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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01304979
First received: October 22, 2010
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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 Intervention
Pain
Low Back 'Spine Fusion' Surgery
Procedure: Acupuncture therapies
Procedure: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 'Acupuncture Therapy' for Pain and Function Recovery in Spine Surgery Patients

Resource links provided by NLM:


Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • Pain scores on Visual Analog Scale and Brief Pain Inventory [ Time Frame: 3rd day, 7-10 days and at 4-6 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 114
Study Start Date: September 2010
Estimated Study Completion Date: November 2100
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Acupuncture auricular therapy
  • Acupuncture therapy
  • Gua sha therapy
Sham Comparator: Control Arm
Indirect therapies with same encounter time and timing as direct care group.
Procedure: Control
Indirect therapies that mimic direct therapy intervention
Other Names:
  • Indirect auricular therapy
  • Indirect acupuncture therapy

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304979

Locations
United States, New York
Beth Israel Medical Center Orthopedic Surgery, Spine Center
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
Principal Investigator: Arya Nielsen, PhD Beth Israel Medical Center Integrative Medicine Department
  More Information

No publications provided

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01304979     History of Changes
Other Study ID Numbers: 035-10
Study First Received: October 22, 2010
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Medical Center:
acupuncture
auricular acu-therapy
gua sha therapy
low back 'spine fusion'
post surgical pain
post surgical recovery
Pain and recovery from 'spine fusion' surgery

ClinicalTrials.gov processed this record on July 20, 2014