Chronic PainFACTANCT02399644
Physical Activity and Acceptance and Commitment Therapy as Treatment for Long Term Pain
A study testing ACT and Physical activity in people with Chronic Pain, run by Linkoeping University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- ACT and Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2011to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic pain in the neck and/or back with or without pain in one or more quadrants of the body
Who cannot join
- Inflammatory and neurological diseases, severe social and/or psychological problems, patients that already have taken part in multidisciplinary rehabilitation programs
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Rehabilitation medicine, IMH, Linköping University
Linköping, Östergötland County, SE 581 85
About this study
Official title: Physical Activity and Acceptance and Commitment Therapy as Treatment for Long Term Pain. A Randomized Controlled Trial
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.
Read more
- 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
- Being tested
- ACT, Physical activity
- Keywords
- pain, rehabilitation, exercise, psychological, intervention
- Medical subject headings
- Chronic Pain, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTBehavioural
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 activityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain intensity
Pain intensity recent 7 days using a numeric rating scale
Measured: Change from baseline pain intensity at 12 months
Change in Depression
Depression scale of Hospital Anxiety and Depression Scale (HADS)
Measured: Change from baseline depression at 12 months
Change in Catastrophizing
The Pain Catastrophizing Scale (PCS)
Measured: Change from baseline catastrophizing at 12 months
Change in Acceptance
The Chronic Pain Acceptance Questionnaire (CPAQ)
Measured: Change from baseline acceptance at 12 months
Change in Disability
Pain Disability Index (PDI)
Measured: Change from baseline disability at 12 months
Secondary outcomes (6)
Change in Flexibility
The Psychological Inflexibility in Pain Scale (PIPS)
Measured: Change from baseline flexibility at 12 months
Change in Insomnia
The Insomnia Severity Index (ISI)
Measured: Change from baseline insomnia at 12 months
Change in Fear-avoidance beliefs
Fear-Avoidance Beliefs Questionnaire (FABQ)
Measured: Change from baseline fear-avoidance at 12 months
Change in Disability2
Oswestry Disability Index (ODI)
Measured: Change from baseline disability2 at 12 months
Change in Health
The EuroQol instrument
Measured: Change from baseline health at 12 months
Change in Life satisfaction
The Life Satisfaction Questionnaire.
Measured: Change from baseline life satisfaction at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startJan 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bjorn Gerdle, Linkoeping University
- Investigators
- Björn Gerdle, MD, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399644
- Sponsor's protocol ID
- REHSAM_RS2010/002
- Acronym
- FACTA
- Status last verified
- Mar 2015
- First submitted
- 21 Jan 2015
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29631567
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Acceptance and Commitment Therapy as Treatment for Long Term Pain. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02399644
- Acronym / sponsor ID
- FACTA / REHSAM_RS2010/002
- Conditions
- Chronic Pain
- Keywords
- pain, rehabilitation, exercise, psychological, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Jan 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACT | Experimental | Behavioral: ACTAcceptance 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. |
| Physical activity | Experimental | Other: Physical activityParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic pain in the neck and/or back with or without pain in one or more quadrants of the body
Key exclusion criteria (1 listed)
- Inflammatory and neurological diseases, severe social and/or psychological problems, patients that already have taken part in multidisciplinary rehabilitation programs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTACT 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. | Behavioural | ACT |
| Physical activityParticipants 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. | Other | Physical activity |
Primary outcome
Change in Pain intensity
Time frame: Change from baseline pain intensity at 12 months
Pain intensity recent 7 days using a numeric rating scale
Change in Depression
Time frame: Change from baseline depression at 12 months
Depression scale of Hospital Anxiety and Depression Scale (HADS)
Change in Catastrophizing
Time frame: Change from baseline catastrophizing at 12 months
The Pain Catastrophizing Scale (PCS)
Change in Acceptance
Time frame: Change from baseline acceptance at 12 months
The Chronic Pain Acceptance Questionnaire (CPAQ)
Change in Disability
Time frame: Change from baseline disability at 12 months
Pain Disability Index (PDI)
6 secondary outcomes
Change in Flexibility
Time frame: Change from baseline flexibility at 12 months
Change in Insomnia
Time frame: Change from baseline insomnia at 12 months
Change in Fear-avoidance beliefs
Time frame: Change from baseline fear-avoidance at 12 months
Change in Disability2
Time frame: Change from baseline disability2 at 12 months
Change in Health
Time frame: Change from baseline health at 12 months
Change in Life satisfaction
Time frame: Change from baseline life satisfaction at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Derived from this study: PubMed 29631567Wiklund 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Björn Gerdle, MD, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT and Physical activity in people with Chronic Pain, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain intensity (time frame: Change from baseline pain intensity at 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02399644, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.