Effect of Acupuncture and Pain Medication on Radicular Pain Using QST

Pain Clinical Trial

Official title:

Effect of Acupuncture and Pain Medication on Radicular Pain Using QST

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678586
• Other study ID #: 2012P-001795
• Secondary ID: 5R01AT005819-04
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: December 2021

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Acupuncture
In true acupuncture the needles penetrate the skin.
• Sham Acupuncture
In sham acupuncture the needles do not penetrate the skin.

Drug:
• Gabapentin
Gabapentin is a commonly prescribed drug used to treat neuropathic pain.
• 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)

Locations

Country	Name	City	State
United States	MGH Center for Translational Pain Research	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.
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.	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.

External Links

•   Center for Translational Pain Research