PainNCT02282007
Norwegian Psychomotor Physiotherapy - The Effect on Quality of Life
A study testing Individual NPMP to the participants in people with Pain and Stress, run by Oslo Metropolitan University at 2 sites in Norway.
Trial summary
More and more people suffer from stress-related illness and ailments that can greatly affect the individual's experienced quality of life and sense of coping since pain, physical, mental and social functioning are closely linked. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Stress, Psychosomatic Diseases
- What is being tested?
- Individual NPMP to the participants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesNorway
- Study dates
- Feb 2014to Jul 2018
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being referred to NPMP
- Being able to give informed consent
- The therapist finds the NPMP to be a proper treatment to this patient
Who cannot join
- 1. Do not understand Norwegian
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo and Akershus University College of Applied Sciences
Oslo, N130
HIOA
Oslo
About this study
Official title: Norwegian Psychomotor Physiotherapy - The Effect on Quality of Life, The Feeling of Pain, Coping, Physical, Psychological and Social Functioning After the Treatment
More and more people suffer from stress-related illness and ailments that can greatly affect the individual's experienced quality of life and sense of coping since pain, physical, mental and social functioning are closely linked. Many of these people will seek primary care for help, and thus be referred to the Norwegian psychomotor physiotherapy (NPMP) performed by physiotherapists in primary care.
Data shows that for the first three months of 2009, 42% of patients were referred to NPMP had a musculoskeletal diagnosis as the first diagnosis, often in the form of long-term and comprehensive pain problems. Many of the patients also had emotional difficulties, but without being diagnosed with mental illness. 23% of patients who were referred to NPMP had a psychiatric diagnosis as the first diagnosis. The full range of psychiatric diagnoses are represented, but the majority of patients were treated for anxiety and depression.
The investigators want to let people who have had NPMP treatment to consider what effect the treatment has given, measured by separate registrations of quality of life, pain, physical, mental and social functioning.
Read the detailed description
The primary aim of this is project intends to evaluate the effect of Norwegian psychomotor physiotherapy (NPMP) on Health related Quality of Life measured by Short-form Health Survey (SF-36). The secondary aims are to evaluate the effect of Norwegian psychomotor physiotherapy (NPMP) on the variables Subjective Health Complaints Inventory (SHC); Hopkins 's Symptom Check List , Örebro Screening for musculo-skeletal pain ,Numeric Pain Rating Scale , Oslo Social Support Scale , Coping and The self-esteem scale"
The study design is based on the guidelines for randomized controlled trials presented in the CONSORT statement. The study will address to people who have had NPMP treatment approach, and they will be asked to consider what effect the treatment has given, measured by separate registrations of quality of life, pain, physical, mental and social functioning.
Participants Power calculation based on the primary outcome Short-form Health Survey (SF-36) proved that minimum 170 participants must be recruited. The participants will be recruited among patients on the waiting list for NPMP by all psychomotor physiotherapists who are members of the Norwegian Physiotherapists Association. If patients want to participate in the study, they will be randomized to an intervention group and a control group by drawing lots.
The intervention group will have NPMP as usual in 6 months. The control group remains on the waiting list for 6 months. Participants in both groups will be asked to fill out the self-assessment questionnaire at the start of the project and at the completion of the project after six months. Participants in the intervention group will receive the same form after 12 months, to examine whether there have been any subsequent change after completion NPMF.
Timing of surveys:
Participants will be given questionnaires by the NPMP physiotherapist at
- Baseline - 2 weeks before NPMF (both groups)
- After 6 months (both groups)
- After 12 months (intervention group).
- Conditions
- Pain, Stress, Psychosomatic Diseases, Muscle Skeletal Disorders
- Being tested
- Individual NPMP to the participants
- Keywords
- Quality of life
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual NPMP to the participantsBehavioural
The participants in the intervention group will receive NPMP individually adjusted for six months. NPMP is not a standardized treatment approach, but individually adjusted to the individual patient according to their individual problems.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention:Control group | No intervention | Not described |
| Individual NPMP to the participants | Experimental | This arm will receive NPMP for 6 months, individually adjusted to their problems. Receives: Behavioral: Individual NPMP to the participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Short-form Health Survey (SF-36) at 6 months
This will be assessed for both the control group and the intervention group.
Measured: 6 months
Change from baseline in Short-form Health Survey (SF-36) at 12 months
This outcome measure will be assessed only for the intervention group.
Measured: 12 months
Secondary outcomes (6)
Change from baseline in Subjective Health Complaints Inventory (SHC) at 6 months
This will be assessed for both the control group and the intervention group.
Measured: 6 months
Change from baseline in Subjective Health Complaints Inventory (SHC) at 12 months
This outcome measure will be assessed only for the intervention group.
Measured: 12 months
Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 6 months
This will be assessed for both the control group and the intervention group.
Measured: 6 months
Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 12 months
This outcome measure will be assessed only for the intervention group.
Measured: 12 months
Change from baseline in Örebro Screening for musculo-skeletal pain (Linton et al., 2011) at 6 months
This outcome measure will be assessed both for the Control Group and for the intervention group.
Measured: 6 months
Change from baseline in Örebro Screening for musculo-skeletal pain (Linton et al., 2011) at 12 months
This outcome measure will be assessed only for the intervention group.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Astrid Bergland, Oslo Metropolitan University
- Investigators
- Astrid Bergland, Phd, Principal investigator, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282007
- Sponsor's protocol ID
- REK 2013/1913
- Status last verified
- Oct 2022
- First submitted
- 17 Mar 2014
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwegian Psychomotor Physiotherapy - The Effect on Quality of Life, The Feeling of Pain, Coping, Physical, Psychological and Social Functioning After the Treatment
- ClinicalTrials.gov ID
- NCT02282007
- Acronym / sponsor ID
- REK 2013/1913
- Conditions
- Pain, Stress, Psychosomatic Diseases, Muscle Skeletal Disorders
- Keywords
- Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 4 Nov 2014 (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.
More and more people suffer from stress-related illness and ailments that can greatly affect the individual's experienced quality of life and sense of coping since pain, physical, mental and social functioning are closely linked. Many of these people will seek primary care for help, and thus be referred to the Norwegian psychomotor physiotherapy (NPMP) performed by physiotherapists in primary care.
Data shows that for the first three months of 2009, 42% of patients were referred to NPMP had a musculoskeletal diagnosis as the first diagnosis, often in the form of long-term and comprehensive pain problems. Many of the patients also had emotional difficulties, but without being diagnosed with mental illness. 23% of patients who were referred to NPMP had a psychiatric diagnosis as the first diagnosis. The full range of psychiatric diagnoses are represented, but the majority of patients were treated for anxiety and depression.
The investigators want to let people who have had NPMP treatment to consider what effect the treatment has given, measured by separate registrations of quality of life, pain, physical, mental and social functioning.
Detailed description
The primary aim of this is project intends to evaluate the effect of Norwegian psychomotor physiotherapy (NPMP) on Health related Quality of Life measured by Short-form Health Survey (SF-36). The secondary aims are to evaluate the effect of Norwegian psychomotor physiotherapy (NPMP) on the variables Subjective Health Complaints Inventory (SHC); Hopkins 's Symptom Check List , Örebro Screening for musculo-skeletal pain ,Numeric Pain Rating Scale , Oslo Social Support Scale , Coping and The self-esteem scale"
The study design is based on the guidelines for randomized controlled trials presented in the CONSORT statement. The study will address to people who have had NPMP treatment approach, and they will be asked to consider what effect the treatment has given, measured by separate registrations of quality of life, pain, physical, mental and social functioning.
Participants Power calculation based on the primary outcome Short-form Health Survey (SF-36) proved that minimum 170 participants must be recruited. The participants will be recruited among patients on the waiting list for NPMP by all psychomotor physiotherapists who are members of the Norwegian Physiotherapists Association. If patients want to participate in the study, they will be randomized to an intervention group and a control group by drawing lots.
The intervention group will have NPMP as usual in 6 months. The control group remains on the waiting list for 6 months. Participants in both groups will be asked to fill out the self-assessment questionnaire at the start of the project and at the completion of the project after six months. Participants in the intervention group will receive the same form after 12 months, to examine whether there have been any subsequent change after completion NPMF.
Timing of surveys:
Participants will be given questionnaires by the NPMP physiotherapist at
- Baseline - 2 weeks before NPMF (both groups)
- After 6 months (both groups)
- After 12 months (intervention group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention:Control group | No intervention | – |
| Individual NPMP to the participants | Experimental | Behavioral: Individual NPMP to the participantsThis arm will receive NPMP for 6 months, individually adjusted to their problems. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being referred to NPMP
- Being able to give informed consent
- The therapist finds the NPMP to be a proper treatment to this patient
Key exclusion criteria (1 listed)
- 1. Do not understand Norwegian
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 |
|---|---|---|
| Individual NPMP to the participantsThe participants in the intervention group will receive NPMP individually adjusted for six months. NPMP is not a standardized treatment approach, but individually adjusted to the individual patient according to their individual problems. | Behavioural | Individual NPMP to the participants |
Primary outcome
Change from baseline in Short-form Health Survey (SF-36) at 6 months
Time frame: 6 months
This will be assessed for both the control group and the intervention group.
Change from baseline in Short-form Health Survey (SF-36) at 12 months
Time frame: 12 months
This outcome measure will be assessed only for the intervention group.
6 secondary outcomes
Change from baseline in Subjective Health Complaints Inventory (SHC) at 6 months
Time frame: 6 months
Change from baseline in Subjective Health Complaints Inventory (SHC) at 12 months
Time frame: 12 months
Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 6 months
Time frame: 6 months
Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 12 months
Time frame: 12 months
Change from baseline in Örebro Screening for musculo-skeletal pain (Linton et al., 2011) at 6 months
Time frame: 6 months
Change from baseline in Örebro Screening for musculo-skeletal pain (Linton et al., 2011) at 12 months
Time frame: 12 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 6 Oct 2022.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Astrid Bergland, Phd principal investigator
Oslo Metropolitan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual NPMP to the participants in people with Pain and Stress, run by Oslo Metropolitan University at 2 sites 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 3 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 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change from baseline in Short-form Health Survey (SF-36) at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2022.