Evaluating the Effect of Acupuncture on Pain Relief Using QST
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 254
- Locations
- 1
- Primary Endpoint
- Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to explore a new approach in assessing the effectiveness of acupuncture therapy in the treatment chronic pain conditions.
Investigators
Jianren Mao, MD, PhD
Director
Massachusetts General Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants
Time Frame: End of Week 2
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.
Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants
Time Frame: End of Week 4
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.
Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants
Time Frame: Start of Week 1
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.
Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants
Time Frame: Start of Week 1
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.
Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants
Time Frame: End of Week 2
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.
Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants
Time Frame: End of Week 4
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.