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

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ClinicalTrials.gov Identifier: NCT02482792
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by (Responsible Party):
Tove Dragesund, University of Bergen

Brief 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

Condition or disease Intervention/treatment Phase
Physical Disability Other: Norwegian Psychomotor Physiotherapy Other: Cognitive Patient Education and PT Not Applicable

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  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Norwegian Psychomotor Physiotherapy Versus Cognitive Patient Education and Active Physiotherapy
Actual Study Start Date : August 2013
Actual Primary Completion Date : October 26, 2017
Actual Study Completion Date : October 26, 2017

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 Name: 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 Name: COPE- PT




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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)

  4. 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)

  5. 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)

  6. 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)



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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482792


Locations
Norway
Department of Global Public Health and Primary Care, UiB
Bergen, Hordaland, Norway, 5018
Sponsors and Collaborators
Tove Dragesund
Norwegian Fund for Postgraduate Training in Physiotherapy
Investigators
Principal Investigator: Alice Kvåle, PhD University of Bergen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tove Dragesund, Post doc, University of Bergen
ClinicalTrials.gov Identifier: NCT02482792     History of Changes
Other Study ID Numbers: d7k8fj2m
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Tove Dragesund, University of Bergen:
Musculoskeletal disorders
Psychosomatic
Pain

Additional relevant MeSH terms:
Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms