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

NCT02399644 | Completed

• 1 other identifier: REHSAM_RS2010/002
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

pain; rehabilitation; exercise; psychological; intervention

Outcome Measures

Primary Outcomes (5)

• Change in Pain intensity

  Pain intensity recent 7 days using a numeric rating scale

  Change from baseline pain intensity at 12 months

• Change in Depression

  Depression scale of Hospital Anxiety and Depression Scale (HADS)

  Change from baseline depression at 12 months

• Change in Catastrophizing

  The Pain Catastrophizing Scale (PCS)

  Change from baseline catastrophizing at 12 months

• Change in Acceptance

  The Chronic Pain Acceptance Questionnaire (CPAQ)

  Change from baseline acceptance at 12 months

• Change in Disability

  Pain Disability Index (PDI)

  Change from baseline disability at 12 months

Secondary Outcomes (6)

• Change in Flexibility

  Change from baseline flexibility at 12 months

• Change in Insomnia

  Change from baseline insomnia at 12 months

• Change in Fear-avoidance beliefs

  Change from baseline fear-avoidance at 12 months

• Change in Disability2

  Change from baseline disability2 at 12 months

• Change in Health

  Change from baseline health at 12 months

Study Arms (3)

ACT

EXPERIMENTAL

Acceptance and Commitment Therapy is a version of Cognitive behavioral Therapy 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.

Behavioral: ACT

Physical activity

EXPERIMENTAL

Participants are going to participate in 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.

Other: Physical activity

Experience based discussion group

NO INTERVENTION

Participants are going to discuss their experiences of long term pain. The discussions is supervised by a heath care professional and is based on beforehand defined subjects, i.e. relations, spare time, economics, occupation. The meetings are hold for 7 weeks, 2 hours a week.

Interventions

ACT BEHAVIORAL

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.

ACT

Physical activity OTHER

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.

Physical activity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Rehabilitation medicine, IMH, Linköping University

Linköping, Östergötland County, SE 581 85, Sweden

Location

Related Publications (1)

• 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.

  PMID: 29631567 DERIVED

MeSH Terms

Conditions

Chronic Pain; Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Björn Gerdle, MD, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: March 26, 2015
• Study Start: January 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 17, 2017

Record last verified: 2015-03

Locations

SE (1)