NCT02282007

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

4.4 years

First QC Date

March 17, 2014

Last Update Submit

October 5, 2022

Conditions

PainStressPsychosomatic DiseasesMuscle Skeletal Disorders

Keywords

Quality of life

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Change from baseline in Subjective Health Complaints Inventory (SHC) at 6 months

    6 months

  • Change from baseline in Subjective Health Complaints Inventory (SHC) at 12 months

    12 months

  • Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 6 months

    6 months

  • Change from baseline in Hopkins 's Symptom Check List (Lipman et al., 1979) at 12 months

    12 months

  • Change from baseline in Örebro Screening for musculo-skeletal pain (Linton et al., 2011) at 6 months

    6 months

  • +1 more secondary outcomes

Other Outcomes (8)

  • Change from baseline in Numeric Pain Rating Scale (NPRS) at 6 months

    6 months

  • Change from baseline in Numeric Pain Rating Scale (NPRS) at 12 months

    12 months

  • Change from Baseline in Oslo Social Support Scale (OSS-3) at 6 months

    6 months

  • +5 more other outcomes

Study Arms (2)

No Intervention:Control group

NO INTERVENTION

Individual NPMP to the participants

EXPERIMENTAL

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

Behavioral: Individual NPMP to the participants

Interventions

Individual NPMP to the participantsBEHAVIORAL

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.

Individual NPMP to the participants

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being referred to NPMP
  • Being able to give informed consent
  • The therapist finds the NPMP to be a proper treatment to this patient

You may not qualify if:

  • \. Do not understand Norwegian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oslo and Akershus University College of Applied Sciences

Oslo, N130, Norway

Location

HIOA

Oslo, Norway

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Astrid Bergland, Phd

    Oslo Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 17, 2014

First Posted

November 4, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

October 6, 2022

Record last verified: 2022-10

Locations

NO(2)