Norwegian Psychomotor Physiotherapy - The Effect on Quality of Life

October 5, 2022 updated by: Astrid Bergland, Oslo Metropolitan University

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

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

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

1. Do not understand Norwegian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Astrid Bergland, PhD, Oslo Metropolitan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 4, 2014

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

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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