Group Acupuncture for Pain

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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).