Peripheral Stimulation of Acupuncture Points for Low Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Peripheral stimulation of acupuncture points (PSAP)
* Procedure: Peripheral nerve field stimulation (PNFS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The randomization sequence will be generated by Microsoft Excel software. Blocked randomization will be done with an allocation ratio of 1:1 under block randomization (patients with lower back pain only or patient having low back pain with radicular pain). The assigned intervention group is stated in sequentially numbered, opaque, sealed envelopes, which will be opened by the attending therapist treating the patient. The investigator who is involved in sequence generation or allocation concealment will not be involved in enrolling participants or administering the intervention.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripheral stimulation of acupuncture points (PSAP)<br>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)<br>* Electrode leads will be implanted at Bladder 25-bilateral (BL25), the acupoint commonly used for relief of chronic Low Back Pain in standardized acupuncture.<br>|
| Active Comparator: Peripheral nerve field stimulation (PNFS)<br>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)<br>* Electrode leads will be implanted at the region of pain.<br>|

What is the study measuring?
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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 |