Back to resultsPeripheral Stimulation of Acupuncture Points for Low Back Pain
Primary Purpose
Low Back Pain
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Peripheral stimulation of acupuncture points (PSAP)
Peripheral nerve field stimulation (PNFS)
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
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.
Sites / Locations
- Deaprtment of Anaesthesiology, The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Peripheral stimulation of acupuncture points (PSAP)
Peripheral nerve field stimulation (PNFS)
Arm Description
Two electrode leads will be implanted and connected to an external neurostimulator for electrical stimulation of acupuncture points.
Two electrode leads will be implanted and connected to an external neurostimulator for electrical stimulation of the painful area.
Outcomes
Primary Outcome Measures
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。
Secondary Outcome Measures
Full Information
NCT ID
NCT04809909
First Posted
March 18, 2021
Last Updated
May 17, 2022
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04809909
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 5, 2022 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peripheral stimulation of acupuncture points (PSAP)
Arm Type
Experimental
Arm Description
Two electrode leads will be implanted and connected to an external neurostimulator for electrical stimulation of acupuncture points.
Arm Title
Peripheral nerve field stimulation (PNFS)
Arm Type
Active Comparator
Arm Description
Two electrode leads will be implanted and connected to an external neurostimulator for electrical stimulation of the painful area.
Intervention Type
Procedure
Intervention Name(s)
Peripheral stimulation of acupuncture points (PSAP)
Intervention Description
Electrode leads will be implanted at Bladder 25-bilateral (BL25), the acupoint commonly used for relief of chronic Low Back Pain in standardized acupuncture.
Intervention Type
Procedure
Intervention Name(s)
Peripheral nerve field stimulation (PNFS)
Intervention Description
Electrode leads will be implanted at the region of pain.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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。
Time Frame
at 2 weeks after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Deaprtment of Anaesthesiology, The University of Hong Kong
City
Hong Kong
Country
China
12. IPD Sharing Statement
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Peripheral Stimulation of Acupuncture Points for Low Back Pain
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