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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ACT
Physical activity
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring pain, rehabilitation, exercise, psychological, intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation medicine, IMH, Linköping University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

ACT

Physical activity

Experience based discussion group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Pain intensity
Pain intensity recent 7 days using a numeric rating scale
Change in Depression
Depression scale of Hospital Anxiety and Depression Scale (HADS)
Change in Catastrophizing
The Pain Catastrophizing Scale (PCS)
Change in Acceptance
The Chronic Pain Acceptance Questionnaire (CPAQ)
Change in Disability
Pain Disability Index (PDI)

Secondary Outcome Measures

Change in Flexibility
The Psychological Inflexibility in Pain Scale (PIPS)
Change in Insomnia
The Insomnia Severity Index (ISI)
Change in Fear-avoidance beliefs
Fear-Avoidance Beliefs Questionnaire (FABQ)
Change in Disability2
Oswestry Disability Index (ODI)
Change in Health
The EuroQol instrument
Change in Life satisfaction
The Life Satisfaction Questionnaire.

Full Information

First Posted
January 21, 2015
Last Updated
October 14, 2017
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT02399644
Brief Title
Physical Activity and Acceptance and Commitment Therapy as Treatment for Long Term Pain
Acronym
FACTA
Official Title
Physical Activity and Acceptance and Commitment Therapy as Treatment for Long Term Pain. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
pain, rehabilitation, exercise, psychological, intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACT
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical activity
Arm Type
Experimental
Arm Description
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.
Arm Title
Experience based discussion group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ACT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical activity
Intervention Description
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 Outcome Measure Information:
Title
Change in Pain intensity
Description
Pain intensity recent 7 days using a numeric rating scale
Time Frame
Change from baseline pain intensity at 12 months
Title
Change in Depression
Description
Depression scale of Hospital Anxiety and Depression Scale (HADS)
Time Frame
Change from baseline depression at 12 months
Title
Change in Catastrophizing
Description
The Pain Catastrophizing Scale (PCS)
Time Frame
Change from baseline catastrophizing at 12 months
Title
Change in Acceptance
Description
The Chronic Pain Acceptance Questionnaire (CPAQ)
Time Frame
Change from baseline acceptance at 12 months
Title
Change in Disability
Description
Pain Disability Index (PDI)
Time Frame
Change from baseline disability at 12 months
Secondary Outcome Measure Information:
Title
Change in Flexibility
Description
The Psychological Inflexibility in Pain Scale (PIPS)
Time Frame
Change from baseline flexibility at 12 months
Title
Change in Insomnia
Description
The Insomnia Severity Index (ISI)
Time Frame
Change from baseline insomnia at 12 months
Title
Change in Fear-avoidance beliefs
Description
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time Frame
Change from baseline fear-avoidance at 12 months
Title
Change in Disability2
Description
Oswestry Disability Index (ODI)
Time Frame
Change from baseline disability2 at 12 months
Title
Change in Health
Description
The EuroQol instrument
Time Frame
Change from baseline health at 12 months
Title
Change in Life satisfaction
Description
The Life Satisfaction Questionnaire.
Time Frame
Change from baseline life satisfaction at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Björn Gerdle, MD, PhD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation medicine, IMH, Linköping University
City
Linköping
State/Province
Ostergotland
ZIP/Postal Code
SE 581 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
29631567
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.
Results Reference
derived

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

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