Chronic Neck PainGAPYOGANCT04296344
Group Acupuncture Therapy With Modified Yoga
A study testing Acupuncture Therapy Treatments and Yoga Therapy Sessions in people with Chronic Neck Pain and Chronic Low Back Pain, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial summary
Chronic pain is prevalent in the U.S., with impact on physical and psychological functioning as well as lost work productivity. Minority and lower socioeconomic populations have increased prevalence of chronic pain with less access to pain care and poorer outcomes. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Neck Pain, Chronic Low Back Pain, Osteoarthritis Pain
- What is being tested?
- Acupuncture Therapy Treatments and Yoga Therapy Sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Jan 2019to 11 Nov 2020
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 21 years of age or older
- Chronic pain (three months or more in duration) due to a qualifying diagnosis of back pain, neck pain, and/or osteoarthritis.
- Eligible patients must be receiving primary care at a participating IFH or Montefiore Medical Group site
- Participants must understand and be able to provide consent in English or Spanish
- Reliable contact phone numbers must be available to facilitate scheduling,
- Availability for up to 10 weekly consecutive treatments and
- Availability for follow-up data collection at 24 weeks
Who cannot join
- Receipt of acupuncture treatment or yoga instruction/therapy in the 6 months prior to recruitment
- Pregnancy
- Severe psychiatric problems as assessed by the study team (e.g., chronic interpersonal problems, cognitive impairment or active psychosis that is uncontrolled by medication that precludes the ability to provide informed consent or complete the survey instruments)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Institute For Family Health
New York, New York, 10035
Montefiore Family Health Center
The Bronx, New York, 10458
Williamsbridge Family Practice Center
The Bronx, New York, 10469
About this study
Official title: Group Acupuncture Therapy With Modified Yoga for Chronic Neck, Low Back and OA Pain in Safety Net Setting for an Underserved Population (GAPYOGA)
Chronic pain is prevalent in the U.S., with impact on physical and psychological functioning as well as lost work productivity. Minority and lower socioeconomic populations have increased prevalence of chronic pain with less access to pain care and poorer outcomes. Acupuncture therapy is effective in treating chronic pain conditions including chronic low back pain (cLBP), neck pain, shoulder pain and knee pain from osteoarthritis (OA). Acupuncture therapy, including group acupuncture, is feasible and effective, and specifically so for underserved and diverse populations at risk for health outcome disparities. Acupuncture therapy also encourages patient engagement and activation. As chronic pain improves there is a natural progression to want and need to increase activity and movement recovery. Diverse movement approaches are important both for improving range of motion, maintaining gains, strengthening and promoting patient engagement and activation. Yoga therapy is an active therapy with proven benefit in musculoskeletal pain disorders and pain associated disability. The aim of this pilot feasibility trial is to test the bundling of these two care options for chronic pain, to inform both the design for a larger randomized pragmatic effectiveness trial as well as implementation strategies across underserved settings.
Read the detailed description
The goal of this project is to assess the feasibility of a low-cost, integrative intervention for chronic pain that can be replicated and implemented in underserved medical settings across the U.S. Over the course of 18 months, the study team will recruit at least 150 outpatients with chronic pain from the Institute for Family Health (IFH) Family Medicine sites and Montefiore Medical Group sites, both Federally Qualified Health Centers (FQHCs). Treatment will consist of ten consecutive weekly group acupuncture therapy treatments. Yoga therapy treatments will start at week three and will consist of eight consecutive yoga therapy sessions that occur immediately following in a room adjacent to acupuncture therapy. Sessions are bundled to facilitate attendance that might be affected by two separate trips a week for participation. The primary outcome will be pain interference and pain intensity. Secondary outcomes will be pain free days, depression, functional status, patient activation, and pain medication utilization. These will be used during the pre-intervention phase, during which patients are receiving usual care only, and compared to the period after patients receive the combined acupuncture and yoga sessions. Data will be collected for 10 days before acupuncture and yoga therapy, and up to 24 weeks following the end of treatment.
The study will use a 'multiple settings across baseline' quasi-experimental design. This is a repeated measures design, and each study participant will have multiple pre- and post-measures. The multiple pre-measurement points allows the study team to document and monitor what may be variable patterns of pain pre-intervention. This design optimizes feasibility and acceptability to patients and participating health centers while still generating meaningful outcome data. Specifically, the study team has not proposed randomization within the practices, rather allowing sites to offer the intervention to all patients with target diagnoses who meet eligibility criteria. To collect pre-acupuncture assessments of pain, the study team will include a 10 day intake run-in period prior to the initial acupuncture session that ensures treatment within a time frame that is consistent with typical time to appointments for many consultations.
- Being tested
- Acupuncture Therapy Treatments, Yoga Therapy Sessions
- Keywords
- Acupuncture therapy, Yoga therapy, Integrative medicine, Chronic pain, Underserved, Safety net setting
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture Therapy TreatmentsOther
10 consecutive weekly group acupuncture therapy treatments
Yoga Therapy SessionsOther
8 consecutive yoga therapy sessions that occur immediately following in a room adjacent to acupuncture therapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants with chronic pain to receive acupuncture therapy treatments and yoga therapy sessions. Receives: Other: Acupuncture Therapy Treatments; Other: Yoga Therapy Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brief Pain Inventory: Short Form
The BPI is a nine-item measure which that asks patients to indicate how their pain influences function: select aspects of their everyday life including mood, walking, sleep and their ability to work over the past 24 hours, as well as the level and intensity of pain. This measure will be adapted for use by phone, modifying a question which asks participants to refer to a diagram of the body. total score from 0 to 10, with higher score indicating worse outcomes.
Measured: Baseline and Week 24
Secondary outcomes (7)
Change in Pain Free Days
Self-report measure to report the number of pain free days in the previous 2 weeks. This measure will be used pre- and post-intervention.
Measured: Baseline and Week 24
Change in Center for Epidemiological Studies - Depression Scale (CES-D)
This is a well-validated, 20-item measure of depressive symptoms. This will be used both at the initiation treatment interview and the end of the study. Full score from 0- 20, with higher score indicating more symptomology.
Measured: Baseline and Week 24
Change in Altarum Consumer Engagement (ACE)
A 12-item measure that assesses three domains of health engagement: commitment, informed choice, and navigation. The measure covers areas not included in other surveys and it is a good predictor of current health status, lifestyle health behaviors, medication adherence, and how likely it is that people will use tools to support their decisions. This measure will be adapted to include 8 of the 12 items on the questionnaire. Full scale from 0-100, higher score indicates higher consumer engagement.
Measured: Baseline and Week 24
Change in Patient-Reported Outcomes Measurement Information System (PROMIS 10)
A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults and children. 10-item patient-reported questionnaire. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Measured: Baseline and Week 24
Change in PROMIS Satisfaction with Participation in Social Roles (PROMIS-SF)
is a 14-item measure that is part of the PROMIS Social Function. The measure refers to social roles, such as work and family responsibilities, and more discretionary social activities, such as leisure activity and relationships with friends. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Measured: Baseline and Week 24
Change in Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC) is a single question 7-point categorical scale that captures a patient's experience of treatment at follow-up points, after all sessions are completed. Full score from 0-7, with higher score indicating more improvement.
Measured: Week 10 and Week 24
Change in Medication Utilization
Participants will be asked to report their use of pain medications over the prior one-week period.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start8 Jan 2019
- Primary completion11 Nov 2020
- Study completion11 Nov 2020
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 Neck PainStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- The Institute for Family Health, Albert Einstein College of Medicine, Maryland University of Integrative Health
- Responsible party
- Principal investigator, Raymond Teets, Icahn School of Medicine at Mount Sinai
- Investigators
- Raymond Teets, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296344
- Sponsor's protocol ID
- GCO 18-1240
- Other IDs
- 02855405
- Acronym
- GAPYOGA
- Status last verified
- Feb 2021
- First submitted
- 3 Mar 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Anderson BJ, Meissner P, Mah DM, Nielsen A, Moonaz S, McKee MD, Kligler B, Milanes M, Guerra H, Teets R. Barriers and Facilitators to Implementing Bundled Acupuncture and Yoga Therapy to Treat Chronic Pain in Community Healthcare Settings: A Feasibility Pilot. J Altern Complement Med. 2021 Jun;27(6):496-505. doi: 10.1089/acm.2020.0394. Epub 2021 Mar 15.
PubMed 33720749
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Acupuncture Therapy With Modified Yoga for Chronic Neck, Low Back and OA Pain in Safety Net Setting for an Underserved Population (GAPYOGA)
- ClinicalTrials.gov ID
- NCT04296344
- Acronym / sponsor ID
- GAPYOGA / GCO 18-1240
- Keywords
- Acupuncture therapy, Yoga therapy, Integrative medicine, Chronic pain, Underserved, Safety net setting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- The Institute for Family Health, Albert Einstein College of Medicine, Maryland University of Integrative Health
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 5 Mar 2020 (actual)
- 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.
Chronic pain is prevalent in the U.S., with impact on physical and psychological functioning as well as lost work productivity. Minority and lower socioeconomic populations have increased prevalence of chronic pain with less access to pain care and poorer outcomes. Acupuncture therapy is effective in treating chronic pain conditions including chronic low back pain (cLBP), neck pain, shoulder pain and knee pain from osteoarthritis (OA). Acupuncture therapy, including group acupuncture, is feasible and effective, and specifically so for underserved and diverse populations at risk for health outcome disparities. Acupuncture therapy also encourages patient engagement and activation. As chronic pain improves there is a natural progression to want and need to increase activity and movement recovery. Diverse movement approaches are important both for improving range of motion, maintaining gains, strengthening and promoting patient engagement and activation. Yoga therapy is an active therapy with proven benefit in musculoskeletal pain disorders and pain associated disability. The aim of this pilot feasibility trial is to test the bundling of these two care options for chronic pain, to inform both the design for a larger randomized pragmatic effectiveness trial as well as implementation strategies across underserved settings.
Detailed description
The goal of this project is to assess the feasibility of a low-cost, integrative intervention for chronic pain that can be replicated and implemented in underserved medical settings across the U.S. Over the course of 18 months, the study team will recruit at least 150 outpatients with chronic pain from the Institute for Family Health (IFH) Family Medicine sites and Montefiore Medical Group sites, both Federally Qualified Health Centers (FQHCs). Treatment will consist of ten consecutive weekly group acupuncture therapy treatments. Yoga therapy treatments will start at week three and will consist of eight consecutive yoga therapy sessions that occur immediately following in a room adjacent to acupuncture therapy. Sessions are bundled to facilitate attendance that might be affected by two separate trips a week for participation. The primary outcome will be pain interference and pain intensity. Secondary outcomes will be pain free days, depression, functional status, patient activation, and pain medication utilization. These will be used during the pre-intervention phase, during which patients are receiving usual care only, and compared to the period after patients receive the combined acupuncture and yoga sessions. Data will be collected for 10 days before acupuncture and yoga therapy, and up to 24 weeks following the end of treatment.
The study will use a 'multiple settings across baseline' quasi-experimental design. This is a repeated measures design, and each study participant will have multiple pre- and post-measures. The multiple pre-measurement points allows the study team to document and monitor what may be variable patterns of pain pre-intervention. This design optimizes feasibility and acceptability to patients and participating health centers while still generating meaningful outcome data. Specifically, the study team has not proposed randomization within the practices, rather allowing sites to offer the intervention to all patients with target diagnoses who meet eligibility criteria. To collect pre-acupuncture assessments of pain, the study team will include a 10 day intake run-in period prior to the initial acupuncture session that ensures treatment within a time frame that is consistent with typical time to appointments for many consultations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Acupuncture Therapy Treatments, Other: Yoga Therapy SessionsParticipants with chronic pain to receive acupuncture therapy treatments and yoga therapy sessions. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients 21 years of age or older
- Chronic pain (three months or more in duration) due to a qualifying diagnosis of back pain, neck pain, and/or osteoarthritis.
- Eligible patients must be receiving primary care at a participating IFH or Montefiore Medical Group site
- Participants must understand and be able to provide consent in English or Spanish
- Reliable contact phone numbers must be available to facilitate scheduling,
Key exclusion criteria (3 listed)
- Receipt of acupuncture treatment or yoga instruction/therapy in the 6 months prior to recruitment
- Pregnancy
- Severe psychiatric problems as assessed by the study team (e.g., chronic interpersonal problems, cognitive impairment or active psychosis that is uncontrolled by medication that precludes the ability to provide informed consent or complete the survey instruments)
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 |
|---|---|---|
| Acupuncture Therapy Treatments10 consecutive weekly group acupuncture therapy treatments | Other | Treatment |
| Yoga Therapy Sessions8 consecutive yoga therapy sessions that occur immediately following in a room adjacent to acupuncture therapy. | Other | Treatment |
Primary outcome
Change in Brief Pain Inventory: Short Form
Time frame: Baseline and Week 24
The BPI is a nine-item measure which that asks patients to indicate how their pain influences function: select aspects of their everyday life including mood, walking, sleep and their ability to work over the past 24 hours, as well as the level and intensity of pain. This measure will be adapted for use by phone, modifying a question which asks participants to refer to a diagram of the body. total score from 0 to 10, with higher score indicating worse outcomes.
7 secondary outcomes
Change in Pain Free Days
Time frame: Baseline and Week 24
Change in Center for Epidemiological Studies - Depression Scale (CES-D)
Time frame: Baseline and Week 24
Change in Altarum Consumer Engagement (ACE)
Time frame: Baseline and Week 24
Change in Patient-Reported Outcomes Measurement Information System (PROMIS 10)
Time frame: Baseline and Week 24
Change in PROMIS Satisfaction with Participation in Social Roles (PROMIS-SF)
Time frame: Baseline and Week 24
Change in Patient Global Impression of Change (PGIC)
Time frame: Week 10 and Week 24
Change in Medication Utilization
Time frame: Baseline and Week 24
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 3 Feb 2021.
- Derived from this study: PubMed 33720749Anderson BJ, Meissner P, Mah DM, Nielsen A, Moonaz S, McKee MD, Kligler B, Milanes M, Guerra H, Teets R. Barriers and Facilitators to Implementing Bundled Acupuncture and Yoga Therapy to Treat Chronic Pain in Community Healthcare Settings: A Feasibility Pilot. J Altern Complement Med. 2021 Jun;27(6):496-505. doi: 10.1089/acm.2020.0394. Epub 2021 Mar 15.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Raymond Teets, MD principal investigator
MOUNT SINAI HOSPITAL
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture Therapy Treatments and Yoga Therapy Sessions in people with Chronic Neck Pain and Chronic Low Back Pain, run by Icahn School of Medicine at Mount Sinai at 3 sites 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 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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 Brief Pain Inventory: Short Form (time frame: Baseline and Week 24). 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 NCT04296344, 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 3 Feb 2021.