Status:
RECRUITING
Peripheral Stimulation of Acupuncture Points for Low Back Pain
Lead Sponsor:
The University of Hong Kong
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
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...
Eligibility Criteria
Inclusion
- Patient has signed the Subject Informed Consent/Subject Information Sheet prior to randomization.
- Patient is aged 18 or above at the time of informed consent.
- Patient presents with chronic intractable non-specific, axial or radicular Low Back Pain.
- Patient has had chronic pain for at least 6 months.
- Patient presents with predominant back pain, with a back pain score of ≥ 5 on the 11-point Numerical Rating Scale (NRS).
- For patients with radicular Low Back Pain, the severity of back pain is greater than or equal to that of leg pain.
- 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
- Patient has been or is currently being treated with spinal cord stimulation or an implantable intrathecal drug delivery system.
- Patient has an implantable infusion pump or a cardiac pacemaker.
- In the opinion of the Principal Investigator, the patient's painful area overlaps with the predetermined acupuncture point used in the study.
- Patient has a life expectancy of less than one year.
- Patient has an active psychiatric disorder that is likely to hinder assessment of pain-related outcomes and/or compliance with the study protocol.
- Patient has a systemic infection or lupus erythematosus.
- Patient has a history of coagulation disorder.
- Patient has enrolled in or is planning to enrol in clinical trials that might confound the results of the study.
- Patient is currently pregnant or planning to become pregnant in the following 12 months.
- Patient has knowledge of acupuncture and knows the location of acupuncture sites for pain relief.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04809909
Start Date
April 1 2021
End Date
December 31 2025
Last Update
May 16 2024
Active Locations (1)
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1
Department of Anaesthesiology, The University of Hong Kong
Hong Kong, China