Norwegian Psychomotor Physiotherapy - The Effect on Quality of Life

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282007
• Other study ID #: REK 2013/1913
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: July 2018

Study information

• Verified date: October 2022
• Source: Oslo Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Skeletal Disorders
• Pain
• Psychophysiologic Disorders
• Psychosomatic Diseases
• Stress

Intervention

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.

Locations

Country	Name	City	State
Norway	HIOA	Oslo
Norway	Oslo and Akershus University College of Applied Sciences	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo Metropolitan University

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in Numeric Pain Rating Scale (NPRS) at 6 months	This outcome measure will be assessed both for the Control Group and for the intervention group.	6 months
Other	Change from baseline in Numeric Pain Rating Scale (NPRS) at 12 months	This outcome measure will be assessed only for the intervention group.	12 months
Other	Change from Baseline in Oslo Social Support Scale (OSS-3) at 6 months	This outcome measure will be assessed both for the Control Group and for the intervention group.	6 months
Other	Change from Baseline in Oslo Social Support Scale (OSS-3) at 12 months	This outcome measure will be assessed only for the intervention group.	12 months
Other	Change from Baseline in Coping, (Pearlin & Schooler, 1978) at 6 months	This outcome measure will be assessed both for the Control Group and for the intervention group.	6 months
Other	Change from Baseline in Coping, (Pearlin & Schooler, 1978) at 12 months	This outcome measure will be assessed only for the intervention group.	12 months
Other	Change from Baseline in The self-esteem scale" (Rosenberg 1965) at 6 months	This outcome measure will be assessed both for the Control Group and for the intervention group.	6 months
Other	Change from Baseline in The self-esteem scale" (Rosenberg 1965) at 12 months	This outcome measure will be assessed only for the intervention group.	12 months
Primary	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.	6 months
Primary	Change from baseline in Short-form Health Survey (SF-36) at 12 months	This outcome measure will be assessed only for the intervention group.	12 months
Secondary	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.	6 months
Secondary	Change from baseline in Subjective Health Complaints Inventory (SHC) at 12 months	This outcome measure will be assessed only for the intervention group.	12 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	6 months
Secondary	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.	12 months