Clinical trial NCT02328586: Group Acupuncture for Pain
Official title: Group Acupuncture for Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in pain symptoms
timeFrame: 24 weeks
measure: Change in mood
timeFrame: up to 24 weeks
measure: Change in analgesic use
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The Center for Health and Healing
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Benjamin Kligler, MD
role: PRINCIPAL_INVESTIGATOR
References: