Clinical Trial: Norwegian Psychomotor Physiotherapy - The Effect on Quality of Life

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Norwegian Psychomotor Physiotherapy - The Effect on Quality of Life, The Feeling of Pain, Coping, Physical, Psychological and Social Functioning After the 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 Summary:

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.

Sponsor: Oslo and Akershus University College of Applied Sciences

Current 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change from baseline in Subjective Health Complaints Inventory (SHC) at 6 months [ Time Frame: 6 months ]
  This will be assessed for both the control group and the intervention group.
• Change from baseline in Subjective Health Complaints Inventory (SHC) at 12 months [ Time Frame: 12 months ]
  This outcome measure will be assessed only for the intervention group.
• Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 6 months [ Time Frame: 6 months ]
  This will be assessed for both the control group and the intervention group.
• Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 12 months [ Time Frame: 12 months ]
  This outcome measure will be assessed only for the intervention group.
• Change from baseline in Örebro Screening for musculo-skeletal pain (Linton et al., 2011) at 6 months [ Time Frame: 6 months ]
  This outcome measure will be assessed both for the Control Group and for the intervention group.
• Change from baseline in Örebro Screening for musculo-skeletal pain (Linton et al., 2011) at 12 months [ Time Frame: 12 months ]
  This outcome measure will be assessed only for the intervention group.

Original Secondary Outcome: Same as current

Information By: Oslo and Akershus University College of Applied Sciences

Dates:
Date Received: March 17, 2014
Date Started: February 2014
Date Completion: July 2017
Last Updated: June 23, 2016
Last Verified: June 2016