Acupuncture for Pre-Procedure Anxiety

• Shen Men acupuncture (Device): 20-minute acupuncture session
• Epidural injection (Procedure): Epidural injection for the relief of back pain

Primary outcomes

• Anxiety [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 (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.

Secondary outcomes

• Belief of Acupuncture [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)
• Anxiety Medication Use [Up to 30 min post-acupuncture intervention.]: Any use of medication use following the acupuncture intervention and before the epidural injection will be documented.

Sex: All, ages: 18 Years to 100 Years

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

Participant flow

Outcome results

• Anxiety (Primary), Mean, score on a scale: Shen Men Acupuncture 0 +/- 0; Sham Acupuncture 0.2 +/- 4.5; Simulated Acupuncture -6 +/- 0
• Belief of Acupuncture (Secondary), Mean, units on a scale: Shen Men Acupuncture 8 +/- 0; Sham Acupuncture 8 +/- 4; Simulated Acupuncture 7 +/- 0
• Anxiety Medication Use (Secondary), Count of participants, Participants: Shen Men Acupuncture 0; Sham Acupuncture 0; Simulated Acupuncture 0

Adverse events

Time frame: Adverse event data were collected during the duration of the acupuncture intervention (20 minutes).

• Study Protocol and Statistical Analysis Plan (PDF, 2018-03-07)