Electrical stimulation of acupuncture points for low back pain relief

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

This study is testing if a new way of using electrical stimulation on acupuncture points can help people with chronic low back pain feel better and move more easily.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The University of Hong Kong (Academic / other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT04809909 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of peripheral nerve field stimulation (PNFS) combined with acupuncture techniques to alleviate chronic low back pain. It involves 50 participants who will be randomly assigned to receive either peripheral stimulation of acupuncture points (PSAP) or PNFS. The PSAP group will have electrodes implanted to stimulate specific acupuncture points, while the PNFS group will have electrodes implanted to target the painful area directly. The goal is to assess pain reduction and improvement in physical functioning through this innovative approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic, intractable low back pain lasting at least six months.

Not a fit: Patients currently receiving spinal cord stimulation or those with certain implantable devices may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new, effective treatment option for patients suffering from chronic low back pain.

How similar studies have performed: Previous studies have shown that peripheral nerve field stimulation is effective for pain relief, suggesting potential success for this novel combined approach.

Eligibility criteria

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.

Where this trial is running

Hong Kong

• Department of Anaesthesiology, The University of Hong Kong — Hong Kong, China (Recruiting)

Study contacts

• Study coordinator: Chi Wai Cheung, MD

Conditions Low Back Pain