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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shen Men acupuncture | Experimental | Single acupuncture needles will be placed bilaterally onto the patient's Shen Men acupuncture point in the ear for a duration of 20 minutes. |
|
| Sham acupuncture | Sham Comparator | Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes. |
|
| Simulated acupuncture | Placebo Comparator | Acupuncture will be simulated with a paper clip. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shen Men acupuncture | Device | 20-minute acupuncture session |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Simulated Acupuncture | Acupuncture will be simulated with a paper clip. Epidural injection: Epidural injection for the relief of back pain |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 30 min post-acupuncture intervention |
|
Adverse event data were collected during the duration of the acupuncture intervention (20 minutes).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Kirschner | Hospital for Special Surgery | 6467146327 | kirschnerj@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2018 | Aug 28, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007268 | Injections, Epidural |
| ID | Term |
|---|---|
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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| Epidural injection |
| Procedure |
Epidural injection for the relief of back pain |
|
Any use of medication use following the acupuncture intervention and before the epidural injection will be documented. |
| Up to 30 min post-acupuncture intervention. |
| 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 |
| BG002 | Simulated Acupuncture | Acupuncture will be simulated with a paper clip. Epidural injection: Epidural injection for the relief of back pain |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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 |
| OG001 | 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 |
| OG002 | Simulated Acupuncture | Acupuncture will be simulated with a paper clip. Epidural injection: Epidural injection for the relief of back pain |
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | Up to 30 min post-acupuncture intervention |
|
|
|
| Secondary | Anxiety Medication Use | Any use of medication use following the acupuncture intervention and before the epidural injection will be documented. | Posted | Count of Participants | Participants | Up to 30 min post-acupuncture intervention. |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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 | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | Simulated Acupuncture | Acupuncture will be simulated with a paper clip. Epidural injection: Epidural injection for the relief of back pain | 0 | 1 | 0 | 1 | 0 | 1 |
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| D013812 |
| Therapeutics |