Peripheral Stimulation of Acupuncture Points for Low Back Pain

Effect of Peripheral Stimulation on Acupuncture Points for Pain Relief of Low Back Pain Patients - a Prospective, Double-blind Randomized Controlled Trial

For decades, chronic low back pain has been one of the major health complaints in Hong Kong. Without proper management, low back pain is associated with functional disability and decreased quality of life. However, currently, there is still no "gold standard" treatment for cure of the problem.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Peripheral stimulation of acupuncture points (PSAP); Procedure: Peripheral nerve field stimulation (PNFS)

Detailed Description

Peripheral nerve field stimulation (PNFS) is a neuromodulation therapy which provides pain relief through electrical stimulation of the painful area at the lower back. Previous studies have shown that the use of PNFS is effective in reducing pain intensity and improving physical functioning.

Peripheral stimulation of acupuncture points (PSAP) is a novel therapeutic strategy which involves the combination of PNFS and acupuncture from traditional Chinese medicine. Through electrical stimulation of specific acupuncture points, synergistic effect and additional benefits such as relief of sciatica might be observed. As such, the intervention is of our interest in the study.

The study will involve 50 subjects. After signing the consent form, subjects will be randomly assigned to one of the two groups, either PSAP or PNFS.

For group PSAP, two electrode leads will be implanted and connected to an external neurostimulator for electrical stimulation of acupuncture points.

For group PNFS, two electrode leads will be implanted and connected to an external neurostimulator for electrical stimulation of the painful area.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chi Wai Cheung, MD; Phone Number: 22553303; Email: cheucw@hku.hk

Study Locations

• China
  • Hong Kong, China
    • Recruiting
    • Department of Anaesthesiology, the University of Hong Kong
    • Contact: Chi Wai Cheung, MBBS, MD; Phone Number: 852-22553303; Email: cheucheucw@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient has signed the Subject Informed Consent/Subject Information Sheet prior to randomization.
2. Patient is aged 18 or above at the time of informed consent.
3. Patient presents with chronic intractable non-specific, axial or radicular Low Back Pain.
4. Patient has had chronic pain for at least 6 months.
5. Patient presents with predominant back pain, with a back pain score of ≥ 5 on the 11-point Numerical Rating Scale (NRS).
6. For patients with radicular Low Back Pain, the severity of back pain is greater than or equal to that of leg pain.
7. In the opinion of the Principal Investigator, the patient's Low Back Pain is regarded as intractable, as defined by the failure of at least three different classes of Low Back Pain treatments (pharmaceutical and/or non-pharmaceutical).

Exclusion Criteria:

1. Patient has been or is currently being treated with spinal cord stimulation or an implantable intrathecal drug delivery system.
2. Patient has an implantable infusion pump or a cardiac pacemaker.
3. In the opinion of the Principal Investigator, the patient's painful area overlaps with the predetermined acupuncture point used in the study.
4. Patient has a life expectancy of less than one year.
5. Patient has an active psychiatric disorder that is likely to hinder assessment of pain-related outcomes and/or compliance with the study protocol.
6. Patient has a systemic infection or lupus erythematosus.
7. Patient has a history of coagulation disorder.
8. Patient has enrolled in or is planning to enrol in clinical trials that might confound the results of the study.
9. Patient is currently pregnant or planning to become pregnant in the following 12 months.
10. Patient has knowledge of acupuncture and knows the location of acupuncture sites for pain relief.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peripheral stimulation of acupuncture points (PSAP); Two electrode leads will be implanted and connected to an external neurostimulator for electrical stimulation of acupuncture points.	Procedure: Peripheral stimulation of acupuncture points (PSAP); Electrode leads will be implanted at Bladder 25-bilateral (BL25), the acupoint commonly used for relief of chronic Low Back Pain in standardized acupuncture.
Active Comparator: Peripheral nerve field stimulation (PNFS); Two electrode leads will be implanted and connected to an external neurostimulator for electrical stimulation of the painful area.	Procedure: Peripheral nerve field stimulation (PNFS); Electrode leads will be implanted at the region of pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Patient rates the pain intensity on the eleven-point scale from 0 to 10, in which 0 represents an absense of pain while 10 indicates the worst imaginable pain。	at 2 weeks after procedure

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): November 5, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: UW21-024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No