NCT01447953

Brief Summary

The primary goal of the Swedish national rehabilitation plan on pain is to reduce disability and facilitate return-to-work. However, there is a lack of treatment strategies that effectively target and affect return-to-work and reduce sickness absence, and that in addition are sufficiently easy and feasible to administer in primary care. A new activity and life-role targeting rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work. The program will be implemented and provided as one of the pain treatment modalities available through multi-professional teams in primary care in one Swedish county. This study aims to evaluate the effect of an activity and life-role targeting pain rehabilitation program on the outcome variables return-to-work and sickness absence.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
65

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
terminated

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

First Submitted

Initial submission to the registry

September 9, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

September 9, 2011

Last Update Submit

December 14, 2015

Conditions

Musculoskeletal Neck PainMusculoskeletal Shoulder Pain

Keywords

Activitydisabilitylife-rolemultimodal rehabilitationprimary health carepersistent painrandomized controlled trialMusculoskeletal back pain

Outcome Measures

Primary Outcomes (3)

  • Number of days of sickness absence from work

    Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.

    6 months

  • Number of days of sickness absence from work

    Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.

    1 year

  • Number of days of sickness absence from work

    Number of days of sickness absence from work during a 3-month period preceding the baseline measurement and preceding each follow-up, and specified in percent of full-time work.

    2 years

Secondary Outcomes (2)

  • Return-to-work after sickness absence

    Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)

  • Disability

    Before treatment (at baseline), with follow-ups at 6 months, 1 , 2 and 5 years after treatment (after baseline assessment)

Study Arms (2)

Activity targeted pain rehabilitation

EXPERIMENTAL

A new activity and life-role targeting pain rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work.

Other: Activity targeted pain rehabilitation

Treatment as usual

ACTIVE COMPARATOR

Usual treatment consisting of multimodal rehabilitation provided by multi-professional teams in primary health care in the County of Dalarna, Sweden.

Other: Treatment as usual

Interventions

Activity targeted pain rehabilitationOTHER

An activity and life-role targeting rehabilitation programme (ALAR) provided by one of the care givers in the multi-professional rehabilitation teams at each of the eight participating primary health care centres, by ten weekly 1-hour treatment sessions.

Activity targeted pain rehabilitation
Treatment as usualOTHER

Usual treatment with type of treatment modalities, number, frequency and duration of visits according to the judgement of the muli-professional teams at each primary health care centre.

Treatment as usual

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Persons seeking primary health care due to back, neck or shoulder pain
  • Aged 18 to 60 years
  • Being on sick leave or disability compensation
  • Able to understand, read and write Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The County Council of Dalarna; Primary Health Care units

Falun, 79182, Sweden

Location

MeSH Terms

Conditions

Shoulder PainMotor Activity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Registered Physical Therapist PhD

Study Record Dates

First Submitted

September 9, 2011

First Posted

October 6, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2015

Last Updated

December 15, 2015

Record last verified: 2015-12

Locations

SE(1)