Anxiety
Conditions
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.
Interventions
DEVICEShen Men acupuncture
20-minute acupuncture session
PROCEDUREEpidural injection
Epidural injection for the relief of back pain
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Shen Men acupuncture: 20-minute acupuncture session
Epidural injection: Epidural injection for the relief of back pain | 1 |
| Sham Acupuncture Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes.
Epidural injection: Epidural injection for the relief of back pain | 2 |
| Simulated Acupuncture Acupuncture will be simulated with a paper clip.
Epidural injection: Epidural injection for the relief of back pain | 1 |
| Total | 4 |
Baseline characteristics
| Characteristic | Shen Men Acupuncture | Sham Acupuncture | Simulated Acupuncture | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Continuous | 36 years STANDARD_DEVIATION 0 | 65 years STANDARD_DEVIATION 0 | 87 years STANDARD_DEVIATION 0 | 63 years STANDARD_DEVIATION 21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 2 participants | 1 participants | 4 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 | 0 / 1 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shen Men Acupuncture | Anxiety | 0 score on a scale | Standard Deviation 0 |
| Sham Acupuncture | Anxiety | 0.2 score on a scale | Standard Deviation 4.5 |
| Simulated Acupuncture | Anxiety | -6 score on a scale | Standard Deviation 0 |
Secondary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Shen Men Acupuncture | Anxiety Medication Use | 0 Participants |
| Sham Acupuncture | Anxiety Medication Use | 0 Participants |
| Simulated Acupuncture | Anxiety Medication Use | 0 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Shen Men Acupuncture | Belief of Acupuncture | 8 units on a scale | Standard Deviation 0 |
| Sham Acupuncture | Belief of Acupuncture | 8 units on a scale | Standard Deviation 4 |
| Simulated Acupuncture | Belief of Acupuncture | 7 units on a scale | Standard Deviation 0 |