Clinical trial NCT02282007: Norwegian Psychomotor Physiotherapy - The Effect on Quality of Life
Official title: Norwegian Psychomotor Physiotherapy - The Effect on Quality of Life, The Feeling of Pain, Coping, Physical, Psychological and Social Functioning After the Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Stress
Psychosomatic Diseases
Muscle Skeletal Disorders
Keywords: Quality of life
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

1. Being referred to NPMP
2. Being able to give informed consent
3. The therapist finds the NPMP to be a proper treatment to this patient

Exclusion Criteria:

1. Do not understand Norwegian

Primary outcomes:
measure: Change from baseline in Short-form Health Survey (SF-36) at 6 months
timeFrame: 6 months
measure: Change from baseline in Short-form Health Survey (SF-36) at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline in Subjective Health Complaints Inventory (SHC) at 6 months
timeFrame: 6 months
measure: Change from baseline in Subjective Health Complaints Inventory (SHC) at 12 months
timeFrame: 12 months
measure: Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 6 months
timeFrame: 6 months
measure: Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 12 months
timeFrame: 12 months
measure: Change from baseline in Örebro Screening for musculo-skeletal pain (Linton et al., 2011) at 6 months
timeFrame: 6 months
measure: Change from baseline in Örebro Screening for musculo-skeletal pain (Linton et al., 2011) at 12 months
timeFrame: 12 months
Other outcomes:
measure: Change from baseline in Numeric Pain Rating Scale (NPRS) at 6 months
timeFrame: 6 months
measure: Change from baseline in Numeric Pain Rating Scale (NPRS) at 12 months
timeFrame: 12 months
measure: Change from Baseline in Oslo Social Support Scale (OSS-3) at 6 months
timeFrame: 6 months
measure: Change from Baseline in Oslo Social Support Scale (OSS-3) at 12 months
timeFrame: 12 months
measure: Change from Baseline in Coping, (Pearlin & Schooler, 1978) at 6 months
timeFrame: 6 months
measure: Change from Baseline in Coping, (Pearlin & Schooler, 1978) at 12 months
timeFrame: 12 months
measure: Change from Baseline in The self-esteem scale" (Rosenberg 1965) at 6 months
timeFrame: 6 months
measure: Change from Baseline in The self-esteem scale" (Rosenberg 1965) at 12 months
timeFrame: 12 months
Locations:
city: Oslo
country: Norway
facility: Oslo and Akershus University College of Applied Sciences
city: Oslo
country: Norway
facility: HIOA
Study officials:
affiliation: Oslo Metropolitan University
name: Astrid Bergland, Phd
role: PRINCIPAL_INVESTIGATOR
References: