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

NCT ID: NCT01304979

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain Low Back 'Spine Fusion' Surgery

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Usual care alone

Subjects receive usual care alone before and after spine fusion surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Active Intervention

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

Group Type EXPERIMENTAL

Acupuncture therapies

Intervention Type PROCEDURE

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

Control Arm

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

Group Type SHAM_COMPARATOR

Control

Intervention Type PROCEDURE

Indirect therapies that mimic direct therapy intervention

Interventions

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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.

Intervention Type PROCEDURE

Control

Indirect therapies that mimic direct therapy intervention

Intervention Type PROCEDURE

Other Intervention Names

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Acupuncture auricular therapy Acupuncture therapy Gua sha therapy Indirect auricular therapy Indirect acupuncture therapy

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beth Israel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arya Nielsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Medical Center Integrative Medicine Department

Locations

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Beth Israel Medical Center Orthopedic Surgery, Spine Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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035-10

Identifier Type: -

Identifier Source: org_study_id