Individually Tailored Web-based Multimodal Pain Rehabilitation in Primary Health Care

NCT ID: NCT01475591

Last Updated: 2016-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Musculoskeletal Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Multimodal rehabilitation

The arm intervention is just multimodal rehabilitation.

Group Type NO_INTERVENTION

Web-based multimodal rehabilitation based on cognitive based principles

Intervention Type BEHAVIORAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Web-based multimodal rehabilitation based on cognitive based principles

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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%

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

63 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Norrbottens County Council

OTHER_GOV

Sponsor Role collaborator

Luleå Tekniska Universitet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peter Michaelson

Senior lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gunvor Gard, Professor

Role: PRINCIPAL_INVESTIGATOR

Luleå University of Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Primary health care centers in Norrbotten county council

Luleå, Norrbotten County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28464364 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27707686 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REHSAM_NLL_LTU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.