NCT02482792

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

4.2 years

First QC Date

June 9, 2015

Last Update Submit

October 26, 2017

Conditions

Keywords

Musculoskeletal disordersPsychosomaticPain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain

    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

    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

    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

    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

    Change from baseline neck function at 3 months, at 6 months and 12 months.

  • +1 more secondary outcomes

Study Arms (2)

Norwegian Psychomotor Physiotherapy

EXPERIMENTAL

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

Cognitive Patient Education and PT

ACTIVE COMPARATOR

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

Interventions

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

Also known as: NPMP
Norwegian Psychomotor Physiotherapy

The comparison group will receive a combination of education about how to manage pain (COPE) followed by active individual physiotherapy.

Also known as: COPE- PT
Cognitive Patient Education and PT

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Sick-listed \> 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Global Public Health and Primary Care, UiB

Bergen, Hordaland, 5018, Norway

Location

Related Publications (1)

  • Dragesund T, Kvale A. Study protocol for Norwegian Psychomotor Physiotherapy versus Cognitive Patient Education in combination with active individualized physiotherapy in patients with long-lasting musculoskeletal pain - a randomized controlled trial. BMC Musculoskelet Disord. 2016 Aug 5;17:325. doi: 10.1186/s12891-016-1159-8.

MeSH Terms

Conditions

Musculoskeletal DiseasesPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alice Kvåle, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Post doc

Study Record Dates

First Submitted

June 9, 2015

First Posted

June 26, 2015

Study Start

August 1, 2013

Primary Completion

October 26, 2017

Study Completion

October 26, 2017

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations