'Acupuncture Therapy' for Pain and Function Recovery in Spine Surgery Patients (Acuspine)
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|ClinicalTrials.gov Identifier: NCT01304979|
Recruitment Status : Completed
First Posted : February 28, 2011
Last Update Posted : December 30, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain Low Back 'Spine Fusion' Surgery||Procedure: Acupuncture therapies Procedure: Control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||'Acupuncture Therapy' for Pain and Function Recovery in Spine Surgery Patients|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
No Intervention: Usual care alone
Subjects receive usual care alone before and after spine fusion surgery
Experimental: Active Intervention
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
Acupuncture therapies combined in treatment: application of ear seeds; acupuncture; and acupuncture with gua sha treatment designed to relieve pain and facilitate recovery.
Sham Comparator: Control Arm
Indirect therapies with same encounter time and timing as direct care group.
Indirect therapies that mimic direct therapy intervention
- Pain scores on Visual Analog Scale and Brief Pain Inventory [ Time Frame: 3rd day, 7-10 days and at 4-6 weeks ]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.
- 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 [ Time Frame: 4-6 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304979
|United States, New York|
|Beth Israel Medical Center Orthopedic Surgery, Spine Center|
|New York, New York, United States, 10003|
|Principal Investigator:||Arya Nielsen, PhD||Beth Israel Medical Center Integrative Medicine Department|