PainAcuspineNCT01304979
'Acupuncture Therapy' for Pain and Function Recovery in Spine Surgery Patients
A study testing Acupuncture therapies in people with Pain and Low Back 'Spine Fusion' Surgery, run by Beth Israel Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Low Back 'Spine Fusion' Surgery
- What is being tested?
- Acupuncture therapies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21 and older
- English speaking
- Admitted for lumbar spine surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Medical Center Orthopedic Surgery, Spine Center
New York, New York, 10003
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Pain, Low Back 'Spine Fusion' Surgery
- Being tested
- Acupuncture therapies, Control
- Keywords
- acupuncture, auricular acu-therapy, gua sha therapy, low back 'spine fusion', post surgical pain, post surgical recovery, Pain and recovery from 'spine fusion' surgery
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture therapiesProcedure or surgery
Also called Acupuncture auricular therapy, Acupuncture therapy, Gua sha therapy
Acupuncture therapies combined in treatment: application of ear seeds; acupuncture; and acupuncture with gua sha treatment designed to relieve pain and facilitate recovery.
ControlProcedure or surgery
Also called Indirect auricular therapy, Indirect acupuncture therapy
Indirect therapies that mimic direct therapy intervention
| Study group | Role | What they receive |
|---|---|---|
| Usual care alone | No intervention | Subjects receive usual care alone before and after spine fusion surgery |
| Active Intervention | Experimental | Acupuncture therapies, ear seeds, acupuncture treatment and gua sha, designed to reduce pain and facilitate recovery for low back spine fusion patients. Receives: Procedure: Acupuncture therapies |
| Control Arm | Sham comparator | Indirect therapies with same encounter time and timing as direct care group. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3rd day, 7-10 days and at 4-6 weeks
Secondary outcomes (1)
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.
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startSep 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arya Nielsen, PhD, Principal investigator, Beth Israel Medical Center Integrative Medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304979
- Sponsor's protocol ID
- 035-10
- Acronym
- Acuspine
- Status last verified
- Dec 2014
- First submitted
- 22 Oct 2010
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Acupuncture Therapy' for Pain and Function Recovery in Spine Surgery Patients
- ClinicalTrials.gov ID
- NCT01304979
- Acronym / sponsor ID
- Acuspine / 035-10
- Conditions
- Pain, Low Back 'Spine Fusion' Surgery
- Keywords
- 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 type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care alone | No intervention | –Subjects receive usual care alone before and after spine fusion surgery |
| Active Intervention | Experimental | Procedure: Acupuncture therapiesAcupuncture therapies, ear seeds, acupuncture treatment and gua sha, designed to reduce pain and facilitate recovery for low back spine fusion patients. |
| Control Arm | Sham comparator | Procedure: ControlIndirect therapies with same encounter time and timing as direct care group. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 21 and older
- English speaking
- Admitted for lumbar spine surgery
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture therapiesAlso: Acupuncture auricular therapy, Acupuncture therapy, Gua sha therapyAcupuncture therapies combined in treatment: application of ear seeds; acupuncture; and acupuncture with gua sha treatment designed to relieve pain and facilitate recovery. | Procedure or surgery | Active Intervention |
| ControlAlso: Indirect auricular therapy, Indirect acupuncture therapyIndirect therapies that mimic direct therapy intervention | Procedure or surgery | Control Arm |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arya Nielsen, PhD principal investigator
Beth Israel Medical Center Integrative Medicine Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture therapies in people with Pain and Low Back 'Spine Fusion' Surgery, run by Beth Israel Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores on Visual Analog Scale and Brief Pain Inventory (time frame: 3rd day, 7-10 days and at 4-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.