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Norwegian Psychomotor Physiotherapy - The Effect on Quality of Life

Primary Purpose

Pain, Stress, Psychosomatic Diseases

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Individual NPMP to the participants
Sponsored by
Oslo Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Quality of life

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oslo and Akershus University College of Applied Sciences
  • HIOA

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Intervention:Control group

Individual NPMP to the participants

Arm Description

This arm will receive NPMP for 6 months, individually adjusted to their problems.

Outcomes

Primary Outcome Measures

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.
Change from baseline in Short-form Health Survey (SF-36) at 12 months
This outcome measure will be assessed only for the intervention group.

Secondary Outcome Measures

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.
Change from baseline in Subjective Health Complaints Inventory (SHC) at 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
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
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
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
This outcome measure will be assessed only for the intervention group.

Full Information

First Posted
March 17, 2014
Last Updated
October 5, 2022
Sponsor
Oslo Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT02282007
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo Metropolitan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Stress, Psychosomatic Diseases, Muscle Skeletal Disorders
Keywords
Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Intervention:Control group
Arm Type
No Intervention
Arm Title
Individual NPMP to the participants
Arm Type
Experimental
Arm Description
This arm will receive NPMP for 6 months, individually adjusted to their problems.
Intervention Type
Behavioral
Intervention Name(s)
Individual NPMP to the participants
Intervention Description
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 Measure Information:
Title
Change from baseline in Short-form Health Survey (SF-36) at 6 months
Description
This will be assessed for both the control group and the intervention group.
Time Frame
6 months
Title
Change from baseline in Short-form Health Survey (SF-36) at 12 months
Description
This outcome measure will be assessed only for the intervention group.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from baseline in Subjective Health Complaints Inventory (SHC) at 6 months
Description
This will be assessed for both the control group and the intervention group.
Time Frame
6 months
Title
Change from baseline in Subjective Health Complaints Inventory (SHC) at 12 months
Description
This outcome measure will be assessed only for the intervention group.
Time Frame
12 months
Title
Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 6 months
Description
This will be assessed for both the control group and the intervention group.
Time Frame
6 months
Title
Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 12 months
Description
This outcome measure will be assessed only for the intervention group.
Time Frame
12 months
Title
Change from baseline in Örebro Screening for musculo-skeletal pain (Linton et al., 2011) at 6 months
Description
This outcome measure will be assessed both for the Control Group and for the intervention group.
Time Frame
6 months
Title
Change from baseline in Örebro Screening for musculo-skeletal pain (Linton et al., 2011) at 12 months
Description
This outcome measure will be assessed only for the intervention group.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Change from baseline in Numeric Pain Rating Scale (NPRS) at 6 months
Description
This outcome measure will be assessed both for the Control Group and for the intervention group.
Time Frame
6 months
Title
Change from baseline in Numeric Pain Rating Scale (NPRS) at 12 months
Description
This outcome measure will be assessed only for the intervention group.
Time Frame
12 months
Title
Change from Baseline in Oslo Social Support Scale (OSS-3) at 6 months
Description
This outcome measure will be assessed both for the Control Group and for the intervention group.
Time Frame
6 months
Title
Change from Baseline in Oslo Social Support Scale (OSS-3) at 12 months
Description
This outcome measure will be assessed only for the intervention group.
Time Frame
12 months
Title
Change from Baseline in Coping, (Pearlin & Schooler, 1978) at 6 months
Description
This outcome measure will be assessed both for the Control Group and for the intervention group.
Time Frame
6 months
Title
Change from Baseline in Coping, (Pearlin & Schooler, 1978) at 12 months
Description
This outcome measure will be assessed only for the intervention group.
Time Frame
12 months
Title
Change from Baseline in The self-esteem scale" (Rosenberg 1965) at 6 months
Description
This outcome measure will be assessed both for the Control Group and for the intervention group.
Time Frame
6 months
Title
Change from Baseline in The self-esteem scale" (Rosenberg 1965) at 12 months
Description
This outcome measure will be assessed only for the intervention group.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being referred to NPMP Being able to give informed consent The therapist finds the NPMP to be a proper treatment to this patient Exclusion Criteria: 1. Do not understand Norwegian
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid Bergland, Phd
Organizational Affiliation
Oslo Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo and Akershus University College of Applied Sciences
City
Oslo
ZIP/Postal Code
N130
Country
Norway
Facility Name
HIOA
City
Oslo
Country
Norway

12. IPD Sharing Statement

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