Predicting Analgesic Response to Acupuncture: A Practical Approach

NCT ID: NCT02890810

Last Updated: 2021-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2020-06-30

Brief Summary

In this placebo controlled, patient and assessor blinded clinical trial, the investigators will administer electroacupuncture vs sham electroacupuncture to patients suffering from chronic low back pain, and monitor their symptoms as well as collecting objective outcome measures. The investigators objective is to identify predictors of pain reduction and functional improvement with electroacupuncture vs placebo.

Conditions

Chronic Low Back Pain; Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Verum Electroacupuncture

Active Intervention

Group Type: EXPERIMENTAL

Real Acupuncture with Electrical Stimulation

Intervention Type: OTHER

Acupuncture is a therapy commonly used in East Asian countries, where the practitioner insert thin needles at specific body sites in order to relieve pain and illnesses. Recent studies found low frequency electricity applied through acupuncture needles can lead to profound pain relief by increasing endorphin levels in the central nervous system. Electroacupuncture will thus be used as the active intervention to treat chronic low back pain in this clinical study.

Placebo Electroacupuncture

Validated Control

Group Type: PLACEBO_COMPARATOR

Simulated Acupuncture with Electrical Stimulation

Intervention Type: OTHER

This intervention serves as the placebo control of the active intervention. Sterile acupuncture needles and the ITO electrical stimulators will be used in this intervention. But special care will be taken to have this intervention mimic the real treatment yet remaining as physiologically inert as possible.

Interventions

Real Acupuncture with Electrical Stimulation

Acupuncture is a therapy commonly used in East Asian countries, where the practitioner insert thin needles at specific body sites in order to relieve pain and illnesses. Recent studies found low frequency electricity applied through acupuncture needles can lead to profound pain relief by increasing endorphin levels in the central nervous system. Electroacupuncture will thus be used as the active intervention to treat chronic low back pain in this clinical study.

Intervention Type: OTHER

Simulated Acupuncture with Electrical Stimulation

This intervention serves as the placebo control of the active intervention. Sterile acupuncture needles and the ITO electrical stimulators will be used in this intervention. But special care will be taken to have this intervention mimic the real treatment yet remaining as physiologically inert as possible.

Intervention Type: OTHER

Other Intervention Names

Verum Electroacupuncture; Traditional acupuncture needles; ITO® ES-130® electrical stimulator; Sham Electroacupuncture / Placebo Electroacupuncture; Sterile Acupuncture Needles; ITO® ES-130® electrical stimulator

Eligibility Criteria

Inclusion Criteria

1. Age 21-65

2. English Fluency

3. Chronic LBP for ≥ 6 Months

1. Chronicity: cLBP "defined as a back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months."

2. Location: "between the lower posterior margin of the rib cage and the horizontal gluteal fold

4. Average pain over the last month ≥ 5/10

Exclusion Criteria

1. Radicular low back pain: defined as sharp (or burning) pain, with a defined territory, radiating down the limb, beyond the knee. Radicular pain may be accompanied by sensory and motor deficit along 1 or more dermatomes. Radicular back pain may also be accompanied by MRI evidence of intervertebral disc protrusion and compression of spinal cord and/or nerve roots.

2. Pending litigation or Worker's compensation related to the low back pain.

3. Currently pregnant or planning to become pregnant (in next 6 months)

4. American Society of Anesthesiologist (ASA) class III or above physical status. ASA class III is defined as "a patient with severe systemic disease." Examples would include poorly controlled diabetes, hypertension, COPD or morbid obesity (BMI ≥ 40).

5. Mental health conditions or treatment for mental health problems that would interfere with study procedures, at the discretion of the study team. For example, psychosis, untreated major depression, ongoing substance abuse, suicidal ideation. These will be assessed by the MINI.

6. Medications: opioids ≥60mg morphine equivalent units/day, benzodiazepines, corticosteroids.

7. Prohibited interventions: during the study period, the following are not permitted

1. Back surgeries

2. Injections with local anesthetics or steroids to the back

3. New chiropractic maneuvers

4. New physical therapy programs

5. New medications for back pain

8. Bleeding disorders at the discretion of the study team.

9. Previous acupuncture treatment in the past 10 years.

10. Medical conditions that would interfere with study procedures (eg. Heart disease or pacemaker, active infection), per discretion of the team

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Jiang-Ti Kong

Principal Investigator, Instructor - Department of Anesthesia, Pain and Perioperative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford Systems Neuroscience and Pain Lab (SNAPL)

Palo Alto, California, United States

Countries

United States

References

Kong JT, Puetz C, Tian L, Haynes I, Lee E, Stafford RS, Manber R, Mackey S. Effect of Electroacupuncture vs Sham Treatment on Change in Pain Severity Among Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2022787. doi: 10.1001/jamanetworkopen.2020.22787.

Reference Type: BACKGROUND

PMID: 33107921 (View on PubMed)

Other Identifiers

1K23AT008477-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

34754

Identifier Type: -

Identifier Source: org_study_id