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TerminatedNCT01447953Updated Dec 15, 2015

Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care

An interventional study of Activity targeted pain rehabilitation and Treatment as usual in Musculoskeletal Neck Pain and Musculoskeletal Shoulder Pain, sponsored by Uppsala University. Terminated at 1 site in Sweden. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-12-15.

Sponsored by Uppsala University · Not applicable, Interventional, and Treatment

Why this study was terminated
Organizational changes in health care made further recruitment to the treatment options unpossible.
Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

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.

Patients seeking care due to disabling back, neck or shoulder pain at seven primary health care units in the County of Dalarna, Sweden, was randomly allocated to ALAR or usual multimodal rehabilitation. Between and within-group differences on return-to-work, sickness absence and disability will be evaluated at 10 weeks, six months, one and two years post-treatment.

The enrollment of patients was ended on preterm in june 2013. Due to changes in the organization in primary health care it was no longer possible to ensure that treatment arms could be delivered as intended. Data collection up to 1-year follow-up is completed. Data from longterm follow-up at 2 years will be completed in june 2015. Data analyses and reporting of results is presently undertaken. The number of enrolled participants is not enough to reach statistical power. Thus, results will need to be interpreted with caution.

Still the results of this pragmatic study will be of importance for the planning of a full scale study to accurately evaluate the effects of ALAR, to be conducted in primary care.

02

Conditions studied

  • Musculoskeletal Neck Pain
  • Musculoskeletal Shoulder Pain

Keywords

  • Activity
  • disability
  • life-role
  • multimodal rehabilitation
  • primary health care
  • persistent pain
  • randomized controlled trial
  • Musculoskeletal back pain
03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 65 is close to the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    Activity targeted pain rehabilitation

    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

  • Active comparator
    Treatment as usual

    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

  • OtherActivity targeted pain rehabilitation

    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.

  • OtherTreatment as usual

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 1 year

  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.

    Time frame: 2 years

Secondary outcomes

  1. Return-to-work after sickness absence

    Number of participants that return to work after sickness absence, i.e. that were on sick leave before the study and that has returned to work after the study.

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

  2. Disability

    Pain-related disability according to Pain Disability Index (PDI).

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

07

Study locations

1 site
  • The County Council of Dalarna; Primary Health Care units
    Falun, 79182, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01447953
Lead sponsor
Uppsala University
Collaborators
Center for Clinical Research Dalarna, Sweden, Dalarna County Council, Sweden, REHSAM, Sweden
Responsible party
Catharina Gustavsson, RPT PhD (Principal Investigator Registered Physical Therapist PhD, Uppsala University) — Principal investigator
First posted
Oct 6, 2011
Start date
Oct 2011
Primary completion
Jun 2013
Completion
Jun 2015
Last update
Dec 15, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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