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Completed

NCT Number: NCT02399644

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

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.

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Key information

Conditions

Chronic Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation medicine, IMH, Linköping University

Linköping, Östergötland County, SE 581 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Pain intensity

    Time frame: Change from baseline pain intensity at 12 months

    Pain intensity recent 7 days using a numeric rating scale

  2. Change in Depression

    Time frame: Change from baseline depression at 12 months

    Depression scale of Hospital Anxiety and Depression Scale (HADS)

  3. Change in Catastrophizing

    Time frame: Change from baseline catastrophizing at 12 months

    The Pain Catastrophizing Scale (PCS)

  4. Change in Acceptance

    Time frame: Change from baseline acceptance at 12 months

    The Chronic Pain Acceptance Questionnaire (CPAQ)

  5. Change in Disability

    Time frame: Change from baseline disability at 12 months

    Pain Disability Index (PDI)

Secondary outcomes

  1. Change in Flexibility

    Time frame: Change from baseline flexibility at 12 months

    The Psychological Inflexibility in Pain Scale (PIPS)

  2. Change in Insomnia

    Time frame: Change from baseline insomnia at 12 months

    The Insomnia Severity Index (ISI)

  3. Change in Fear-avoidance beliefs

    Time frame: Change from baseline fear-avoidance at 12 months

    Fear-Avoidance Beliefs Questionnaire (FABQ)

  4. Change in Disability2

    Time frame: Change from baseline disability2 at 12 months

    Oswestry Disability Index (ODI)

  5. Change in Health

    Time frame: Change from baseline health at 12 months

    The EuroQol instrument

  6. Change in Life satisfaction

    Time frame: Change from baseline life satisfaction at 12 months

    The Life Satisfaction Questionnaire.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

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

Acronym: FACTA

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2015
Registry last updated
Oct 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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