Trial · NCT01678586
Effect of Acupuncture and Pain Medication on Radicular Pain Using QST
NCT01678586, Not applicable, Completed, Massachusetts General Hospital; results first posted 2024-04-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Acupuncture and Pain Medication on Radicular Pain Using QST. Trials, record NCT01678586. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01678586
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Acupuncture and Pain Medication on Radicular Pain Using QST
- NCT number
- NCT01678586
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 56 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Pain
- Interventions
- Acupuncture, Sham Acupuncture, Gabapentin, Sham Gabapentin
- First posted
- 2012-09-05
- Last updated
- 2024-04-23
- Results first posted
- 2024-04-23
- Limitations and caveats
A major limitation is the limited number of study participants in each group. In addition, the use of a sham needle in this pilot study may not have fully differentiated sham versus true electroacupuncture. While the use of diphenhydramine as a placebo control for gabapentin may have mimicked certain side effects of gabapentin, it may have had other confounding effects on the data interpretation.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups. | Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen. Measurements are taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups or within treatment week 3 for medication groups), up to a maximum of 3 weeks for each participant. |
| 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) | 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups. | Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen. Measurements are taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups or within treatment week 3 for medication groups), up to a maximum of 3 weeks for each participant. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups. | Enrolled participants who didn't withdraw, were not withdrawn by the investigator. | degree celsius | MEAN |
| 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) | 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups. | Enrolled participants who didn't withdraw, were not withdrawn by the investigator. | Seconds | MEAN |
Source ClinicalTrials.gov
Results by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | True Acupuncture | Visit 1 Cold Sensation | 26.41 | Standard Deviation 5.01 | degree celsius |
| 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) | Sham Acupuncture | Visit 1 Cold Sensation | 26.54 | Standard Deviation 2.44 | degree celsius |
| 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) | Gabapentin | Visit 1 Cold Sensation | 27.92 | Standard Deviation 2.22 | degree celsius |
| 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) | Sham Gabapentin | Visit 1 Cold Sensation | 24.25 | Standard Deviation 4.27 | degree celsius |
| 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) | True Acupuncture | Visit 1 Warm Sensation | 38.43 | Standard Deviation 4.03 | degree celsius |
| 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) | Sham Acupuncture | Visit 1 Warm Sensation | 39.57 | Standard Deviation 4.63 | degree celsius |
| 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) | Gabapentin | Visit 1 Warm Sensation | 38.49 | Standard Deviation 4.89 | degree celsius |
| 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) | Sham Gabapentin | Visit 1 Warm Sensation | 39.90 | Standard Deviation 4.61 | degree celsius |
| 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) | True Acupuncture | Visit 1 Heat Pain | 45.77 | Standard Deviation 5.08 | degree celsius |
| 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) | Sham Acupuncture | Visit 1 Heat Pain | 47.05 | Standard Deviation 3.55 | degree celsius |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | True Acupuncture | 15 | |
| Overall Study | STARTED | Sham Acupuncture | 16 | |
| Overall Study | STARTED | Gabapentin | 11 | |
| Overall Study | STARTED | Sham Gabapentin | 14 | |
| Overall Study | COMPLETED | True Acupuncture | 14 | |
| Overall Study | COMPLETED | Sham Acupuncture | 15 | |
| Overall Study | COMPLETED | Gabapentin | 9 | |
| Overall Study | COMPLETED | Sham Gabapentin | 12 | |
| Overall Study | NOT COMPLETED | True Acupuncture | 1 | |
| Overall Study | NOT COMPLETED | Sham Acupuncture | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Skin Redness | Skin and subcutaneous tissue disorders | True Acupuncture | 0 | 15 | 0 |
| other | Skin Redness | Skin and subcutaneous tissue disorders | Sham Acupuncture | 1 | 16 | 1 |
| other | Skin Redness | Skin and subcutaneous tissue disorders | Gabapentin | 0 | 11 | 0 |
| other | Skin Redness | Skin and subcutaneous tissue disorders | Sham Gabapentin | 0 | 14 | 0 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | True Acupuncture | 0 | 15 |
| Total, all-cause mortality | Sham Acupuncture | 0 | 16 |
| Total, all-cause mortality | Gabapentin | 0 | 11 |
| Total, all-cause mortality | Sham Gabapentin | 0 | 14 |
| Total, other adverse events | True Acupuncture | 0 | 15 |
| Total, other adverse events | Sham Acupuncture | 1 | 16 |
| Total, other adverse events | Gabapentin | 0 | 11 |
| Total, other adverse events | Sham Gabapentin | 0 | 14 |
| Total, serious adverse events | True Acupuncture | 0 | 15 |
| Total, serious adverse events | Sham Acupuncture | 0 | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34325532 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AT005819 | A Method for Evaluating Acupuncture Therapy in Pain Management | CHEN, LUCY L. | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH | 2009 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01678586
GET https://conductscience.org/api/trials/v1/NCT01678586/results?page=2