NCT01356784

Brief Summary

TEst the effect of "Tailored Physical Activity" or "Chronic Pain Self-management Program" on Returning to Work in Sicklisted Citizens With Chronic Pain Related to the Spine or Upper Body

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2011

Typical duration for phase_1

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

May 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

2.2 years

First QC Date

May 13, 2011

Last Update Submit

April 22, 2014

Conditions

Keywords

Sick-listedTailored physical activityPatient educationReturning to workDK-Sønderborg Municipalitycolumnaupper body

Outcome Measures

Primary Outcomes (1)

  • Sick-listed or not

    Registration of the participants status as sick-listed or not and co-primary the number of days on sick-leave in the period.

    3 months

Secondary Outcomes (9)

  • Aerobic capacity

    3 months

  • hand-grip strength

    3 months

  • Body weight, waist circumference, hip circumference

    3 months

  • Questionnaire

    3 months

  • Sick-listed or not

    12-months follow-up

  • +4 more secondary outcomes

Study Arms (3)

Tailored Physical Activity

EXPERIMENTAL
Other: Tailored Physical Activity

"Chronic Pain Self-management Programme"

ACTIVE COMPARATOR
Behavioral: "Chronic Pain Self-management Programme"

Health Counselling

OTHER
Behavioral: Health counselling

Interventions

Health counselling (1,5h) and graded physical activity (3×50 min/week in 10 weeks)

Tailored Physical Activity

Health counselling (1,5h) and 'Chronic Pain Self-management Program' (2,5h in 6 weeks)

"Chronic Pain Self-management Programme"

Health guidance (1,5h)

Health Counselling

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sick-listed with musculoskeletal pain related to columna or the upper body for a maximum period of 9 weeks in DK-Sønderborg Municipality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Care Centre

Sønderborg, 6400, Denmark

Location

Related Publications (1)

  • Andersen LN, Juul-Kristensen B, Roessler KK, Herborg LG, Sorensen TL, Sogaard K. Efficacy of 'Tailored Physical Activity' or 'Chronic Pain Self-Management Program' on return to work for sick-listed citizens: design of a randomised controlled trial. BMC Public Health. 2013 Jan 23;13:66. doi: 10.1186/1471-2458-13-66.

Related Links

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.d. fellow

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 19, 2011

Study Start

May 1, 2011

Primary Completion

July 1, 2013

Study Completion

April 1, 2014

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations