Chronic PainNCT04074109
Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain
A study testing Teleyoga and In-person yoga in people with Chronic Pain and Musculoskeletal Pain, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
This feasibility study will evaluate yoga as a treatment for chronic musculoskeletal pain. The experimental treatment is yoga delivered via a tablet computer to participants at home ("teleyoga"). First, the investigators will develop a suitable protocol for teleyoga. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Musculoskeletal Pain
- What is being tested?
- Teleyoga and In-person yoga
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2019to 17 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran
- Medical clearance for participation by VA primary care provider
- Diagnosis of musculoskeletal pain > 6 months
- Minimum pain intensity of 4 at screening on 0-10 scale
- Any psychotropic treatments stable for at least 4 weeks before study
- English literacy
- Wireless Internet connection at home
Who cannot join
- Current participation in another clinical trial
- Back surgery within the last 12 months
- Back pain related to a specific underlying cause, disease, or condition
- Baseline pain <4 or >9 on 0-10 scale
- Unstable, serious coexisting medical illness
- Unstable, serious coexisting mental illness
- Attended or practiced yoga ≥1 time in the past 12 months
- Active current suicidal plan or intent
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
This feasibility study will evaluate yoga as a treatment for chronic musculoskeletal pain. The experimental treatment is yoga delivered via a tablet computer to participants at home ("teleyoga"). First, the investigators will develop a suitable protocol for teleyoga. Second, the investigators will demonstrate the feasibility of conducting a randomized controlled trial involving randomization to teleyoga or in-person yoga groups.
Read the detailed description
The first phase of the study is not randomized. In this phase, the first group of participants (n=10) will all participate in a tele-yoga class using an iPad loaned to them by the study. They will attend this treatment session from the comfort of their home or a location of their choice. Yoga treatment will last 12 weeks. At the end of treatment, veterans will provide feedback by completing a satisfaction questionnaire to rate various aspects of the teleyoga (e.g. technical challenges, ability to perform yoga through the video-conferencing platform, problems that occurred, and recommendations to improve the class, etc). The teleyoga protocol will be modified on the basis of this feedback and will be tested on a second group of participants (n=10). The second phase of the study will involve randomization of a further group of participants (n=30) to either the teleyoga developed in phase one, or in-person yoga.
- Conditions
- Chronic Pain, Musculoskeletal Pain
- Being tested
- Teleyoga, In-person yoga
- Keywords
- telehealth, yoga
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleyogaCombination product
the yoga protocol will be delivered via a tablet computer to groups of participants
In-person yogaBehavioural
the yoga protocol will be delivered by a yoga instructor in the room to group of participants
| Study group | Role | What they receive |
|---|---|---|
| Teleyoga | Experimental | group will receive instruction via computer tablet Receives: Combination Product: Teleyoga |
| In-person yoga | Active comparator | group will receive instruction in-person Receives: Behavioral: In-person yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-Dimensional Treatment Satisfaction Measure
A participant satisfaction measure [score range: 0 to 4]. The higher the value, the greater the treatment satisfaction
Measured: after 12 weeks of treatment
Adherence to the Treatment Protocol
% of randomized patients who attend ≥65% of treatment sessions
Measured: during 12 weeks of treatment
Attrition
number of randomized patients who drop out of treatment
Measured: during 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start6 Dec 2019
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
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 (2)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
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Peter Bayley, Palo Alto Veterans Institute for Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074109
- Sponsor's protocol ID
- BAY0006AGG
- Other IDs
- R34AT010364
- Status last verified
- Mar 2023
- First submitted
- 5 Aug 2019
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mahoney L, Pahade S, Mahoney H, Fitz K, Keaney A, Parker-Bridges K, Francisco JM, Lau A, Hitching R, Walker B, Gupta A, Jo B, Lohnberg JA, Clark JD, Bayley PJ. Randomized feasibility trial of tele-yoga versus in-person yoga for treating chronic musculoskeletal pain in veterans. BMC Complement Med Ther. 2026 Mar 17;26(1):153. doi: 10.1186/s12906-026-05345-y.
PubMed 41845334Mahoney L, Pahade S, Mahoney H, Fitz K, Keaney A, Parker-Bridges K, Francisco JM, Lau A, Hitching R, Walker B, Gupta A, Jo B, Lohnberg JA, Clark JD, Bayley PJ. Randomized Feasibility Trial of Teleyoga versus In-Person Yoga for Treating Chronic Musculoskeletal Pain in Veterans. Res Sq [Preprint]. 2025 Jun 23:rs.3.rs-6265068. doi: 10.21203/rs.3.rs-6265068/v1.
PubMed 40678237
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain
- ClinicalTrials.gov ID
- NCT04074109
- Acronym / sponsor ID
- BAY0006AGG
- Conditions
- Chronic Pain, Musculoskeletal Pain
- Keywords
- telehealth, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 29 Aug 2019 (actual)
- Results
- Posted 23 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This feasibility study will evaluate yoga as a treatment for chronic musculoskeletal pain. The experimental treatment is yoga delivered via a tablet computer to participants at home ("teleyoga"). First, the investigators will develop a suitable protocol for teleyoga. Second, the investigators will demonstrate the feasibility of conducting a randomized controlled trial involving randomization to teleyoga or in-person yoga groups.
Detailed description
The first phase of the study is not randomized. In this phase, the first group of participants (n=10) will all participate in a tele-yoga class using an iPad loaned to them by the study. They will attend this treatment session from the comfort of their home or a location of their choice. Yoga treatment will last 12 weeks. At the end of treatment, veterans will provide feedback by completing a satisfaction questionnaire to rate various aspects of the teleyoga (e.g. technical challenges, ability to perform yoga through the video-conferencing platform, problems that occurred, and recommendations to improve the class, etc). The teleyoga protocol will be modified on the basis of this feedback and will be tested on a second group of participants (n=10). The second phase of the study will involve randomization of a further group of participants (n=30) to either the teleyoga developed in phase one, or in-person yoga.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Teleyoga | Experimental | Combination Product: Teleyogagroup will receive instruction via computer tablet |
| In-person yoga | Active comparator | Behavioral: In-person yogagroup will receive instruction in-person |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Veteran
- Medical clearance for participation by VA primary care provider
- Diagnosis of musculoskeletal pain > 6 months
- Minimum pain intensity of 4 at screening on 0-10 scale
- Any psychotropic treatments stable for at least 4 weeks before study
Key exclusion criteria (8 listed)
- Current participation in another clinical trial
- Back surgery within the last 12 months
- Back pain related to a specific underlying cause, disease, or condition
- Baseline pain <4 or >9 on 0-10 scale
- Unstable, serious coexisting medical illness
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 |
|---|---|---|
| Teleyogathe yoga protocol will be delivered via a tablet computer to groups of participants | Combination product | Teleyoga |
| In-person yogathe yoga protocol will be delivered by a yoga instructor in the room to group of participants | Behavioural | In-person yoga |
Primary outcome
Multi-Dimensional Treatment Satisfaction Measure
Time frame: after 12 weeks of treatment
A participant satisfaction measure [score range: 0 to 4]. The higher the value, the greater the treatment satisfaction
Adherence to the Treatment Protocol
Time frame: during 12 weeks of treatment
% of randomized patients who attend ≥65% of treatment sessions
Attrition
Time frame: during 12 weeks of treatment
number of randomized patients who drop out of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41845334Mahoney L, Pahade S, Mahoney H, Fitz K, Keaney A, Parker-Bridges K, Francisco JM, Lau A, Hitching R, Walker B, Gupta A, Jo B, Lohnberg JA, Clark JD, Bayley PJ. Randomized feasibility trial of tele-yoga versus in-person yoga for treating chronic musculoskeletal pain in veterans. BMC Complement Med Ther. 2026 Mar 17;26(1):153. doi: 10.1186/s12906-026-05345-y.
- Derived from this study: PubMed 40678237Mahoney L, Pahade S, Mahoney H, Fitz K, Keaney A, Parker-Bridges K, Francisco JM, Lau A, Hitching R, Walker B, Gupta A, Jo B, Lohnberg JA, Clark JD, Bayley PJ. Randomized Feasibility Trial of Teleyoga versus In-Person Yoga for Treating Chronic Musculoskeletal Pain in Veterans. Res Sq [Preprint]. 2025 Jun 23:rs.3.rs-6265068. doi: 10.21203/rs.3.rs-6265068/v1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleyoga and In-person yoga in people with Chronic Pain and Musculoskeletal Pain, 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 7 inclusion and 8 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 18 Apr 2023. 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 23 Mar 2023). 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?
Multi-Dimensional Treatment Satisfaction Measure (time frame: after 12 weeks of treatment). The study lists 3 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 NCT04074109, which also lists 2 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 18 Apr 2023.