An interventional study of Shen Men acupuncture and Epidural injection in Anxiety, sponsored by Hospital for Special Surgery, New York. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-11-12.
Sponsored by Hospital for Special Surgery, New York · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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 · Procedure: Epidural injection
Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes.
Procedure: Epidural injection
Acupuncture will be simulated with a paper clip.
Procedure: Epidural injection
20-minute acupuncture session
Epidural injection for the relief of back pain
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.
Time frame: Up to 30 min post-acupuncture intervention
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)
Time frame: 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.
Time frame: Up to 30 min post-acupuncture intervention.
| Milestone | Shen Men Acupuncture | Sham Acupuncture | Simulated Acupuncture |
|---|---|---|---|
| Started | 1 | 2 | 1 |
| Completed | 1 | 2 | 1 |
| Not completed | 0 | 0 | 0 |
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.
| score on a scale | Shen Men Acupuncture | Sham Acupuncture | Simulated Acupuncture |
|---|---|---|---|
| Anxiety | 0 ± 0 | 0.2 ± 4.5 | -6 ± 0 |
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)
| units on a scale | Shen Men Acupuncture | Sham Acupuncture | Simulated Acupuncture |
|---|---|---|---|
| Belief of Acupuncture | 8 ± 0 | 8 ± 4 | 7 ± 0 |
Any use of medication use following the acupuncture intervention and before the epidural injection will be documented.
| Participants | Shen Men Acupuncture | Sham Acupuncture | Simulated Acupuncture |
|---|---|---|---|
| Anxiety Medication Use | 0 | 0 | 0 |
Collected over Adverse event data were collected during the duration of the acupuncture intervention (20 minutes).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Shen Men Acupuncture | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Sham Acupuncture | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Simulated Acupuncture | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Shen Men Acupuncture | Sham Acupuncture | Simulated Acupuncture | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 0 | 0 | 1 |
| >=65 years | 0 | 2 | 1 | 3 |
| Age, Continuous(years) | Shen Men Acupuncture | Sham Acupuncture | Simulated Acupuncture | Total |
|---|---|---|---|---|
| Mean | 36 ± 0 | 65 ± 0 | 87 ± 0 | 63 ± 21 |
| Sex: Female, Male(Participants) | Shen Men Acupuncture | Sham Acupuncture | Simulated Acupuncture | Total |
|---|---|---|---|---|
| Female | 0 | 2 | 1 | 3 |
| Male | 1 | 0 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Shen Men Acupuncture | Sham Acupuncture | Simulated Acupuncture | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 1 |
| Not Hispanic or Latino | 1 | 1 | 1 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Shen Men Acupuncture | Sham Acupuncture | Simulated Acupuncture | Total |
|---|---|---|---|---|
| United States | 1 | 2 | 1 | 4 |
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Hospital for Special Surgery, New York