N/A
N=56
Effect of Acupuncture and Pain Medication on Radicular Pain Using QST
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01678586 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain) — 26.41; 26.54; 27.92; 24.25 degree celsius
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupuncture (Other); Sham Acupuncture (Other); Gabapentin (Drug); Sham Gabapentin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain) |
26.41; 26.54; 27.92; 24.25; 38.43; 39.57 | — |
| PRIMARY Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 HPT, CPT and Tol (HPT: Heat Pain Threshold; CPT: Cold Pain Threshold; Tol: Tolerance to 47°C Heat Stimulation) |
48.95; 49.93; 49.59; 48.95; 5.16; 4.7 | — |
Summary
In this aim, we propose to conduct a double blinded, placebo-controlled, and randomized clinical trial to compare the clinical effectiveness of radicular pain relief by either acupuncture therapy or a course of pain medication (e.g., Gabapentin) using Quantitative Sensory Testing (QST).
Eligibility Criteria
Inclusion Criteria
- Subject will be between ages 18 to 75 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.
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 pregnant.
- Subject tests positive for illicit drugs.
- Subject has a pacemaker.
- Subject is currently taking gabapentin.
Data sourced from ClinicalTrials.gov (NCT01678586). 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.