Peripheral Stimulation of Acupuncture Points for Low Back Pain

NCT04809909 | Recruiting

• 1 other identifier: UW21-024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Peripheral stimulation of acupuncture points (PSAP)

EXPERIMENTAL

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)

Peripheral nerve field stimulation (PNFS)

ACTIVE COMPARATOR

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)

Interventions

Peripheral stimulation of acupuncture points (PSAP) PROCEDURE

Electrode leads will be implanted at Bladder 25-bilateral (BL25), the acupoint commonly used for relief of chronic Low Back Pain in standardized acupuncture.

Peripheral stimulation of acupuncture points (PSAP)

Peripheral nerve field stimulation (PNFS) PROCEDURE

Electrode leads will be implanted at the region of pain.

Peripheral nerve field stimulation (PNFS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Anaesthesiology, The University of Hong Kong

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chi Wai Cheung, MD

CONTACT

22553303; cheucw@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, outcome assessors and data analysts will be kept blinded to the allocation status to avoid information bias. Patients who have no knowledge in acupuncture are told that the leads would be implanted at the acupuncture points that can be at or outside the painful sites. Only the pain physician administering the allocated intervention is unblinded, whereas he/she is not involved in data collection or analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department and Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: April 1, 2021
• Primary Completion: November 5, 2025
• Study Completion: December 31, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

CN (1)