Chronic PainNCT02378025
Treating Chronic Pain in Gulf War Illness
A study testing Yoga Group and Pain Management Wellness Group in people with Chronic Pain and Gulf War Illness, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
The purpose of this study is to determine whether yoga is effective for the treatment of chronic pain in Gulf War Illness. Read more about this study
- Who is it for?
- Ages 42 to 85 years
- Conditions the study is for
- Chronic Pain, Gulf War Illness, Chronic Illness
- What is being tested?
- Yoga Group and Pain Management Wellness Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 42 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Served in the military in 1990-1991, regardless of deployment.
- History of chronic pain.
- Able to attend weekly visits at the study center for 10 weeks.
- If on a psychotropic medication, the regimen will be stable for at least 4 weeks, prior to entry in the study.
Who cannot join
- Participation in another clinical trial.
- Unable to visit the study center.
- Unable to stand or walk.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
Official title: A Multimodal Evaluation of the Comparative Efficacy of Yoga Versus a Patient Centered Support Group for Treating Chronic Pain in Gulf War Illness
The purpose of this study is to determine whether yoga is effective for the treatment of chronic pain in Gulf War Illness.
Read the detailed description
Background:
Many military personnel who participated in the Gulf War in 1990-1991 reported negative health consequences subsequent to their deployment. The most prevalent of these health consequences involves a triad of symptoms that include fatigue, pain and cognitive disturbances, commonly referred to as "Gulf War Illness" (GWI). No clear, unifying patho-physiological disease process or effective treatment has yet been identified for GWI. Results from a diverse spectrum of research studies support the view that veterans with GWI are medically ill, but the physiological abnormalities that contribute to their illness are not currently well understood nor sufficiently treated by conventional medicine. While the cause of GWI remains unknown, a potential link between GWI and autonomic nervous system (ANS) dysregulation has been suggested.
Yoga has been suggested to exert its therapeutic effects through adjusting imbalances in the ANS. In addition, yoga has been shown to be clinically effective in treating many of the physical symptoms typically found in GWI, including chronic pain and fatigue. As chronic pain is perhaps the most prevalent and debilitating symptom of GWI, we propose to target pain. Significantly for this application, no improvements in pain have yet been reported in any clinical trial involving GWI. Furthermore, no published studies have investigated yoga as an intervention in GWI.
Objectives:
The primary objective is to investigate yoga for the treatment of chronic pain in veterans with GWI. A secondary objective is to provide veterans with skills in yoga breathing, postures, and meditation that can be used to promote health and well-being.
Hypothesis 1 (primary):
- The subjective experience of pain, as measured by the Brief Pain Inventory-Short Form, will be reduced at end of treatment in the group given a 10-week yoga treatment program, compared to a pain support group (control).
- This effect will be sustained across time and will be found at the end of the 24-week post-treatment follow-up.
Hypothesis 2 (secondary):
Yoga will have a beneficial effect on general well-being; thus, compared to the control group, the yoga treatment group will show benefits across a broad range of measures, including quality of life, fatigue, and medication use.
Specific Aims:
- To assess the efficacy of yoga in reducing chronic pain and determine if the health-related benefits of yoga persist after termination of the treatment program.
- To obtain symptom-based outcome measures for veterans with GWI (before and after randomization) to assess pain, fatigue, physical functional status and quality of life.
Study Design:
The intervention to be tested is a 10-week yoga treatment program that has been specially designed for the treatment of chronic pain, as experienced by veterans with GWI. One hundred patients will be randomly assigned to one of two treatment groups: group yoga or a pain management wellness group (control). The control group has been carefully designed to control for many features of a yoga intervention. Patients in both groups will attend weekly classes for 10 weeks, followed by 6 months of follow up. Monitoring will include periodic measures of pain, fatigue, quality of life, and ANS function.
Impact:
Despite increasing demand from veterans for yoga and other forms of complementary and alternative treatments, the provision of yoga in veteran healthcare remains sparse. This is due, in large part, to a lack of randomized clinical trials capable of demonstrating the efficacy and safety of yoga for the treatment of conditions such as GWI. Such a demonstration would strengthen the case to offer yoga as a widely-available treatment for pain in GWI and would help promote yoga as part of integrative healthcare. This treatment trial is designed to begin to determine potential mechanisms of pain maintenance in GWI. If yoga leads to improvement in pain outcome, this would support performing a larger clinical trial of yoga for treating pain and other symptoms of GWI.
- Conditions
- Chronic Pain, Gulf War Illness, Chronic Illness
- Being tested
- Yoga Group, Pain Management Wellness Group
- Keywords
- Chronic Pain, Veterans, Gulf War Illness
- Medical subject headings
- Chronic Pain, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga GroupBehavioural
A 10-week yoga course designed to treat pain.
Pain Management Wellness GroupBehavioural
A 10-week behavioral therapy course designed to treat pain.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Group | Experimental | Postures, meditation, breathing exercises Receives: Behavioral: Yoga Group |
| Pain Management Wellness Group | Active comparator | Behavioral medicine Receives: Behavioral: Pain Management Wellness Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (Brief Pain Inventory - Short Form) - Pain Severity
Model - estimated change in the Pain Severity subscale of the Brief Pain Inventory - Short Form from baseline to end of treatment. The subscale's minimum score is 0; maximum is 10; more negative change scores indicate greater improvement from baseline to end of treatment
Measured: Week 10 minus Week 0
Pain (Brief Pain Inventory - Short Form) - Pain Interference
Model - estimated change in the Pain Interference subscale of the Brief Pain Inventory - Short Form from baseline to end of treatment. The subscale's minimum score is 0; maximum is 10; more negative change scores indicate greater improvement from baseline to end of treatment.
Measured: Week 10 minus Week 0
Secondary outcomes (4)
Fatigue (6-Minute Walk Test)
Increase from baseline to end of treatment in distance walked during 6-Minute Walk Test. Greater values indicate more increase and therefore a more positive outcome.
Measured: Week 0, Week 10
Change in Number of Participants Who Used Analgesic Medication
Change in number of participants who self-reported use of analgesic medication(s) from Week 0 to Week 10.
Measured: Week 0, Week 10
Change in Number of Participants Who Used Nonsteroidal Anti-inflammatory Drugs
Change in number of participants who self-reported use of Nonsteroidal Anti-inflammatory Drug(s) from Week 0 to Week 10.
Measured: Week 0, Week 10
Change in Number of Participants Who Used Opiate Medication
Change in number of participants who self-reported use of Opiate Medication(s) from Week 0 to Week 10.
Measured: Week 0, Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study start1 Jun 2015
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Peter Bayley, Palo Alto Veterans Institute for Research
- Investigators
- Peter Bayley, PhD, Principal investigator, VA Palo Alto Heath Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378025
- Sponsor's protocol ID
- BAY0001AGG
- Other IDs
- W81XWH-14-1-0615
- Status last verified
- May 2020
- First submitted
- 26 Feb 2015
- Last updated
- 11 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Allende S, Mathersul DC, Schulz-Heik JR, Avery TJ, Mahoney L, Bayley PJ. Yoga is effective for treating chronic pain in veterans with Gulf War Illness at long-term follow-up. BMC Complement Med Ther. 2023 Sep 13;23(1):319. doi: 10.1186/s12906-023-04145-y.
PubMed 37704984Mathersul DC, Dixit K, Avery TJ, Schulz-Heik RJ, Zeitzer JM, Mahoney LA, Cho RH, Bayley PJ. Heart rate and heart rate variability as outcomes and longitudinal moderators of treatment for pain across follow-up in Veterans with Gulf War illness. Life Sci. 2021 Jul 15;277:119604. doi: 10.1016/j.lfs.2021.119604. Epub 2021 May 11.
PubMed 33984356Bayley PJ, Schulz-Heik RJ, Cho R, Mathersul D, Collery L, Shankar K, Ashford JW, Jennings JS, Tang J, Wong MS, Avery TJ, Stanton MV, Meyer H, Friedman M, Kim S, Jo B, Younger J, Mathews B, Majmundar M, Mahoney L. Yoga is effective in treating symptoms of Gulf War illness: A randomized clinical trial. J Psychiatr Res. 2021 Nov;143:563-571. doi: 10.1016/j.jpsychires.2020.11.024. Epub 2020 Nov 11.
PubMed 33218747
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Evaluation of the Comparative Efficacy of Yoga Versus a Patient Centered Support Group for Treating Chronic Pain in Gulf War Illness
- ClinicalTrials.gov ID
- NCT02378025
- Acronym / sponsor ID
- BAY0001AGG
- Conditions
- Chronic Pain, Gulf War Illness, Chronic Illness
- Keywords
- Chronic Pain, Veterans, Gulf War Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Posted 11 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether yoga is effective for the treatment of chronic pain in Gulf War Illness.
Detailed description
Background:
Many military personnel who participated in the Gulf War in 1990-1991 reported negative health consequences subsequent to their deployment. The most prevalent of these health consequences involves a triad of symptoms that include fatigue, pain and cognitive disturbances, commonly referred to as "Gulf War Illness" (GWI). No clear, unifying patho-physiological disease process or effective treatment has yet been identified for GWI. Results from a diverse spectrum of research studies support the view that veterans with GWI are medically ill, but the physiological abnormalities that contribute to their illness are not currently well understood nor sufficiently treated by conventional medicine. While the cause of GWI remains unknown, a potential link between GWI and autonomic nervous system (ANS) dysregulation has been suggested.
Yoga has been suggested to exert its therapeutic effects through adjusting imbalances in the ANS. In addition, yoga has been shown to be clinically effective in treating many of the physical symptoms typically found in GWI, including chronic pain and fatigue. As chronic pain is perhaps the most prevalent and debilitating symptom of GWI, we propose to target pain. Significantly for this application, no improvements in pain have yet been reported in any clinical trial involving GWI. Furthermore, no published studies have investigated yoga as an intervention in GWI.
Objectives:
The primary objective is to investigate yoga for the treatment of chronic pain in veterans with GWI. A secondary objective is to provide veterans with skills in yoga breathing, postures, and meditation that can be used to promote health and well-being.
Hypothesis 1 (primary):
- The subjective experience of pain, as measured by the Brief Pain Inventory-Short Form, will be reduced at end of treatment in the group given a 10-week yoga treatment program, compared to a pain support group (control).
- This effect will be sustained across time and will be found at the end of the 24-week post-treatment follow-up.
Hypothesis 2 (secondary):
Yoga will have a beneficial effect on general well-being; thus, compared to the control group, the yoga treatment group will show benefits across a broad range of measures, including quality of life, fatigue, and medication use.
Specific Aims:
- To assess the efficacy of yoga in reducing chronic pain and determine if the health-related benefits of yoga persist after termination of the treatment program.
- To obtain symptom-based outcome measures for veterans with GWI (before and after randomization) to assess pain, fatigue, physical functional status and quality of life.
Study Design:
The intervention to be tested is a 10-week yoga treatment program that has been specially designed for the treatment of chronic pain, as experienced by veterans with GWI. One hundred patients will be randomly assigned to one of two treatment groups: group yoga or a pain management wellness group (control). The control group has been carefully designed to control for many features of a yoga intervention. Patients in both groups will attend weekly classes for 10 weeks, followed by 6 months of follow up. Monitoring will include periodic measures of pain, fatigue, quality of life, and ANS function.
Impact:
Despite increasing demand from veterans for yoga and other forms of complementary and alternative treatments, the provision of yoga in veteran healthcare remains sparse. This is due, in large part, to a lack of randomized clinical trials capable of demonstrating the efficacy and safety of yoga for the treatment of conditions such as GWI. Such a demonstration would strengthen the case to offer yoga as a widely-available treatment for pain in GWI and would help promote yoga as part of integrative healthcare. This treatment trial is designed to begin to determine potential mechanisms of pain maintenance in GWI. If yoga leads to improvement in pain outcome, this would support performing a larger clinical trial of yoga for treating pain and other symptoms of GWI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | Experimental | Behavioral: Yoga GroupPostures, meditation, breathing exercises |
| Pain Management Wellness Group | Active comparator | Behavioral: Pain Management Wellness GroupBehavioral medicine |
Who may qualify
- Ages
- 42 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Served in the military in 1990-1991, regardless of deployment.
- History of chronic pain.
- Able to attend weekly visits at the study center for 10 weeks.
- If on a psychotropic medication, the regimen will be stable for at least 4 weeks, prior to entry in the study.
Key exclusion criteria (3 listed)
- Participation in another clinical trial.
- Unable to visit the study center.
- Unable to stand or walk.
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 |
|---|---|---|
| Yoga GroupA 10-week yoga course designed to treat pain. | Behavioural | Yoga Group |
| Pain Management Wellness GroupA 10-week behavioral therapy course designed to treat pain. | Behavioural | Pain Management Wellness Group |
Primary outcome
Pain (Brief Pain Inventory - Short Form) - Pain Severity
Time frame: Week 10 minus Week 0
Model - estimated change in the Pain Severity subscale of the Brief Pain Inventory - Short Form from baseline to end of treatment. The subscale's minimum score is 0; maximum is 10; more negative change scores indicate greater improvement from baseline to end of treatment
Pain (Brief Pain Inventory - Short Form) - Pain Interference
Time frame: Week 10 minus Week 0
Model - estimated change in the Pain Interference subscale of the Brief Pain Inventory - Short Form from baseline to end of treatment. The subscale's minimum score is 0; maximum is 10; more negative change scores indicate greater improvement from baseline to end of treatment.
4 secondary outcomes
Fatigue (6-Minute Walk Test)
Time frame: Week 0, Week 10
Change in Number of Participants Who Used Analgesic Medication
Time frame: Week 0, Week 10
Change in Number of Participants Who Used Nonsteroidal Anti-inflammatory Drugs
Time frame: Week 0, Week 10
Change in Number of Participants Who Used Opiate Medication
Time frame: Week 0, Week 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37704984Allende S, Mathersul DC, Schulz-Heik JR, Avery TJ, Mahoney L, Bayley PJ. Yoga is effective for treating chronic pain in veterans with Gulf War Illness at long-term follow-up. BMC Complement Med Ther. 2023 Sep 13;23(1):319. doi: 10.1186/s12906-023-04145-y.
- Derived from this study: PubMed 33984356Mathersul DC, Dixit K, Avery TJ, Schulz-Heik RJ, Zeitzer JM, Mahoney LA, Cho RH, Bayley PJ. Heart rate and heart rate variability as outcomes and longitudinal moderators of treatment for pain across follow-up in Veterans with Gulf War illness. Life Sci. 2021 Jul 15;277:119604. doi: 10.1016/j.lfs.2021.119604. Epub 2021 May 11.
- Derived from this study: PubMed 33218747Bayley PJ, Schulz-Heik RJ, Cho R, Mathersul D, Collery L, Shankar K, Ashford JW, Jennings JS, Tang J, Wong MS, Avery TJ, Stanton MV, Meyer H, Friedman M, Kim S, Jo B, Younger J, Mathews B, Majmundar M, Mahoney L. Yoga is effective in treating symptoms of Gulf War illness: A randomized clinical trial. J Psychiatr Res. 2021 Nov;143:563-571. doi: 10.1016/j.jpsychires.2020.11.024. Epub 2020 Nov 11.
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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.
Peter Bayley, PhD principal investigator
VA Palo Alto Heath Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Group and Pain Management Wellness Group in people with Chronic Pain and Gulf War Illness, run by Palo Alto Veterans Institute for Research at 1 site in United States.
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 4 inclusion and 3 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 11 Jun 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain (Brief Pain Inventory - Short Form) - Pain Severity (time frame: Week 10 minus Week 0). The study lists 2 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 NCT02378025, which also lists 3 linked publications.
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 11 Jun 2020.