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Norwegian Psychomotor Physiotherapy - The Effect on Quality of Life

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ClinicalTrials.gov Identifier: NCT02282007
Recruitment Status : Unknown
Verified June 2016 by Astrid Bergland, Oslo and Akershus University College of Applied Sciences.
Recruitment status was:  Recruiting
First Posted : November 4, 2014
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Astrid Bergland, Oslo and Akershus University College of Applied Sciences

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.


Condition or disease Intervention/treatment Phase
Pain Stress Psychosomatic Diseases Muscle Skeletal Disorders Behavioral: Individual NPMP to the participants Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : February 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
No Intervention: No Intervention:Control group
Experimental: Individual NPMP to the participants
This arm will receive NPMP for 6 months, individually adjusted to their problems.
Behavioral: Individual NPMP to the participants
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Other Outcome Measures:
  1. Change from baseline in Numeric Pain Rating Scale (NPRS) at 6 months [ Time Frame: 6 months ]
    This outcome measure will be assessed both for the Control Group and for the intervention group.

  2. Change from baseline in Numeric Pain Rating Scale (NPRS) at 12 months [ Time Frame: 12 months ]
    This outcome measure will be assessed only for the intervention group.

  3. Change from Baseline in Oslo Social Support Scale (OSS-3) at 6 months [ Time Frame: 6 months ]
    This outcome measure will be assessed both for the Control Group and for the intervention group.

  4. Change from Baseline in Oslo Social Support Scale (OSS-3) at 12 months [ Time Frame: 12 months ]
    This outcome measure will be assessed only for the intervention group.

  5. Change from Baseline in Coping, (Pearlin & Schooler, 1978) at 6 months [ Time Frame: 6 months ]
    This outcome measure will be assessed both for the Control Group and for the intervention group.

  6. Change from Baseline in Coping, (Pearlin & Schooler, 1978) at 12 months [ Time Frame: 12 months ]
    This outcome measure will be assessed only for the intervention group.

  7. Change from Baseline in The self-esteem scale" (Rosenberg 1965) at 6 months [ Time Frame: 6 months ]
    This outcome measure will be assessed both for the Control Group and for the intervention group.

  8. Change from Baseline in The self-esteem scale" (Rosenberg 1965) at 12 months [ Time Frame: 12 months ]
    This outcome measure will be assessed only for the intervention group.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282007


Contacts
Contact: Kirsten Ekerholt, assoc. prof. +4722452509 kirsten.ekerholt@hioa.no
Contact: Astrid Bergland, PhD +4767236309 astrid.bergland@hioa.no

Locations
Norway
Oslo and Akershus University College of Applied Sciences Recruiting
Oslo, Norway, N130
Contact: Kirsten Ekerholt, MSc    +4722452509    kirsten.ekerholt@hioa.no   
Contact: Astrid Bergland, PhD    +4767236309    astrid.bergland@hioa.no   
Principal Investigator: Astrid Bergland, PhD         
HIOA Recruiting
Oslo, Norway
Contact: Kirsten Ekerholt         
Sponsors and Collaborators
Oslo and Akershus University College of Applied Sciences
Investigators
Principal Investigator: Astrid Bergland, Phd Oslo and Akershus University College of Applied Sciences

Responsible Party: Astrid Bergland, Professor, Oslo and Akershus University College of Applied Sciences
ClinicalTrials.gov Identifier: NCT02282007     History of Changes
Other Study ID Numbers: REK 2013/1913
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016

Keywords provided by Astrid Bergland, Oslo and Akershus University College of Applied Sciences:
Quality of life

Additional relevant MeSH terms:
Psychophysiologic Disorders
Neurologic Manifestations
Signs and Symptoms