PainGAPNCT02328586
Group Acupuncture for Pain
A study testing Group Acupuncture in people with Pain, run by Beth Israel Medical Center at 1 site in United States.
Trial summary
This research project will test the feasibility and effectiveness of group acupuncture for the treatment of musculoskeletal pain (back pain, shoulder pain, neck pain and/or osteoarthritis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Group Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Oct 2016
- 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
- Patients 18 years of age or older, who understand English, are experiencing chronic musculoskeletal pain for three months or more and have not received acupuncture therapy in the past 3 months
Who cannot join
- Exclusion criteria will also include patients who have 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
1 site in 1 country.
United States1 site
The Center for Health and Healing
New York, New York, 10016
About this study
This research project will test the feasibility and effectiveness of group acupuncture for the treatment of musculoskeletal pain (back pain, shoulder pain, neck pain and/or osteoarthritis).
Read the detailed description
This research project will test the feasibility and effectiveness of group acupuncture for the treatment of musculoskeletal pain (back pain, shoulder pain, neck pain and/or osteoarthritis). Patients 18 years of age or older, who understand English, are experiencing chronic musculoskeletal pain for three months or more and have not received acupuncture therapy in the past 3 months will be invited to participate. We will recruit 120 outpatients with chronic pain from Mount Sinai Beth Israel's (MSBI) Family Medicine and other primary care practices. Referrals will be through primary care providers or by patient self-referral. The goal of this project is to develop a low-cost, effective integrative intervention for chronic pain which can be replicated in underserved settings across the U.S. The physician in charge of this study is Benjamin Kligler, M.D., M.P.H.
Eligible participants will be scheduled for a face-to-face interview, at which time consent will be obtained and baseline measures will be collected. Baseline measures include collecting demographic data and information on depression, pain/pain free days and medication use.
To follow, a 4-week run-in period where usual care is delivered will be held to establish baseline pain levels. During this time, participants will be contacted at 2-week intervals to complete a brief pain assessment. If a waiting list becomes necessary, delay may become longer.
Participants will then be invited to participate in an 8-week, group-based acupuncture treatment intervention delivered by a licensed acupuncturist. The group will meet weekly for 8 consecutive weeks, each session lasting about 75 minutes held at the Center for Health and Healing located at 245 Fifth Ave in Manhattan. Sessions will be held during evening and weekend hours to facilitate scheduling.
We will collect information on pain, pain symptoms, mood, function and analgesic use at 1, 8, 12 and 24 week(s) following the beginning of the intervention. We will collect this information in-person or by telephone as preferred by the participant. Participants will not receive an incentive to attend group sessions but will receive incentives at enrollment and for completing research interviews at 12 and 24 weeks following treatment intervention ($20 at each of these three time points).
While subject records are confidential, there may be loss of confidentiality due to the group acupuncture setting. Intervention risks are low: Acupuncture needles are pre-sterilized and inserted once only and then properly discarded. Acupuncture therapy is safe with a 'relative' risk that is low. The risks associated with providing protected health information (PHI) will be minimized by assigning a unique participant identification code (ID number) that will be used to identify all data reported for each participant. The study staff will store all PHI in a secure and protected site at the Center for Health and Healing. The study results will be stored in a locked cabinet and any study information stored in a computer will be password protected. Only the study staff will have access to the study results.
Subjects will be reminded of the elements of participation.
- Conditions
- Pain
- Being tested
- Group Acupuncture
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AcupunctureOther
| Study group | Role | What they receive |
|---|---|---|
| Group Acupuncture | Experimental | Participants will then be invited to participate in an 8-week, group-based acupuncture treatment intervention delivered by a licensed acupuncturist. The group will meet weekly for 8 consecutive weeks, each session lasting about 75 minutes. Receives: Other: Group Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain symptoms
We will collect information on pain, pain symptoms, and analgesic use at 1, 8, 12 and 24 week(s) following the beginning of the intervention. We will collect this information in-person or by telephone as preferred by the participant.
Measured: 24 weeks
Change in mood
We will collect information on mood at 1, 8, 12 and 24 week(s) following the beginning of the intervention. These measures will be collected by the use of validated tools which include scales and questionnaire such as BPI, CES-D and PGIC. We will track and see if our study interventions impact participants' mood
Measured: up to 24 weeks
Change in analgesic use
We will collect information on pain, pain symptoms, and analgesic use at 1, 8, 12 and 24 week(s) following the beginning of the intervention. We will collect this information in-person or by telephone as preferred by the participant.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Kligler, MD, Principal investigator, Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328586
- Sponsor's protocol ID
- 070-14
- Acronym
- GAP
- Status last verified
- Nov 2016
- First submitted
- 3 Jul 2014
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Acupuncture for Pain
- ClinicalTrials.gov ID
- NCT02328586
- Acronym / sponsor ID
- GAP / 070-14
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 31 Dec 2014 (estimated)
- 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.
This research project will test the feasibility and effectiveness of group acupuncture for the treatment of musculoskeletal pain (back pain, shoulder pain, neck pain and/or osteoarthritis).
Detailed description
This research project will test the feasibility and effectiveness of group acupuncture for the treatment of musculoskeletal pain (back pain, shoulder pain, neck pain and/or osteoarthritis). Patients 18 years of age or older, who understand English, are experiencing chronic musculoskeletal pain for three months or more and have not received acupuncture therapy in the past 3 months will be invited to participate. We will recruit 120 outpatients with chronic pain from Mount Sinai Beth Israel's (MSBI) Family Medicine and other primary care practices. Referrals will be through primary care providers or by patient self-referral. The goal of this project is to develop a low-cost, effective integrative intervention for chronic pain which can be replicated in underserved settings across the U.S. The physician in charge of this study is Benjamin Kligler, M.D., M.P.H.
Eligible participants will be scheduled for a face-to-face interview, at which time consent will be obtained and baseline measures will be collected. Baseline measures include collecting demographic data and information on depression, pain/pain free days and medication use.
To follow, a 4-week run-in period where usual care is delivered will be held to establish baseline pain levels. During this time, participants will be contacted at 2-week intervals to complete a brief pain assessment. If a waiting list becomes necessary, delay may become longer.
Participants will then be invited to participate in an 8-week, group-based acupuncture treatment intervention delivered by a licensed acupuncturist. The group will meet weekly for 8 consecutive weeks, each session lasting about 75 minutes held at the Center for Health and Healing located at 245 Fifth Ave in Manhattan. Sessions will be held during evening and weekend hours to facilitate scheduling.
We will collect information on pain, pain symptoms, mood, function and analgesic use at 1, 8, 12 and 24 week(s) following the beginning of the intervention. We will collect this information in-person or by telephone as preferred by the participant. Participants will not receive an incentive to attend group sessions but will receive incentives at enrollment and for completing research interviews at 12 and 24 weeks following treatment intervention ($20 at each of these three time points).
While subject records are confidential, there may be loss of confidentiality due to the group acupuncture setting. Intervention risks are low: Acupuncture needles are pre-sterilized and inserted once only and then properly discarded. Acupuncture therapy is safe with a 'relative' risk that is low. The risks associated with providing protected health information (PHI) will be minimized by assigning a unique participant identification code (ID number) that will be used to identify all data reported for each participant. The study staff will store all PHI in a secure and protected site at the Center for Health and Healing. The study results will be stored in a locked cabinet and any study information stored in a computer will be password protected. Only the study staff will have access to the study results.
Subjects will be reminded of the elements of participation.
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 AcupunctureParticipants will then be invited to participate in an 8-week, group-based acupuncture treatment intervention delivered by a licensed acupuncturist. The group will meet weekly for 8 consecutive weeks, each session lasting about 75 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years of age or older, who understand English, are experiencing chronic musculoskeletal pain for three months or more and have not received acupuncture therapy in the past 3 months
Key exclusion criteria (1 listed)
- Exclusion criteria will also include patients who have 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 |
|---|---|---|
| Group Acupuncture | Other | Group Acupuncture |
Primary outcome
Change in pain symptoms
Time frame: 24 weeks
We will collect information on pain, pain symptoms, and analgesic use at 1, 8, 12 and 24 week(s) following the beginning of the intervention. We will collect this information in-person or by telephone as preferred by the participant.
Change in mood
Time frame: up to 24 weeks
We will collect information on mood at 1, 8, 12 and 24 week(s) following the beginning of the intervention. These measures will be collected by the use of validated tools which include scales and questionnaire such as BPI, CES-D and PGIC. We will track and see if our study interventions impact participants' mood
Change in analgesic use
Time frame: up to 24 weeks
We will collect information on pain, pain symptoms, and analgesic use at 1, 8, 12 and 24 week(s) following the beginning of the intervention. We will collect this information in-person or by telephone as preferred by the participant.
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 1 Dec 2016.
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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.
Benjamin Kligler, MD principal investigator
Beth Israel Medical Center
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 in people with Pain, run by Beth Israel Medical Center 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 1 inclusion and 1 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 1 Dec 2016. 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?
Change in pain symptoms (time frame: 24 weeks). 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?
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 1 Dec 2016.