Evaluating the Effect of Acupuncture on Pain Relief Using Quantitative Sensory Testing (QST)

Study Overview
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Brief Summary
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The purpose of this study is to explore a new approach in assessing the effectiveness of acupuncture therapy in the treatment chronic pain conditions.

Official Title
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Evaluating the Effect of Acupuncture on Pain Relief Using QST

Conditions
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Pain

Intervention / Treatment
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* Other: Acupuncture
* Other: Sham Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject will be between ages 18 to 65 years. Both male and female subjects will be recruited. Subject should have had cervical or lumbar radicular pain for at least two months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation. Subject has a pain score of 4 or above (Visual Analog Scale (VAS): 0 - 10 from no pain to worst pain). Cervical or lumbar radicular pain will include, but is not limited to, such clinical conditions as disk herniation, spinal stenosis, and post-laminectomy syndrome. For controls, healthy subjects without radicular pain for at least three months will be recruited. *We are no longer accepting healthy volunteers.* Exclusion Criteria: Subject has detectable sensory deficits at the site of QST. Sensory deficits refer to such conditions resulting from neurological diseases or medical conditions causing peripheral polyneuropathy and sensory changes, which include but are not limited to diabetic neuropathy, alcoholic neuropathy, AIDS neuropathy, severe thyroid disease, and severe liver or kidney disorders. Subject has scar tissue, infection, or acute injury at the site of QST. Subject is on anticoagulation therapy. Subject is pregnant. Subject is tested positive on illicit drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy - True Acupuncture<br>Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.This group received true acupuncture treatment (the needles punctured the skin). | Other: Acupuncture<br>* Subjects receive 6 acupuncture treatments for neck or back pain.<br>|
| Sham Comparator: Healthy - Sham Acupuncture<br>Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin). | Other: Sham Acupuncture<br>* Subjects receive 6 sham acupuncture treatments for neck or back pain.<br>|
| No Intervention: Healthy - No Treatment<br>Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment. | |
| Active Comparator: Pain - True Acupuncture<br>Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received true acupuncture treatment (the needles punctured the skin). | Other: Acupuncture<br>* Subjects receive 6 acupuncture treatments for neck or back pain.<br>|
| Sham Comparator: Pain - Sham Acupuncture<br>Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin). | Other: Sham Acupuncture<br>* Subjects receive 6 sham acupuncture treatments for neck or back pain.<br>|
| No Intervention: Pain - No Treatment<br>Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants | Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule. | Start of Week 1 | 
| Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants | Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject. | End of Week 2 | 
| Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants | Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject. | End of Week 4 | 
| Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants | Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule. | Start of Week 1 | 
| Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants | Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject. | End of Week 2 | 
| Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants | Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject. | End of Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Pain management