Chronic PainGAINNCT07909473
Group Acupuncture for Pain
A study testing Group Acupuncture Intervention in people with Chronic Pain, run by Duke University at 1 site in United States.
Trial summary
The goal of this study is to learn if group acupuncture is acceptable and feasible as a treatment for chronic pain in adults living in rural North Carolina, with the aim of improving access to equitable pain care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Group Acupuncture Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2024to 28 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years and older
- Experience chronic pain as defined as a response of "most days" or "every day" to the question, "In the past 3 months, how often have you had pain,"
- Ability to speak/understand English
Who cannot join
- Self-report of being currently pregnant
- Show signs of cognitive impairment, including evidence of drug, medication, or alcohol intoxication, that would prevent comprehension of consent and/or is contraindicated when receiving acupuncture (study staff and/or acupuncturists will assess for signs such as orientation to time and place, slurred speech, incoordination, impairment in attention or memory, stupor or drowsiness)
- Unwillingness to attend acupuncture sessions
Trial locations and contacts
1 site in 1 country.
United States1 site
Mebane Historical Museum
Mebane, North Carolina, 27302
About this study
Official title: Group Acupuncture for Improved Pain Relief in Rural Communities
The goal of this study is to learn if group acupuncture is acceptable and feasible as a treatment for chronic pain in adults living in rural North Carolina, with the aim of improving access to equitable pain care.
The main questions it aims to answer are:
Read more
Is group acupuncture acceptable (measured by a questionnaire and semi-structured interviews), feasible (measured by recruitment and retention rates), and delivered with fidelity (measured by the proportion of acupuncture sessions attended) among adults with chronic pain in rural North Carolina (Phase 2)?
Adults with chronic pain will:
- Attend up to 10 group acupuncture sessions over a 6-week period
- Complete a questionnaire about the acceptability of the intervention; a subset of participants will complete qualitative acceptability interviews
- Complete self-report measures of pain, anxiety, depression, sleep, fatigue, and quality of life
- Conditions
- Chronic Pain
- Being tested
- Group Acupuncture Intervention
- Keywords
- chronic pain, acupuncture
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Acupuncture InterventionOther
Enrolled participants will receive 10 acupuncture treatments over 6 weeks from licensed acupuncturists in a community group setting. Appointments will be staggered every 15-20 minutes, with participants seated comfortably alongside no more than four others. Using a pragmatic approach within North Carolina licensing standards, the acupuncturist will select distal/peripheral points based on assessment and diagnosis. Needling may involve the head, neck, arms, legs, hands, and feet; trunk points will not be used to maintain modesty. Sterile, disposable needles will remain in place for approximately 20-30 minutes. Electroacupuncture will not be used. For each participant and session, the acupuncturist will document the assessment, points needled, needle-retention time, and any adverse effects.
| Study group | Role | What they receive |
|---|---|---|
| Group Acupuncture | Experimental | All participants will receive 10 total acupuncture treatments delivered over 6 weeks by a licensed acupuncturist. Receives: Other: Group Acupuncture Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability
We assessed acceptability using the Theoretical Framework of Acceptability (TFA) Questionnaire. 7 TFA constructs are assessed, along with general acceptability items scores. Total score max = 35, with higher scores indicating higher acceptability of healthcare intervention.
Measured: At completion of study (6 weeks)
Feasibility of Enrollment
we will calculate the proportion of people who were approached for study participation and enrolled
Measured: Duration of recruitment period, up to approximately 16 months
Feasibility of Data Collection/Retention
We will calculate the percentage of participants who completed the surveys at each data collection time point (baseline, 3 weeks, 6 weeks) compared to those that did not.
Measured: From enrollment to completion of study at 6 weeks
Intervention Fidelity
Reported as the proportion (%) of acupuncture sessions attended (out of 10).
Measured: Duration of recruitment period, up to approximately 16 months
Intervention Acceptability Qualitative Interviews
Interviews were conducted on a subset of participants and included questions assessing participant experiences with the intervention, perceived effectiveness of the intervention, and overall acceptability of the intervention. All interviews were transcribed verbatim, and the transcripts served as the data source.
Measured: At completion of study (6 weeks)
Secondary outcomes (12)
Pain Impact
PEG Scale Assessing Pain Intensity and Interference (Pain, Enjoyment, General Activity). Score is calculated by adding the scores of its three questions and dividing the total by three to get an average score from 0 to 10.
Measured: Baseline, 3 weeks, 6 week data collection timepoints
Pain Location
Pain location (selected on body image); location \& number of pain locations summarized based on participant selection on body map image.
Measured: Baseline, 3 weeks, 6 weeks
Neuropathic Pain
PROMIS Neuropathic Pain Quality. T-score generated, with scores ≥ 50 suggesting a likely or prominent neuropathic pain quality phenotype
Measured: Baseline & 6 weeks data collection timepoints
Nociceptive Pain
PROMIS Nociceptive Pain questionnaire. T-score generate, with a score >50 suggesting nociceptive pain involvement.
Measured: Baseline and 6-week data collection timepoint
Pain Self-Efficacy
Pain Self-Efficacy Questionnaire. Scored by adding the numerical ratings of all 10 items, resulting in a total score from 0 to 60. Higher scores indicate greater pain self-efficacy.
Measured: Baseline & 6 week data collection timepoint
Pain Concerns
UW Concerns About Pain 2-item short-form questionnaire. T-score generated, with higher T-score representing higher levels of pain catastrophizing.
Measured: Baseline & 6-week data collection timepoint
Anxiety
PROMIS Anxiety Short Form (4-item). Scoring using T-score, with higher scores indicating higher levels of symptoms.
Measured: Baseline, 3-week, and 6-week data collection timepoint.
Depressive Symptoms
PROMIS Depressive Symptoms Short Form (4-item). Scoring using T-score, with higher scores indicating higher levels/burden of symptoms.
Measured: Baseline, 3-week, and 6-week data collection timepoints
Sleep Disturbances
PROMIS SLeep Disturbances Short-Form (4-item). Scoring using T-score, with higher scores indicating higher severity of sleep disturbance.
Measured: Baseline, 3-week, and 6-week data collection timepoint
Fatigue
PROMIS Fatigue Short Form (4-item). Scoring using T-score, with higher scores indicating higher levels/burden of fatigue.
Measured: Baseline, 3-week, and 6-week data collection timepoint.
Global Physical Health
PROMIS Global Health - Physical 2-item form. Scoring using T-score, with higher scores indicating better physical health.
Measured: Baseline, 3-week, & 6-week data collection timepoints.
Current Pain Medication Use
Assesses if participant is taking medications for pain. If so, questions around the frequency and type of pain medicines an individual is taking.
Measured: Baseline, 3-week, & 6-week data collection timepoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start12 Jun 2024
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Duke 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909473
- Sponsor's protocol ID
- Pro00114534
- Other IDs
- GBMF9048
- Acronym
- GAIN
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Acupuncture for Improved Pain Relief in Rural Communities
- ClinicalTrials.gov ID
- NCT07909473
- Acronym / sponsor ID
- GAIN / Pro00114534
- Conditions
- Chronic Pain
- Keywords
- chronic pain, acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 2 Nov 2026 (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.
The goal of this study is to learn if group acupuncture is acceptable and feasible as a treatment for chronic pain in adults living in rural North Carolina, with the aim of improving access to equitable pain care.
The main questions it aims to answer are:
Is group acupuncture acceptable (measured by a questionnaire and semi-structured interviews), feasible (measured by recruitment and retention rates), and delivered with fidelity (measured by the proportion of acupuncture sessions attended) among adults with chronic pain in rural North Carolina (Phase 2)?
Adults with chronic pain will:
- Attend up to 10 group acupuncture sessions over a 6-week period
- Complete a questionnaire about the acceptability of the intervention; a subset of participants will complete qualitative acceptability interviews
- Complete self-report measures of pain, anxiety, depression, sleep, fatigue, and quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Acupuncture | Experimental | Other: Group Acupuncture InterventionAll participants will receive 10 total acupuncture treatments delivered over 6 weeks by a licensed acupuncturist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years and older
- Experience chronic pain as defined as a response of "most days" or "every day" to the question, "In the past 3 months, how often have you had pain,"
- Ability to speak/understand English
Key exclusion criteria (3 listed)
- Self-report of being currently pregnant
- Show signs of cognitive impairment, including evidence of drug, medication, or alcohol intoxication, that would prevent comprehension of consent and/or is contraindicated when receiving acupuncture (study staff and/or acupuncturists will assess for signs such as orientation to time and place, slurred speech, incoordination, impairment in attention or memory, stupor or drowsiness)
- Unwillingness to attend acupuncture sessions
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 |
|---|---|---|
| Group Acupuncture InterventionEnrolled participants will receive 10 acupuncture treatments over 6 weeks from licensed acupuncturists in a community group setting. Appointments will be staggered every 15-20 minutes, with participants seated comfortably alongside no more than four others. Using a pragmatic approach within North Carolina licensing standards, the acupuncturist will select distal/peripheral points based on assessment and diagnosis. Needling may involve the head, neck, arms, legs, hands, and feet; trunk points will not be used to maintain modesty. Sterile, disposable needles will remain in place for approximately 20-30 minutes. Electroacupuncture will not be used. For each participant and session, the acupuncturist will document the assessment, points needled, needle-retention time, and any adverse effects. | Other | Group Acupuncture |
Primary outcome
Intervention Acceptability
Time frame: At completion of study (6 weeks)
We assessed acceptability using the Theoretical Framework of Acceptability (TFA) Questionnaire. 7 TFA constructs are assessed, along with general acceptability items scores. Total score max = 35, with higher scores indicating higher acceptability of healthcare intervention.
Feasibility of Enrollment
Time frame: Duration of recruitment period, up to approximately 16 months
we will calculate the proportion of people who were approached for study participation and enrolled
Feasibility of Data Collection/Retention
Time frame: From enrollment to completion of study at 6 weeks
We will calculate the percentage of participants who completed the surveys at each data collection time point (baseline, 3 weeks, 6 weeks) compared to those that did not.
Intervention Fidelity
Time frame: Duration of recruitment period, up to approximately 16 months
Reported as the proportion (%) of acupuncture sessions attended (out of 10).
Intervention Acceptability Qualitative Interviews
Time frame: At completion of study (6 weeks)
Interviews were conducted on a subset of participants and included questions assessing participant experiences with the intervention, perceived effectiveness of the intervention, and overall acceptability of the intervention. All interviews were transcribed verbatim, and the transcripts served as the data source.
12 secondary outcomes
Pain Impact
Time frame: Baseline, 3 weeks, 6 week data collection timepoints
Pain Location
Time frame: Baseline, 3 weeks, 6 weeks
Neuropathic Pain
Time frame: Baseline & 6 weeks data collection timepoints
Nociceptive Pain
Time frame: Baseline and 6-week data collection timepoint
Pain Self-Efficacy
Time frame: Baseline & 6 week data collection timepoint
Pain Concerns
Time frame: Baseline & 6-week data collection timepoint
Anxiety
Time frame: Baseline, 3-week, and 6-week data collection timepoint.
Depressive Symptoms
Time frame: Baseline, 3-week, and 6-week data collection timepoints
Sleep Disturbances
Time frame: Baseline, 3-week, and 6-week data collection timepoint
Fatigue
Time frame: Baseline, 3-week, and 6-week data collection timepoint.
Global Physical Health
Time frame: Baseline, 3-week, & 6-week data collection timepoints.
Current Pain Medication Use
Time frame: Baseline, 3-week, & 6-week data collection timepoint
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 2 Nov 2026.
- 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.
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 Group Acupuncture Intervention in people with Chronic Pain, run by Duke 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 3 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 2 Nov 2026. 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?
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?
Intervention Acceptability (time frame: At completion of study (6 weeks)). 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?
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 2 Nov 2026.