Acupuncture for Pre-Procedure Anxiety

Hospital for Special Surgery (HSS)

Status: Terminated

Conditions: Anxiety

Treatments: Procedure: Epidural injection; Device: Shen Men acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03480919

2017-1525

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4 participants in 3 patient groups, including a placebo group

Shen Men acupuncture

Experimental group

Description:

Single acupuncture needles will be placed bilaterally onto the patient's Shen Men acupuncture point in the ear for a duration of 20 minutes.

Treatment:

Device: Shen Men acupuncture

Procedure: Epidural injection

Sham acupuncture

Sham Comparator group

Description:

Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes.

Treatment:

Procedure: Epidural injection

Simulated acupuncture

Placebo Comparator group

Description:

Acupuncture will be simulated with a paper clip.

Treatment:

Procedure: Epidural injection