Norwegian Psychomotor Physiotherapy in Patients With Long-lasting Musculoskeletal Pain. (NPMP)

October 26, 2017 updated by: Tove Dragesund

Norwegian Psychomotor Physiotherapy Versus Cognitive Patient Education and Active Physiotherapy

The aim is to examine the effect of Norwegian Psychomotor Physiotherapy (NPMP) in employees with long-lasting musculoskeletal pain compared to employees receiving Cognitive Patient Education in combination with active individual physiotherapy (COPE-PT) on pain, function, quality of life and sick-leave

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The NPMP is based on the assumption that patients with long-lasting problems, physical and/or psychological, may react with general aberrations related to posture, respiration, and movements, as well as with muscular tension and skin changes.

Employees With Long lasting musculoskeletal pain problems, working in the Municipality of Bergen, will be invited to participate in an Randomized Clinical Trial (RCT), and randomized to either receive Norwegian Psychomotor Physiotherapy (NPMP) or a series of Cognitive Patient Education in combination with active individual physiotherapy (COPE-PT). The aim is to examine the effect of NPMP compared to those receiving COPE-PT on pain, function, quality of life and sick-leave.

Study Type

Interventional

Enrollment (Actual)

128

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

  • Norway
    • Hordaland
      • Bergen, Hordaland, Norway, 5018
        • Department of Global Public Health and Primary Care, UiB

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

16 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients With neck,shoulder and/or widespread pain
  • Pain (≥ 3 Numeric Pain Rating Scale (NPRS)
  • Functional problems measured with Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ), Neck Disability Index (NDI) and/or Shoulder Pain and Disability Inventory (SPADI)-been sick-listed for 4-8 weeks, or on the brink of becoming sick-listed, or having had residual neck- and shoulder complaints problems during the last two years with several short-term sick-leaves.
  • =/6 American College of Rheumatology (ACR) tender points,
  • Reduced Relaxation and Flexibility from the Global Physiotherapy Examination (GPE)

Exclusion Criteria:

  • Sick-listed > 6 months

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
Experimental: Norwegian Psychomotor Physiotherapy
NPMP is a body-mind awareness approach, often given in a combination of massage, exercises and conversations. The NPMP is individualized, with duration of 45-60 minutes in each session. As the NPMP is a longitudinal and normally slow process to obtain change, treatment can last up till one year, in the beginning once a week, and after some time once a month.
Other: Norwegian Psychomotor Physiotherapy
The recruited patients will after randomization receive either Norwegian Psychomotor Physiotherapy (NPMP) or COPE combined with active individual physiotherapy. In NPMP the treatment is individualized, targeting body-mind awareness through exercise, massage and therapeutic conversation
Other Names:
  • NPMP
Active Comparator: Cognitive Patient Education and PT
The comparison group will receive a combination of education about how to manage pain (COPE) followed by active individual physiotherapy.They will receive one session weekly with COPE, given by a physiotherapist, maximum 4 times, followed by active individual Physiotherapy (PT).
Other: Cognitive Patient Education and PT
The comparison group will receive a combination of education about how to manage pain (COPE) followed by active individual physiotherapy.
Other Names:
  • COPE- PT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain
Time Frame: Change from baseline in pain at 3 months, at 6 months and 12 months.
Pain on the Numeric Pain Rating Scale (NPRS)
Change from baseline in pain at 3 months, at 6 months and 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain
Time Frame: Change from baseline in wellbeing at 3 months, at 6 months and 12 months.
Wellbeing on the Short Form-12 Health Survey (SF-12)
Change from baseline in wellbeing at 3 months, at 6 months and 12 months.
Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain
Time Frame: Change from baseline in sick-leave at 3 months, at 6 months and 12 months.
Sick-leave
Change from baseline in sick-leave at 3 months, at 6 months and 12 months.
Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain
Time Frame: Change from baseline in shoulder function at 3 months, at 6 months and 12 months.
Function on the Shoulder Pain and Disability Inventory (SPADI)
Change from baseline in shoulder function at 3 months, at 6 months and 12 months.
Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain
Time Frame: Change from baseline work related function at 3 months, at 6 months and 12 months.
Function on the Norwegian Functional Assessment Scale (NFAS)
Change from baseline work related function at 3 months, at 6 months and 12 months.
Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain
Time Frame: Change from baseline neck function at 3 months, at 6 months and 12 months.
Neck Disability Index (NDI)
Change from baseline neck function at 3 months, at 6 months and 12 months.
Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain
Time Frame: Change from baseline flexibility at 6 months.
Global Body Examination-Flexibility (GBE)
Change from baseline flexibility at 6 months.

Collaborators and Investigators

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

Sponsor

Tove Dragesund

Collaborators

Norwegian Fund for Postgraduate Training in Physiotherapy

Investigators

  • Principal Investigator: Alice Kvåle, PhD, University of Bergen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 1, 2013

Primary Completion (Actual)

October 26, 2017

Study Completion (Actual)

October 26, 2017

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 26, 2015

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • d7k8fj2m

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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