Clinical trial NCT01094782: Evaluating the Effect of Acupuncture on Pain Relief Using Quantitative Sensory Testing (QST)
Official title: Evaluating the Effect of Acupuncture on Pain Relief Using QST
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain
Pain management
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-03-29
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

1. Subject will be between ages 18 to 65 years. Both male and female subjects will be recruited.
2. 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.
3. Subject has a pain score of 4 or above (Visual Analog Scale (VAS): 0 - 10 from no pain to worst pain).
4. Cervical or lumbar radicular pain will include, but is not limited to, such clinical conditions as disk herniation, spinal stenosis, and post-laminectomy syndrome.
5. For controls, healthy subjects without radicular pain for at least three months will be recruited. \*We are no longer accepting healthy volunteers.\*

Exclusion Criteria:

1. 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.
2. Subject has scar tissue, infection, or acute injury at the site of QST.
3. Subject is on anticoagulation therapy.
4. Subject is pregnant.
5. Subject is tested positive on illicit drugs.

Primary outcomes:
measure: Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants
timeFrame: Start of Week 1
measure: Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants
timeFrame: End of Week 2
measure: Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants
timeFrame: End of Week 4
measure: Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants
timeFrame: Start of Week 1
measure: Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants
timeFrame: End of Week 2
measure: Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants
timeFrame: End of Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Center for Translational Pain Research
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lucy Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: