Acupuncture for Pre-Procedure Anxiety

Study Overview
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Brief Summary
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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.

Official Title
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Shen Men Acupuncture for Anxiety Preceding Lumbar Epidural Injections in Acupuncture-naive Patients: a Randomized Controlled Trial

Conditions
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Anxiety

Intervention / Treatment
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* Device: Shen Men acupuncture
* Procedure: Epidural injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shen Men acupuncture<br>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<br>* 20-minute acupuncture session<br>Procedure: Epidural injection<br>* Epidural injection for the relief of back pain<br>|
| Sham Comparator: Sham acupuncture<br>Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes. | Procedure: Epidural injection<br>* Epidural injection for the relief of back pain<br>|
| Placebo Comparator: Simulated acupuncture<br>Acupuncture will be simulated with a paper clip. | Procedure: Epidural injection<br>* Epidural injection for the relief of back pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Change in anxiety from baseline (pre-acupuncture intervention) will be measured using the State subscale of the State Trait Anxiety Inventory (STAI). The STAI is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI is one of the first tests to assess both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored. Scores range from 20 to 80, with higher scores correlating with greater anxiety. Low scores indicate a mild form of anxiety whereas median scores indicate a moderate form of anxiety and high scores indicate a severe form of anxiety. The 4-point scale for S-anxiety is as follows: 1.) not at all, 2.) somewhat, 3.) moderately so, 4.) very much so. The 4-point scale for T-anxiety is as follows: 1.) almost never, 2.) sometimes, 3.) often, 4.) almost always. | Up to 30 min post-acupuncture intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Belief of Acupuncture | 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) | Up to 30 min post-acupuncture intervention | 
| Anxiety Medication Use | Any use of medication use following the acupuncture intervention and before the epidural injection will be documented. | Up to 30 min post-acupuncture intervention. |