervention group.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Astrid Bergland, PhD, Oslo Metropolitan University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REK 2013/1913
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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