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

Pain Clinical Trial

— Acuspine  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304979
• Other study ID #: 035-10
• Status: Completed
• Phase: N/A
• First received: October 22, 2010
• Last updated: December 29, 2014
• Start date: September 2010
• Est. completion date: May 2014

Study information

• Verified date: December 2014
• 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

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.

Description:

Active treatment will involve 3 acupuncture therapy sessions. The first encounter takes place in the holding area just prior to surgery. Subjects will have ear seeds (vacaria seeds prefixed to tape) placed on four ear points bilaterally: Shen men, Heart, Liver and Lumbar region point. These will remain on the ear for the duration of surgery and through discharge. If any one of the seeds falls off, it will be replaced at the next intervention session.

The second active session will include acupuncture needling at body points: some mandated, and some selected from listed options representing flexibility to individualize a treatment. Subject is likely in a supine position or sitting.

At third active intervention the subject will be positioned on body cushion in their hospital bed, prone. Light Gua sha will be applied at the paraspinal region above the surgical area, and across the gluteus medius area below same. If calves are tight or painful, light Gua sha may be applied. Mandated acupuncture points will be needled with selection of additional points based on pain and symptom presentation.

The control arm includes three encounters of 'indirect acupuncture therapy' timed identically to the active arm. In the first instead of ear seeds, blank pieces of tape will be applied to the subjects ears bilaterally in the holding area just prior to surgery.

The second encounter the subject will have their ear tape renewed if necessary; and 'vacaria seeded tape' will be fixed to the 'four-gates': Large Intestine 4 on the hand and Liver 3 on the foot and left in place for 20-25 minutes and then removed.

The final session will be a repeat of the second session.

Subjects will be told that the study is comparing kinds of acupuncture treatment: direct and indirect.

The third arm will be usual care alone. All subjects will receive usual care in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Age 21 and older

• English speaking

• Admitted for lumbar spine surgery

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Back 'Spine Fusion' Surgery
• Pain

Intervention

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.
• Control
Indirect therapies that mimic direct therapy intervention

Locations

Country	Name	City	State
United States	Beth Israel Medical Center Orthopedic Surgery, Spine Center	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	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	No
Secondary	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	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 facilitate return of function over a 4-6 week period of recovery compared to control and usual care alone.	4-6 weeks	No