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'Acupuncture Therapy' for Pain and Function Recovery in Spine Surgery Patients

NCT01304979 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2014-12-30

No results posted yet for this study

Summary

Acupuncture has been studied in the perioperative setting and shown to reduce pain, anxiety, nausea and vomiting. Studies have been conducted in orthopedic surgery patients, but not spine patients. The investigators study will look at a combination of acupuncture therapies for patients having low back spine fusions to assess pain levels and return to function.

114 subjects will be randomized into a direct acupuncture therapy group (38), an indirect acupuncture therapy group (38), or usual care alone (38). All subjects will receive usual care for spine fusion patients.

Direct acupuncture therapy subjects will have pre-op auricular seeds in four distinct ear points bilaterally, an acupuncture treatment on the day after surgery and an acupuncture treatment with gua sha on the 2nd day after surgery (typically day of discharge).

The indirect acupuncture therapy group will have treatment timed exactly as the direct intervention group but consist of 'indirect' treatment: tape placed at ear points at pre-op, ear seeds placed on several body points on the first and second day after surgery.

BPI, VAS, SPF36-2, and ODI measures will be taken at enrollment and at the 4-6 week follow-up appointment with subjects' spine surgeon. BPI and VAS will also be taken at day 3 and day 7-10 additionally.

Conditions

  • Pain
  • Low Back 'Spine Fusion' Surgery

Interventions

PROCEDURE

Acupuncture therapies

Acupuncture therapies combined in treatment: application of ear seeds; acupuncture; and acupuncture with gua sha treatment designed to relieve pain and facilitate recovery.

PROCEDURE

Control

Indirect therapies that mimic direct therapy intervention

Sponsors & Collaborators

  • Beth Israel Medical Center

    lead OTHER

Principal Investigators

  • Arya Nielsen, PhD · Beth Israel Medical Center Integrative Medicine Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01304979 on ClinicalTrials.gov