Clinical trial NCT02399644: Physical Activity and Acceptance and Commitment Therapy as Treatment for Long Term Pain
Official title: Physical Activity and Acceptance and Commitment Therapy as Treatment for Long Term Pain. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: pain
rehabilitation
exercise
psychological
intervention
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2015-03-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Only to a limited extent has been compared the effectiveness of physical exercise and psychological interventions in subjects with chronic pain. Knowledge about this is necessary in order to compose optimal multimodal rehabilitation programs at different health care levels. Moreover, assuming that both types of interventions have effects, these effects may necessarily not concern the same outcome variables. Therefore it may be important to understand to what extent the effects overlap and the extent to which the effects are isolated to an intervention.

The overall strategic purpose of the present study is to develop effective multimodal rehabilitation programs. In this study the effectiveness of following three interventions are compared.

* Group-based rehabilitation according to a concept based on an Acceptance and Commitment Training -Stress Management Intervention (ACT-SMI)
* Group-based rehabilitation compromised of physical exercise (Exercise).
* Group-based discussion concerning pain and its consequences (i.e., the control group, CON) The effectiveness is investigated with respect to long-term effects on pain and its consequences, including perceived health and return to work / sick leave.

The overall hypothesis is that the former intervention means better long-term results because it clearly helps the individual to process the psychological aspects of itself likely to have long lasting effects.


Eligibility criteria: Inclusion Criteria:

* chronic pain in the neck and/or back with or without pain in one or more quadrants of the body

Exclusion Criteria:

* Inflammatory and neurological diseases, severe social and/or psychological problems, patients that already have taken part in multidisciplinary rehabilitation programs

Primary outcomes:
measure: Change in Pain intensity
timeFrame: Change from baseline pain intensity at 12 months
measure: Change in Depression
timeFrame: Change from baseline depression at 12 months
measure: Change in Catastrophizing
timeFrame: Change from baseline catastrophizing at 12 months
measure: Change in Acceptance
timeFrame: Change from baseline acceptance at 12 months
measure: Change in Disability
timeFrame: Change from baseline disability at 12 months
Secondary outcomes:
measure: Change in Flexibility
timeFrame: Change from baseline flexibility at 12 months
measure: Change in Insomnia
timeFrame: Change from baseline insomnia at 12 months
measure: Change in Fear-avoidance beliefs
timeFrame: Change from baseline fear-avoidance at 12 months
measure: Change in Disability2
timeFrame: Change from baseline disability2 at 12 months
measure: Change in Health
timeFrame: Change from baseline health at 12 months
measure: Change in Life satisfaction
timeFrame: Change from baseline life satisfaction at 12 months
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Rehabilitation medicine, IMH, Linköping University
state: Ostergotland
Study officials:
affiliation: Linkoeping University
name: Björn Gerdle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wiklund T, Linton SJ, Alfoldi P, Gerdle B. Is sleep disturbance in patients with chronic pain affected by physical exercise or ACT-based stress management? - A randomized controlled study. BMC Musculoskelet Disord. 2018 Apr 10;19(1):111. doi: 10.1186/s12891-018-2020-z.