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

Primary Purpose

Musculoskeletal Pain

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Web-based multimodal rehabilitation based on cognitive based principles

About this trial

This is an interventional treatment trial for Musculoskeletal Pain focused on measuring persistent neuromusculoskeletal pain, neck, shoulder, back-area, risk, longlasting, pain syndrome

Eligibility Criteria

18 Years - 63 Years (Adult)All SexesDoes not accept healthy volunteers

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 are persons with:

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

Sites / Locations

Primary health care centers in Norrbotten county council

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Multimodal rehabilitation

Arm Description

The arm intervention is just multimodal rehabilitation.

Outcomes

Primary Outcome Measures

Work ability

Secondary Outcome Measures

Pain rating

Pain-rating is measured on a visual analog-scale

Self-efficacy in relation to workability

Self-efficacy in relation to work-ability is measured by a questionnarie

General health

General health is measured with SF-36 and EQ-5D.

Functional status

Functional status is measured with Pain disability index.

Full Information

NCT ID

NCT01475591

First Posted

November 1, 2011

Last Updated

September 22, 2016

Sponsor

Luleå Tekniska Universitet

Collaborators

Norrbottens County Council

1. Study Identification

Unique Protocol Identification Number

NCT01475591

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Luleå Tekniska Universitet

Collaborators

Norrbottens County Council

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Musculoskeletal Pain

Keywords

persistent neuromusculoskeletal pain, neck, shoulder, back-area, risk, longlasting, pain syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

N/A

Enrollment

109 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Multimodal rehabilitation

Arm Type

No Intervention

Arm Description

The arm intervention is just multimodal rehabilitation.

Intervention Type

Behavioral

Intervention Name(s)

Web-based multimodal rehabilitation based on cognitive based principles

Intervention Description

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).

Primary Outcome Measure Information:

Title

Work ability

Time Frame

4 month

Secondary Outcome Measure Information:

Title

Pain rating

Description

Pain-rating is measured on a visual analog-scale

Time Frame

12 month

Title

Self-efficacy in relation to workability

Description

Self-efficacy in relation to work-ability is measured by a questionnarie

Time Frame

12 month

Title

General health

Description

General health is measured with SF-36 and EQ-5D.

Time Frame

12 month

Title

Functional status

Description

Functional status is measured with Pain disability index.

Time Frame

12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

63 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 are persons with: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gunvor Gard, Professor

Organizational Affiliation

Luleå University of Technology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Primary health care centers in Norrbotten county council

City

Luleå

State/Province

Norrbotten

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

28464364

Citation

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.

Results Reference

derived

PubMed Identifier

27707686

Citation

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.

Results Reference

derived

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

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