N/A
Completed N=248
Evaluating the Effect of Acupuncture on Pain Relief Using Quantitative Sensory Testing (QST)
Source: ClinicalTrials.gov NCT01094782 ↗Enrolled (actual)
248
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants — 49.9; 50.5; 49.9; 49.5 Degrees Celcius
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants |
49.9; 50.5; 49.9; 49.5; 49.7; 50.1 | — |
| PRIMARY Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants |
49.8; 50.3; 50.2; 49.6; 50.3; 50.0 | — |
| PRIMARY Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants |
49.9; 50.3; 50.1; 50.1; 49.8; 49.2 | — |
| PRIMARY Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants |
1.2; 0.5; 2.1; 2.5; 2.8; 1.1 | — |
| PRIMARY Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants |
1.7; 0.3; 1.9; 2.2; 2.8; 2.4 | — |
| PRIMARY Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants |
1.8; 0.1; 2; 3.7; 3.3; 1.9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01094782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.