Chronic PainYoPainNCT03010878
Yoga and Occupational Therapy to Improve Pain
A study testing Yoga and Self-management in people with Chronic Pain, run by Colorado State University at 1 site in United States.
Trial summary
This was a randomized control trial of a yoga and self-management intervention for individuals with chronic pain. Participants were assigned to either a wait-list control group (self-management only), or a yoga intervention (self-management and yoga). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Yoga and Self-management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- greater than 18 years of age
- Individual with self-reported pain for over six months
- attending outpatient pain clinic
- ability to attend yoga classes
- ability to complete assessments
- ability to provide informed consent
Who cannot join
- consistent yoga practice over the past year
- self-reported exercise restrictions
- serious and recent medical procedures or conditions without doctor's note
- high risk pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Health Fort Collins Family Medicine Residency Program Pain Management Clinic
Fort Collins, Colorado, 80524
About this study
This was a randomized control trial of a yoga and self-management intervention for individuals with chronic pain. Participants were assigned to either a wait-list control group (self-management only), or a yoga intervention (self-management and yoga). Self-management education session occurred monthly within the community. Group yoga intervention was delivered two times a week with a specifically designed program that was progressively more difficult. Assessments were then administered pre and post intervention, and a semi-structured interview was completed following the intervention. Quantitative and qualitative data were then compared between groups.
Read the detailed description
This was a randomized control trial completed with two specific aims.
Aim 1: To assess the feasibility of completing a group yoga intervention in conjunction with an ongoing self-management education for people with chronic pain.
Aim 2: To explore the preliminary efficacy of a group yoga intervention in people with chronic pain. The key variables of interest were pain interference, functional performance, balance, strength, mobility, and quality of life (QoL)
- Conditions
- Chronic Pain
- Being tested
- Yoga, Self-management
- Keywords
- yoga, chronic pain, occupational therapy, self-management
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
The yoga intervention group addressed pain as a primary variable and balance as a secondary variable and how to best manage these symptoms in the clinic and community.
Yoga was delivered in sitting, standing, and floor postures
Self-managementOther
The self-management education group was provide once a month through University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. The program consisted of lifestyle variations, accountability, modifications, and strategies to management pain in daily life.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Arm | Experimental | Yoga administered twice a week for 8 weeks. Self-management education sessions administered once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic (Pain Clinic). Yoga interventions were administered twice a week at the Pain Clinic. Receives: Other: Yoga; Other: Self-management |
| Wait-list Control Arm | Experimental | Participants received only self-management intervention, which is provided once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. Receives: Other: Self-management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory--Short Form
The Brief Pain Inventory (Short Form) is a 9 item self-report questionnaire designed to assess general pain. Minimum 0 - Maximum 10 (higher score is indicated worse severity and interference with everyday life).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startAug 2015
- Primary completionMay 2016
- Study completionDec 2016
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 (1)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
- Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arlene Schmid, Colorado State University
- Investigators
- Arlene Schmid, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010878
- Sponsor's protocol ID
- 15.6017H
- Acronym
- YoPain
- Status last verified
- Jun 2025
- First submitted
- 29 Dec 2016
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Schmid AA, Atler KE, Malcolm MP, Grimm LA, Klinedinst TC, Marchant DR, Marchant TP, Portz JD. Yoga improves quality of life and fall risk-factors in a sample of people with chronic pain and Type 2 Diabetes. Complement Ther Clin Pract. 2018 May;31:369-373. doi: 10.1016/j.ctcp.2018.01.003. Epub 2018 Feb 15.
PubMed 29526474
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga and Occupational Therapy to Improve Pain
- ClinicalTrials.gov ID
- NCT03010878
- Acronym / sponsor ID
- YoPain / 15.6017H
- Conditions
- Chronic Pain
- Keywords
- yoga, chronic pain, occupational therapy, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a randomized control trial of a yoga and self-management intervention for individuals with chronic pain. Participants were assigned to either a wait-list control group (self-management only), or a yoga intervention (self-management and yoga). Self-management education session occurred monthly within the community. Group yoga intervention was delivered two times a week with a specifically designed program that was progressively more difficult. Assessments were then administered pre and post intervention, and a semi-structured interview was completed following the intervention. Quantitative and qualitative data were then compared between groups.
Detailed description
This was a randomized control trial completed with two specific aims.
Aim 1: To assess the feasibility of completing a group yoga intervention in conjunction with an ongoing self-management education for people with chronic pain.
Aim 2: To explore the preliminary efficacy of a group yoga intervention in people with chronic pain. The key variables of interest were pain interference, functional performance, balance, strength, mobility, and quality of life (QoL)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Arm | Experimental | Other: Yoga, Other: Self-managementYoga administered twice a week for 8 weeks. Self-management education sessions administered once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic (Pain Clinic). Yoga interventions were administered twice a week at the Pain Clinic. |
| Wait-list Control Arm | Experimental | Other: Self-managementParticipants received only self-management intervention, which is provided once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- greater than 18 years of age
- Individual with self-reported pain for over six months
- attending outpatient pain clinic
- ability to attend yoga classes
- ability to complete assessments
Key exclusion criteria (4 listed)
- consistent yoga practice over the past year
- self-reported exercise restrictions
- serious and recent medical procedures or conditions without doctor's note
- high risk pregnancy
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 |
|---|---|---|
| YogaThe yoga intervention group addressed pain as a primary variable and balance as a secondary variable and how to best manage these symptoms in the clinic and community. Yoga was delivered in sitting, standing, and floor postures | Other | Yoga Arm |
| Self-managementThe self-management education group was provide once a month through University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. The program consisted of lifestyle variations, accountability, modifications, and strategies to management pain in daily life. | Other | Wait-list Control Arm, Yoga Arm |
Primary outcome
Brief Pain Inventory--Short Form
Time frame: 8 weeks
The Brief Pain Inventory (Short Form) is a 9 item self-report questionnaire designed to assess general pain. Minimum 0 - Maximum 10 (higher score is indicated worse severity and interference with everyday life).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29526474Schmid AA, Atler KE, Malcolm MP, Grimm LA, Klinedinst TC, Marchant DR, Marchant TP, Portz JD. Yoga improves quality of life and fall risk-factors in a sample of people with chronic pain and Type 2 Diabetes. Complement Ther Clin Pract. 2018 May;31:369-373. doi: 10.1016/j.ctcp.2018.01.003. Epub 2018 Feb 15.
- Individual participant dataSharing planned: No
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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.
Arlene Schmid, PhD principal investigator
Colorado State 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 Yoga and Self-management in people with Chronic Pain, run by Colorado State University 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 6 inclusion and 4 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 6 Jun 2025. 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 6 Jun 2025). 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?
Brief Pain Inventory--Short Form (time frame: 8 weeks). 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 NCT03010878, 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 6 Jun 2025.