Effect of Acupuncture and Pain Medication on Radicular Pain Using QST

NCT01678586 | Completed Results DMC

• 2 other identifiers: 2012P-0017955R01AT005819-04
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain

Keywords

Pain; Pain management

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (4)

True Acupuncture

ACTIVE COMPARATOR

Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments.

Other: Acupuncture

Sham Acupuncture

SHAM COMPARATOR

Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments.

Other: Sham Acupuncture

Gabapentin

ACTIVE COMPARATOR

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.

Drug: Gabapentin

Sham Gabapentin

SHAM COMPARATOR

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.

Drug: Sham Gabapentin

Interventions

Acupuncture OTHER

In true acupuncture the needles penetrate the skin.

True Acupuncture

Sham Acupuncture OTHER

In sham acupuncture the needles do not penetrate the skin.

Sham Acupuncture

Gabapentin DRUG

Gabapentin is a commonly prescribed drug used to treat neuropathic pain.

Also known as: Neurontin

Gabapentin

Sham Gabapentin DRUG

Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)

Also known as: Benadryl, diphenhydramine

Sham Gabapentin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

MGH Center for Translational Pain Research

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Chen L, Deng H, Houle T, Zhang Y, Ahmed S, Zhang W, Sullivan S, Opalacz A, Roth S, Filatava EJ, Stabach K, Vo T, Malarick C, Kim H, You Z, Shen S, Mao J. Comparison between acupuncture therapy and gabapentin for chronic pain: a pilot study. Acupunct Med. 2021 Dec;39(6):619-628. doi: 10.1177/09645284211026683. Epub 2021 Jul 29.

  PMID: 34325532 DERIVED

Related Links

• Center for Translational Pain Research

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Acupuncture Therapy; Gabapentin; Diphenhydramine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Ethylamines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic

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.

Results Point of Contact

• Title: Dr. Lucy Chen
• Organization: Massachusetts General Hospital

mghpainresearch@partners.org

617-724-6102

Study Officials

• Jianren Mao, M.D., Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 5, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 23, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-04

Locations

US (1)