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

NCT01304979 | Completed DMC

• 1 other identifier: 035-10
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

acupuncture; auricular acu-therapy; gua sha therapy; low back 'spine fusion'; post surgical pain; post surgical recovery; Pain and recovery from 'spine fusion' surgery

Outcome Measures

Primary Outcomes (1)

• Pain scores on Visual Analog Scale and Brief Pain Inventory

  Does this combination of acupuncture therapies: ear seeds, acupuncture and acupuncture with gua sha given in hospital before and after low back 'spine fusion' surgery reduce pain over a 4-6 week period of recovery compared to control and usual care alone.

  3rd day, 7-10 days and at 4-6 weeks

Secondary Outcomes (1)

• Measure of 'return to function' on Short form Survey Instrument (SF-36) and Oswestry Disability Index (ODI) from baseline to '4-6 week' follow-up

  4-6 weeks

Study Arms (3)

Usual care alone

NO INTERVENTION

Subjects receive usual care alone before and after spine fusion surgery

Active Intervention

EXPERIMENTAL

Acupuncture therapies, ear seeds, acupuncture treatment and gua sha, designed to reduce pain and facilitate recovery for low back spine fusion patients.

Procedure: Acupuncture therapies

Control Arm

SHAM COMPARATOR

Indirect therapies with same encounter time and timing as direct care group.

Procedure: Control

Interventions

Acupuncture therapies PROCEDURE

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

Also known as: Acupuncture auricular therapy, Acupuncture therapy, Gua sha therapy

Active Intervention

Control PROCEDURE

Indirect therapies that mimic direct therapy intervention

Also known as: Indirect auricular therapy, Indirect acupuncture therapy

Control Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 and older
• English speaking
• Admitted for lumbar spine surgery

You may not qualify if:

• No serious psychiatric illness
• Subject has not had acupuncture for four weeks prior to surgery
• Subject agrees to not have elective acupuncture for 6 weeks after surgery

Sponsors & Collaborators

• Beth Israel Medical Center: lead

Study Sites (1)

Beth Israel Medical Center Orthopedic Surgery, Spine Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Arya Nielsen, PhD

  Beth Israel Medical Center Integrative Medicine Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: February 28, 2011
• Study Start: September 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

US (1)