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NCT01304979 · ClinicalTrials.gov registry record · NA
'Acupuncture Therapy' for Pain and Function Recovery in Spine Surgery Patients
A NA study, sponsored by Beth Israel Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 114
- Enrollment target
NCT01304979 is a NA study that has completed, run by Beth Israel Medical Center. The registered enrollment target is 114 participants.
The verdict
NCT01304979, a NA study, has completed, sponsored by Beth Israel Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 114 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Control
- PROCEDURE Acupuncture therapies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01304979
The ClinicalTrials.gov registry entry for NCT01304979 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Medical Center, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT01304979 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01304979 about?
NCT01304979 is a clinical study titled "'Acupuncture Therapy' for Pain and Function Recovery in Spine Surgery Patients". 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 ba...
What is the current status of trial NCT01304979?
This trial is currently completed. It is a NA study. The enrollment target is 114 participants. The study started on 2010-09. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01304979?
The interventions under investigation include: Control (PROCEDURE), Acupuncture therapies (PROCEDURE).
Who is sponsoring clinical trial NCT01304979?
This trial is sponsored by Beth Israel Medical Center, which has 44 total clinical trials registered on ClinicalTrials.gov.
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