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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02482792
Other study ID # d7k8fj2m
Secondary ID
Status Completed
Phase N/A
First received June 9, 2015
Last updated October 26, 2017
Start date August 2013
Est. completion date October 26, 2017

Study information

Verified date October 2017
Source University of Bergen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date October 26, 2017
Est. primary completion date October 26, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 67 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
Norway Department of Global Public Health and Primary Care, UiB Bergen Hordaland

Sponsors (2)

Lead Sponsor Collaborator
Tove Dragesund Norwegian Fund for Postgraduate Training in Physiotherapy

Country where clinical trial is conducted

Norway, 

Outcome

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