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Acupuncture for Pre-Procedure Anxiety

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ClinicalTrials.gov Identifier: NCT03480919
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:
It is common for patients undergoing spinal injections to report anxiety prior to the injection. Although sedation, general anesthesia, and medications can be used to reduce anxiety, the use of sedative agents during the procedure can increase the risk of spinal cord injury. The purpose of this study is to see if receiving acupuncture before a spinal injection can effectively reduce patients' anxiety. Only patients who are scheduled to receive a spinal injection at this institution will be eligible for the study.

Condition or disease Intervention/treatment Phase
Anxiety Device: Shen Men acupuncture Procedure: Epidural injection Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shen Men Acupuncture for Anxiety Preceding Lumbar Epidural Injections in Acupuncture-naive Patients: a Randomized Controlled Trial
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Shen Men acupuncture
Single acupuncture needles will be placed bilaterally onto the patient's Shen Men acupuncture point in the ear for a duration of 20 minutes.
Device: Shen Men acupuncture
20-minute acupuncture session
Procedure: Epidural injection
Epidural injection for the relief of back pain
Sham Comparator: Sham acupuncture
Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes.
Procedure: Epidural injection
Epidural injection for the relief of back pain
Placebo Comparator: Simulated acupuncture
Acupuncture will be simulated with a paper clip.
Procedure: Epidural injection
Epidural injection for the relief of back pain



Primary Outcome Measures :
  1. Anxiety [ Time Frame: Up to 30 min post-acupuncture intervention ]
    Change in anxiety from baseline (pre-acupuncture intervention) will be measured using the State subscale of the State Trait Anxiety Inventory.


Secondary Outcome Measures :
  1. Belief of acupuncture [ Time Frame: Up to 30 min post-acupuncture intervention ]
    Patients will be asked "On a scale of 0-10, how much do you believe acupuncture to be a valid treatment for anxiety?" (0=do not believe at all; 10=fully believe)

  2. Anxiety medication use [ Time Frame: Up to 30 min post-acupuncture intervention. ]
    Any use of medication use following the acupuncture intervention and before the epidural injection will be documented.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18+
  • Spine pathology that meets criteria for lumbar epidural injection

Exclusion Criteria:

  • Unable to provide consent
  • Contraindications to acupuncture (e.g., rash, skin infection, sensory loss in ear)
  • Previous experience of acupuncture
  • Age <18
  • Pregnant women
  • Non-English or Non-Spanish speaking

Information from the National Library of Medicine

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): NCT03480919


Contacts
Contact: Jennifer Cheng 6467146870 chengj@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Tziporia Kuba       kubat@hss.edu   
Sponsors and Collaborators
Hospital for Special Surgery, New York

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03480919     History of Changes
Other Study ID Numbers: 2017-1525
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders