NCT02328586

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

July 3, 2014

Last Update Submit

November 30, 2016

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

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.

Other: Group Acupuncture

Interventions

Group AcupunctureOTHER
Group Acupuncture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Health and Healing

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benjamin Kligler, MD

    Beth Israel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2014

First Posted

December 31, 2014

Study Start

July 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 1, 2016

Record last verified: 2016-11

Locations

US(1)