Physical Activity and Acceptance and Commitment Therapy as Treatment for Long Term Pain

Chronic Pain Clinical Trial

— FACTA  

Official title:

Physical Activity and Acceptance and Commitment Therapy as Treatment for Long Term Pain. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399644
• Other study ID #: REHSAM_RS2010/002
• Status: Completed
• Phase: N/A
• First received: January 21, 2015
• Last updated: October 14, 2017
• Start date: January 2011
• Est. completion date: July 2015

Study information

• Verified date: March 2015
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• ACT
ACT is a type of Cognitive behavioral Therapy (CBT) that focuses on acceptance and mindfulness. The aim is to prevent avoidance and control of negative private events such as anxiety or pain. The treatment consists of 7 weekly group sessions, 2 hours a week. The participants are given homework between sessions.

Other:
• Physical activity
Participants are going to perform a training programme including aerobic exercise as well as endurance and strength training for the neck, shoulders, low back, core and leg muscles. The training is group-based and supervised by a physiotherapist two times a week, one hour a time for eight weeks. Home exercises twice a week are also a part of the intervention. It is possible to individually adjust movements and intensity to the participants' capacity if needed.

Locations

Country	Name	City	State
Sweden	Rehabilitation medicine, IMH, Linköping University	Linköping	Ostergotland

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain intensity	Pain intensity recent 7 days using a numeric rating scale	Change from baseline pain intensity at 12 months
Primary	Change in Depression	Depression scale of Hospital Anxiety and Depression Scale (HADS)	Change from baseline depression at 12 months
Primary	Change in Catastrophizing	The Pain Catastrophizing Scale (PCS)	Change from baseline catastrophizing at 12 months
Primary	Change in Acceptance	The Chronic Pain Acceptance Questionnaire (CPAQ)	Change from baseline acceptance at 12 months
Primary	Change in Disability	Pain Disability Index (PDI)	Change from baseline disability at 12 months
Secondary	Change in Flexibility	The Psychological Inflexibility in Pain Scale (PIPS)	Change from baseline flexibility at 12 months
Secondary	Change in Insomnia	The Insomnia Severity Index (ISI)	Change from baseline insomnia at 12 months
Secondary	Change in Fear-avoidance beliefs	Fear-Avoidance Beliefs Questionnaire (FABQ)	Change from baseline fear-avoidance at 12 months
Secondary	Change in Disability2	Oswestry Disability Index (ODI)	Change from baseline disability2 at 12 months
Secondary	Change in Health	The EuroQol instrument	Change from baseline health at 12 months
Secondary	Change in Life satisfaction	The Life Satisfaction Questionnaire.	Change from baseline life satisfaction at 12 months