Physical DisabilityNPMPNCT02482792

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

A study testing Norwegian Psychomotor Physiotherapy and Cognitive Patient Education and PT in people with Physical Disability, run by Tove Dragesund at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 18 to 67 yearsHealthy volunteers can take part
Conditions the study is for: Physical Disability
What is being tested?: Norwegian Psychomotor Physiotherapy and Cognitive Patient Education and PT
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: 1 siteNorway
Study dates: Aug 2013to 26 Oct 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 67 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

Sick-listed > 6 months

Trial locations and contacts

1 site in 1 country.

Norway1 site

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

Other trials in Norway

About this study

Official title: Norwegian Psychomotor Physiotherapy Versus Cognitive Patient Education and Active Physiotherapy

Read the 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.

Conditions: Physical Disability
Being tested: Norwegian Psychomotor Physiotherapy, Cognitive Patient Education and PT
Keywords: Musculoskeletal disorders, Psychosomatic, Pain
Medical subject headings: Musculoskeletal Diseases, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Norwegian Psychomotor PhysiotherapyOther
Also called NPMP
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 PTOther
Also called COPE- PT
The comparison group will receive a combination of education about how to manage pain (COPE) followed by active individual physiotherapy.

Study groups in NCT02482792
Study group	Role	What they receive
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. Receives: 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). Receives: Other: Cognitive Patient Education and PT

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain
Pain on the Numeric Pain Rating Scale (NPRS)
Measured: 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
Wellbeing on the Short Form-12 Health Survey (SF-12)
Measured: 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
Sick-leave
Measured: 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
Function on the Shoulder Pain and Disability Inventory (SPADI)
Measured: 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
Function on the Norwegian Functional Assessment Scale (NFAS)
Measured: 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
Neck Disability Index (NDI)
Measured: 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
Global Body Examination-Flexibility (GBE)
Measured: Change from baseline flexibility at 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201326 Oct 2017

First posted26 Jun 2015 (estimated)
Study startAug 2013
Primary completion26 Oct 2017
Study completion26 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Physical DisabilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02482792
Sponsor's protocol ID: d7k8fj2m
Acronym: NPMP
Status last verified: Oct 2017
First submitted: 9 Jun 2015
Last updated: 27 Oct 2017
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

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.
PubMed 27496046

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Norwegian Psychomotor Physiotherapy Versus Cognitive Patient Education and Active Physiotherapy
ClinicalTrials.gov ID: NCT02482792
Acronym / sponsor ID: NPMP / d7k8fj2m
Conditions: Physical Disability
Keywords: Musculoskeletal disorders, Psychosomatic, Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: Tove DragesundUniversity, hospital or other
Collaborators: Norwegian Fund for Postgraduate Training in Physiotherapy
Study start: Aug 2013 (actual)
Primary completion: 26 Oct 2017 (actual)
Study completion: 26 Oct 2017 (actual)
First posted: 26 Jun 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Norwegian Psychomotor Physiotherapy	Experimental	Other: Norwegian Psychomotor PhysiotherapyNPMP 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.
Cognitive Patient Education and PT	Active comparator	Other: Cognitive Patient Education and PTThe 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).

Who may qualify

Ages: 18 to 67 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (1 listed)

Sick-listed > 6 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Norwegian Psychomotor PhysiotherapyAlso: NPMPThe 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	Norwegian Psychomotor Physiotherapy
Cognitive Patient Education and PTAlso: COPE- PTThe comparison group will receive a combination of education about how to manage pain (COPE) followed by active individual physiotherapy.	Other	Cognitive Patient Education and PT

Primary outcome

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)

6 secondary outcomes

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.
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.
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.
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.
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.
Efficacy of Norwegian Psychomotor Physiotherapy in Patients With Long-lasting pain
Time frame: Change from baseline flexibility at 6 months.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
Derived from this study: PubMed 27496046Dragesund 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alice Kvåle, PhD principal investigator

University of Bergen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Norwegian Psychomotor Physiotherapy and Cognitive Patient Education and PT in people with Physical Disability, run by Tove Dragesund at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02482792, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.