Clinical trial NCT04809909: Peripheral Stimulation of Acupuncture Points for Low Back Pain
Official title: Effect of Peripheral Stimulation on Acupuncture Points for Pain Relief of Low Back Pain Patients - a Prospective, Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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 life. However, currently, there is still no "gold standard" treatment for cure of the problem.

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.

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.

Primary outcomes:
measure: Pain intensity
timeFrame: at 2 weeks after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Anaesthesiology, The University of Hong Kong
Study officials:
References: