NCT01475591

Brief Summary

The aim is to evaluate effects of early individually tailored web-based multimodal rehabilitation for persons with musculoskeletal neck/shoulder and back disorders in primary health care. The aim is also to study if this early web-based pain rehabilitation program is more cost-effective than only multimodal rehabilitation. Randomization will be done at each primary health care centre after screening to 1) Multimodal pain rehabilitation with web-based education and coaching support or 2) multimodal pain rehabilitation. The investigators suggest a clear rehabilitation chain where a web-based program is developed,evaluated and ready to implement if it shows positive effects on work-ability and/or is cost-effective. The research and implementation will be performed in a close cooperation with Luleå University of Technology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 21, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

2.7 years

First QC Date

November 1, 2011

Last Update Submit

September 22, 2016

Conditions

Musculoskeletal Pain

Keywords

persistent neuromusculoskeletal painneckshoulderback-arearisklonglastingpain syndrome

Outcome Measures

Primary Outcomes (1)

  • Work ability

    4 month

Secondary Outcomes (4)

  • Pain rating

    12 month

  • Self-efficacy in relation to workability

    12 month

  • General health

    12 month

  • Functional status

    12 month

Study Arms (1)

Multimodal rehabilitation

NO INTERVENTION

The arm intervention is just multimodal rehabilitation.

Behavioral: Web-based multimodal rehabilitation based on cognitive based principles

Interventions

Web-based multimodal rehabilitation based on cognitive based principlesBEHAVIORAL

The patient will be randomized to either the interventions group (multimodal pain rehabilitation with an added web-based multimodal rehabilitation with CBT-influences) or a control group (multimodal pain rehabilitation).

Multimodal rehabilitation

Eligibility Criteria

Age18 Years - 63 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • With persistent neuromusculoskeletal pain from the neck/shoulder/back-area and/or fibromyalgia and a screening
  • \> 90 on Lintons´ questionnaire, The Örebro Musculoskeletal Pain Questionnaire (Linton \& Halldén., 1998; Hockings et.al., 2008)
  • Fluent in Swedish language
  • Working, or in disposition to at least 25%

You may not qualify if:

  • Dementia
  • Restricted cognitive functioning
  • Comorbidity which might prevent treatment participation
  • Identified abuse, retirement pension
  • Ongoing causal treatment
  • Pregnancy
  • Patients lacking internet attached computers in their home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary health care centers in Norrbotten county council

Luleå, Norrbotten County, Sweden

Location

Related Publications (2)

  • Calner T, Nordin C, Eriksson MK, Nyberg L, Gard G, Michaelson P. Effects of a self-guided, web-based activity programme for patients with persistent musculoskeletal pain in primary healthcare: A randomized controlled trial. Eur J Pain. 2017 Jul;21(6):1110-1120. doi: 10.1002/ejp.1012. Epub 2017 May 2.

    PMID: 28464364DERIVED

  • Nordin CA, Michaelson P, Gard G, Eriksson MK. Effects of the Web Behavior Change Program for Activity and Multimodal Pain Rehabilitation: Randomized Controlled Trial. J Med Internet Res. 2016 Oct 5;18(10):e265. doi: 10.2196/jmir.5634.

    PMID: 27707686DERIVED

MeSH Terms

Conditions

Musculoskeletal PainSomatoform Disorders

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Gunvor Gard, Professor

    Luleå University of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 21, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2015

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

SE(1)