Pain
Conditions
Keywords
Pain, Pain management
Brief 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).
Interventions
DRUGGabapentin
Gabapentin is a commonly prescribed drug used to treat neuropathic pain.
OTHERSham Acupuncture
In sham acupuncture the needles do not penetrate the skin.
OTHERAcupuncture
In true acupuncture the needles penetrate the skin.
DRUGSham Gabapentin
Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject will be between ages 18 to 75 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.
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 pregnant. 4. Subject tests positive for illicit drugs. 5. Subject has a pacemaker. 6. Subject is currently taking gabapentin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| True Acupuncture Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments.
Acupuncture: In true acupuncture the needles penetrate the skin. | 15 |
| Sham Acupuncture Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments.
Sham Acupuncture: In sham acupuncture the needles do not penetrate the skin. | 16 |
| Gabapentin Pain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Gabapentin: Gabapentin is a commonly prescribed drug used to treat neuropathic pain. | 11 |
| Sham Gabapentin Pain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Sham Gabapentin: Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness) | 14 |
| Total | 56 |
Baseline characteristics
| Characteristic | True Acupuncture | Sham Acupuncture | Gabapentin | Sham Gabapentin | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 2 Participants | 4 Participants | 1 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 14 Participants | 7 Participants | 13 Participants | 45 Participants |
| Age, Continuous | 55.43 years STANDARD_DEVIATION 12.33 | 53.07 years STANDARD_DEVIATION 9.28 | 54.89 years STANDARD_DEVIATION 13.78 | 55.25 years STANDARD_DEVIATION 6.08 | 54.66 years STANDARD_DEVIATION 10.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 16 Participants | 11 Participants | 14 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 1 Participants | 0 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 12 Participants | 9 Participants | 8 Participants | 38 Participants |
| Region of Enrollment United States | 15 participants | 16 participants | 11 participants | 14 participants | 56 participants |
| Sex: Female, Male Female | 11 Participants | 5 Participants | 6 Participants | 7 Participants | 29 Participants |
| Sex: Female, Male Male | 4 Participants | 11 Participants | 5 Participants | 7 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 | 0 / 11 | 0 / 14 |
| other Total, other adverse events | 0 / 15 | 1 / 16 | 0 / 11 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 | 0 / 11 | 0 / 14 |
Outcome results
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)
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.
Time frame: 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.
Population: Enrolled participants who didn't withdraw, were not withdrawn by the investigator.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| True Acupuncture | 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) | Visit 7 Warm | 38.38 degree celsius | Standard Deviation 4.34 |
| True Acupuncture | 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) | Visit 7 Cold Pain | 10.47 degree celsius | Standard Deviation 8.87 |
| True Acupuncture | 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) | Visit 4 Cold Pain | 11.01 degree celsius | Standard Deviation 10.22 |
| True Acupuncture | 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) | Visit 1 Cold Sensation | 26.41 degree celsius | Standard Deviation 5.01 |
| True Acupuncture | 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) | Visit 7 Cold | 26.17 degree celsius | Standard Deviation 3.23 |
| True Acupuncture | 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) | Visit 1 Heat Pain | 45.77 degree celsius | Standard Deviation 5.08 |
| True Acupuncture | 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) | Visit 1 Cold pain | 11.11 degree celsius | Standard Deviation 11.77 |
| True Acupuncture | 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) | Visit 1 Warm Sensation | 38.43 degree celsius | Standard Deviation 4.03 |
| True Acupuncture | 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) | Visit 7 Heat Pain | 46.85 degree celsius | Standard Deviation 2.96 |
| True Acupuncture | 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) | Visit 4 Cold Sensation | 26.04 degree celsius | Standard Deviation 3.99 |
| True Acupuncture | 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) | Visit 4 Warm Sensation | 37.56 degree celsius | Standard Deviation 3.91 |
| True Acupuncture | 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) | Visit 4 Heat Pain | 46.15 degree celsius | Standard Deviation 3.46 |
| Sham Acupuncture | 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) | Visit 1 Warm Sensation | 39.57 degree celsius | Standard Deviation 4.63 |
| Sham Acupuncture | 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) | Visit 4 Heat Pain | 47.51 degree celsius | Standard Deviation 2.41 |
| Sham Acupuncture | 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) | Visit 1 Cold pain | 8.20 degree celsius | Standard Deviation 8.76 |
| Sham Acupuncture | 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) | Visit 7 Cold | 25.12 degree celsius | Standard Deviation 2.1 |
| Sham Acupuncture | 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) | Visit 7 Warm | 39.09 degree celsius | Standard Deviation 2.94 |
| Sham Acupuncture | 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) | Visit 4 Cold Pain | 9.55 degree celsius | Standard Deviation 9.66 |
| Sham Acupuncture | 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) | Visit 1 Cold Sensation | 26.54 degree celsius | Standard Deviation 2.44 |
| Sham Acupuncture | 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) | Visit 4 Warm Sensation | 39.15 degree celsius | Standard Deviation 3.65 |
| Sham Acupuncture | 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) | Visit 4 Cold Sensation | 25.11 degree celsius | Standard Deviation 6.73 |
| Sham Acupuncture | 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) | Visit 1 Heat Pain | 47.05 degree celsius | Standard Deviation 3.55 |
| Sham Acupuncture | 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) | Visit 7 Cold Pain | 8.42 degree celsius | Standard Deviation 9.98 |
| Sham Acupuncture | 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) | Visit 7 Heat Pain | 47.69 degree celsius | Standard Deviation 2.56 |
| Gabapentin | 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) | Visit 4 Cold Pain | 9.09 degree celsius | Standard Deviation 9.89 |
| Gabapentin | 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) | Visit 1 Cold Sensation | 27.92 degree celsius | Standard Deviation 2.22 |
| Gabapentin | 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) | Visit 1 Warm Sensation | 38.49 degree celsius | Standard Deviation 4.89 |
| Gabapentin | 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) | Visit 1 Heat Pain | 46.31 degree celsius | Standard Deviation 4.04 |
| Gabapentin | 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) | Visit 1 Cold pain | 9.65 degree celsius | Standard Deviation 10.87 |
| Gabapentin | 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) | Visit 4 Cold Sensation | 28.38 degree celsius | Standard Deviation 5.78 |
| Gabapentin | 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) | Visit 4 Warm Sensation | 37.11 degree celsius | Standard Deviation 3.45 |
| Gabapentin | 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) | Visit 4 Heat Pain | 45.92 degree celsius | Standard Deviation 4.07 |
| Gabapentin | 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) | Visit 7 Cold | 27.04 degree celsius | Standard Deviation 2.28 |
| Gabapentin | 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) | Visit 7 Warm | 37.59 degree celsius | Standard Deviation 3.64 |
| Gabapentin | 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) | Visit 7 Heat Pain | 46.73 degree celsius | Standard Deviation 1.91 |
| Gabapentin | 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) | Visit 7 Cold Pain | 12.63 degree celsius | Standard Deviation 10.05 |
| Sham Gabapentin | 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) | Visit 4 Warm Sensation | 37.50 degree celsius | Standard Deviation 3.4 |
| Sham Gabapentin | 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) | Visit 4 Cold Sensation | 26.35 degree celsius | Standard Deviation 3.9 |
| Sham Gabapentin | 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) | Visit 1 Cold Sensation | 24.25 degree celsius | Standard Deviation 4.27 |
| Sham Gabapentin | 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) | Visit 7 Warm | 38.33 degree celsius | Standard Deviation 3.94 |
| Sham Gabapentin | 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) | Visit 1 Cold pain | 9.87 degree celsius | Standard Deviation 10.53 |
| Sham Gabapentin | 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) | Visit 1 Heat Pain | 46.34 degree celsius | Standard Deviation 4.33 |
| Sham Gabapentin | 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) | Visit 7 Cold Pain | 13.82 degree celsius | Standard Deviation 8.8 |
| Sham Gabapentin | 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) | Visit 7 Heat Pain | 44.64 degree celsius | Standard Deviation 4.71 |
| Sham Gabapentin | 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) | Visit 4 Cold Pain | 14.13 degree celsius | Standard Deviation 10.79 |
| Sham Gabapentin | 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) | Visit 4 Heat Pain | 45.34 degree celsius | Standard Deviation 4.7 |
| Sham Gabapentin | 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) | Visit 1 Warm Sensation | 39.90 degree celsius | Standard Deviation 4.61 |
| Sham Gabapentin | 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) | Visit 7 Cold | 26.25 degree celsius | Standard Deviation 3.96 |
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)
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.
Time frame: 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.
Population: Enrolled participants who didn't withdraw, were not withdrawn by the investigator.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| True Acupuncture | 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) | Visit 4 tolerance to 47 celsius heat simulation | 28.36 Seconds | Standard Deviation 26.67 |
| True Acupuncture | 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) | visit 4 cold pain threshold | 3.72 Seconds | Standard Deviation 6.95 |
| True Acupuncture | 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) | visit 4 heat pain threshold | 49.53 Seconds | Standard Deviation 1.96 |
| True Acupuncture | 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) | visit 1 cold pain threshold | 5.16 Seconds | Standard Deviation 6.78 |
| True Acupuncture | 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) | visit 1 heat pain threshold | 48.95 Seconds | Standard Deviation 2.86 |
| True Acupuncture | 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) | visit 7 cold pain threshold | 2.7 Seconds | Standard Deviation 4.36 |
| True Acupuncture | 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) | visit 7 heat pain threshold | 49.57 Seconds | Standard Deviation 2.39 |
| True Acupuncture | 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) | Visit 1 tolerance to 47 celsius heat simulation | 27.86 Seconds | Standard Deviation 25.39 |
| True Acupuncture | 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) | Visit 7 tolerance to 47 celsius heat simulation | 29.28 Seconds | Standard Deviation 25.55 |
| Sham Acupuncture | 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) | visit 1 heat pain threshold | 49.93 Seconds | Standard Deviation 2.39 |
| Sham Acupuncture | 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) | visit 1 cold pain threshold | 4.7 Seconds | Standard Deviation 6.82 |
| Sham Acupuncture | 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) | Visit 1 tolerance to 47 celsius heat simulation | 27.56 Seconds | Standard Deviation 24.15 |
| Sham Acupuncture | 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) | visit 4 heat pain threshold | 50.39 Seconds | Standard Deviation 1.46 |
| Sham Acupuncture | 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) | visit 4 cold pain threshold | 2.1 Seconds | Standard Deviation 4.43 |
| Sham Acupuncture | 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) | Visit 4 tolerance to 47 celsius heat simulation | 29.1 Seconds | Standard Deviation 24.85 |
| Sham Acupuncture | 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) | visit 7 heat pain threshold | 50.34 Seconds | Standard Deviation 1.56 |
| Sham Acupuncture | 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) | visit 7 cold pain threshold | 2.38 Seconds | Standard Deviation 6.42 |
| Sham Acupuncture | 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) | Visit 7 tolerance to 47 celsius heat simulation | 32.06 Seconds | Standard Deviation 22.43 |
| Gabapentin | 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) | visit 4 cold pain threshold | 7.09 Seconds | Standard Deviation 8.53 |
| Gabapentin | 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) | Visit 1 tolerance to 47 celsius heat simulation | 29.59 Seconds | Standard Deviation 28.43 |
| Gabapentin | 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) | visit 1 heat pain threshold | 49.59 Seconds | Standard Deviation 2.49 |
| Gabapentin | 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) | Visit 4 tolerance to 47 celsius heat simulation | 23.69 Seconds | Standard Deviation 26.44 |
| Gabapentin | 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) | Visit 7 tolerance to 47 celsius heat simulation | 29.07 Seconds | Standard Deviation 29.28 |
| Gabapentin | 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) | visit 7 heat pain threshold | 49.8 Seconds | Standard Deviation 2.01 |
| Gabapentin | 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) | visit 1 cold pain threshold | 3.89 Seconds | Standard Deviation 8.58 |
| Gabapentin | 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) | visit 7 cold pain threshold | 8.18 Seconds | Standard Deviation 9.38 |
| Gabapentin | 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) | visit 4 heat pain threshold | 48.71 Seconds | Standard Deviation 2.91 |
| Sham Gabapentin | 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) | Visit 1 tolerance to 47 celsius heat simulation | 23.63 Seconds | Standard Deviation 24.4 |
| Sham Gabapentin | 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) | Visit 7 tolerance to 47 celsius heat simulation | 24.85 Seconds | Standard Deviation 26.13 |
| Sham Gabapentin | 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) | visit 1 heat pain threshold | 48.95 Seconds | Standard Deviation 4.02 |
| Sham Gabapentin | 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) | visit 7 cold pain threshold | 5.7 Seconds | Standard Deviation 9.39 |
| Sham Gabapentin | 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) | Visit 4 tolerance to 47 celsius heat simulation | 25.23 Seconds | Standard Deviation 26.49 |
| Sham Gabapentin | 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) | visit 1 cold pain threshold | 6.8 Seconds | Standard Deviation 9.68 |
| Sham Gabapentin | 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) | visit 4 cold pain threshold | 7.05 Seconds | Standard Deviation 9.45 |
| Sham Gabapentin | 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) | visit 4 heat pain threshold | 48.55 Seconds | Standard Deviation 3.79 |
| Sham Gabapentin | 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) | visit 7 heat pain threshold | 48.40 Seconds | Standard Deviation 3.74 |