Group Acupuncture for Pain

Pain Clinical Trial

— GAP  

Official title:

Group Acupuncture for Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328586
• Other study ID #: 070-14
• Status: Completed
• Phase: N/A
• First received: July 3, 2014
• Last updated: November 30, 2016
• Start date: July 2014
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Group Acupuncture

Locations

Country	Name	City	State
United States	The Center for Health and Healing	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 weeks	No
Primary	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	up to 24 weeks	No
Primary	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.	up to 24 weeks	No