AnxietyNCT03480919
Acupuncture for Pre-Procedure Anxiety
A study testing Shen Men acupuncture and Epidural injection in people with Anxiety, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Shen Men acupuncture and Epidural injection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+
- Spine pathology that meets criteria for lumbar epidural injection
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Shen Men Acupuncture for Anxiety Preceding Lumbar Epidural Injections in Acupuncture-naive Patients: a Randomized Controlled Trial
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.
- Conditions
- Anxiety
- Being tested
- Shen Men acupuncture, Epidural injection
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shen Men acupunctureDevice
20-minute acupuncture session
Epidural injectionProcedure or surgery
Epidural injection for the relief of back pain
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Shen Men acupuncture; Procedure: Epidural injection |
| Sham acupuncture | Sham comparator | Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes. Receives: Procedure: Epidural injection |
| Simulated acupuncture | Placebo comparator | Acupuncture will be simulated with a paper clip. Receives: Procedure: Epidural injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 min post-acupuncture intervention
Secondary outcomes (2)
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)
Measured: 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.
Measured: Up to 30 min post-acupuncture intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start20 Mar 2018
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Why it stopped: Limited resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480919
- Sponsor's protocol ID
- 2017-1525
- Status last verified
- Nov 2019
- First submitted
- 20 Mar 2018
- Last updated
- 12 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shen Men Acupuncture for Anxiety Preceding Lumbar Epidural Injections in Acupuncture-naive Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03480919
- Acronym / sponsor ID
- 2017-1525
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited resources
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shen Men acupuncture | Experimental | Device: Shen Men acupuncture, Procedure: Epidural injectionSingle 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 | Procedure: Epidural injectionSingle acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes. |
| Simulated acupuncture | Placebo comparator | Procedure: Epidural injectionAcupuncture will be simulated with a paper clip. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18+
- Spine pathology that meets criteria for lumbar epidural injection
Key exclusion criteria (6 listed)
- Unable to provide consent
- Contraindications to acupuncture (e.g., rash, skin infection, sensory loss in ear)
- Previous experience of acupuncture
- Age <18
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shen Men acupuncture20-minute acupuncture session | Device | Shen Men acupuncture |
| Epidural injectionEpidural injection for the relief of back pain | Procedure or surgery | Sham acupuncture, Shen Men acupuncture, Simulated acupuncture |
Primary outcome
Anxiety
Time frame: 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.
2 secondary outcomes
Belief of Acupuncture
Time frame: Up to 30 min post-acupuncture intervention
Anxiety Medication Use
Time frame: Up to 30 min post-acupuncture intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shen Men acupuncture and Epidural injection in people with Anxiety, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Up to 30 min post-acupuncture intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.