The Palliative Effect of TENS-WAA on 'Capsaicin/Heat' Induced Acute Lower Back Pain: a Self-controlled Clinical Study

NCT06944665 | Not Yet Recruiting DMC

• 1 other identifier: CHEC2025-005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Acute lower back pain is a common condition that occurs in all age groups, and most people will experience acute lower back pain at least once in their lives. The use of pharmacological analgesic interventions may result in complications such as gastrointestinal reactions, skin reactions, and renal damage, so there is an urgent need for an analgesic method that is easy to use, relatively safe, and has no significant systemic side effects to alleviate patients' pain. Wrist and ankle acupuncture is an acupuncture therapy developed by Professor Zhang Xinshu and other professors of the First Affiliated Hospital of the Second Military Medical University of the Chinese People's Liberation Army based on the meridian theory of Chinese medicine, by dividing the human body into two segments and six zones and treating them according to the longitudinal zones in which the illnesses are located or the corresponding points of the areas where the primary lesions are located, in order to achieve the purpose of dredging the meridians and collaterals, regulating qi and blood, balancing the yin and yang, relieving pain and treating the illnesses, and it has been widely used for treating the clinical It is widely used to treat all kinds of pain and neurological diseases. Transcutaneous Electrical Nerve Stimulation is a non-invasive pain treatment method, which relieves pain by distributing current of specific frequency and intensity to stimulate peripheral nerves. In recent years, our team has combined the wrist and ankle needles with transcutaneous electrical nerve stimulation to develop an analgesic device that can be worn on the human wrist and ankle, which is called transcutaneous electrical nerve stimulation based on the theory of wrist and ankle needles. Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA) uses low-frequency electronic pulses to stimulate the entry point of the wrist-ankle acupuncture needle, which has the advantages of easy to wear, concentrated treatment site, safe treatment, and needle-free. Functional near-infrared spectroscopy is a novel optical technique for non-invasive brain activity measurement by reading cerebral haemodynamics and oxygen saturation. Advantages include portability, non-invasiveness, no ionising radiation or drug injections, and simultaneous measurement of two haemodynamic parameters - deoxyhaemoglobin and oxyhaemoglobin. Several studies have demonstrated the utility and potential of functional NIR spectroscopy for pain assessment. In medical research, the capsaicin model is widely used to simulate acute pain in humans, and capsaicin-induced pain sensations are produced primarily through binding to capsaicin receptors. Topical application of capsaicin activates TRPV1, located at the end of primary sensory neurons in the trunk and viscera, which, through a series of actions, leads to the release of pro-inflammatory factors, while injury receptors in the skin then generate neural signals that are transferred to the cerebral cortex, resulting in the sensation of pain. The sensation is similar to neuropathic pain, and pro-inflammatory factors also play a key role in the pathophysiological process of acute lower back pain. Therefore, the use of capsaicin is effective in inducing acute lower back pain, while related studies have shown that the combination of heat and capsaicin has a synergistic or additive effect. The present study was designed as an autocross-control study in which a 'capsaicin-thermal pain' low back model was established in healthy subjects to induce acute lower back pain, and the analgesic efficacy of TENS-WAA was verified by using the fNIRS, VAS, and other assessment methods, with the following main objectives:

1. 1.To repeat the validity of the pre-cortical fNIRS pain assessment paradigm in a controlled study;
2. 2.To validate the efficacy of the Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory intervention in an autocross-control study by using fNIRS to collect data on changes in blood oxygen levels in brain regions involved in pain perception (frontal pole area and dorsolateral prefrontal cortex), as well as the VAS;
3. 3.Explore the specificity of Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory acupoints through the self-randomised crossover control of 'unilateral pain + ipsilateral intervention' and 'unilateral pain + contralateral intervention'.

Conditions

Acute Low Back Pain

Outcome Measures

Primary Outcomes (1)

• functional near-infrared spectroscopy

  Throughout the entire experimental procedure (up to 50 minutes)

Secondary Outcomes (3)

• Short-Form McGill Pain Questionnaire

  at 10 minutes post capsaicin/heat-induced pain modeling ,at 10 minutes post electrical stimulation ,at 20 minutes post electrical stimulation

• Oxygen

  Throughout the entire experimental procedure (up to 50 minutes)

• heart rate

  Throughout the entire experimental procedure (up to 50 minutes)

Study Arms (2)

Left

EXPERIMENTAL

At the time of the first phase of the trial: analgesic intervention in the left lower ankle after capsaicin/heat pain modelling in the left subject area adjacent to the 2nd-4th lumbar vertebrae in the Left1 group of subjects.At the time of the second phase of the trial: analgesic intervention in the left lower ankle after capsaicin/heat pain modelling in the right subject area adjacent to the 2nd-4th lumbar vertebrae in the Left group of subjects.

Device: Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory

Right

EXPERIMENTAL

At the time of the first phase of the trial: subjects in the Right1 group underwent analgesic intervention in the right lower ankle after capsaicin/heat pain modelling in the right subject area adjacent to the 2nd-4th lumbar vertebrae.At the time of the second phase of the trial: subjects in the Right1 group underwent analgesic intervention in the right lower ankle after capsaicin/heat pain modelling in the left subject area adjacent to the 2nd-4th lumbar vertebrae.

Device: Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory

Interventions

Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory DEVICE

Based on the theory of wrist and ankle needles, transcutaneous electrical nerve stimulation is a kind of analgesic treatment device that combines wrist and ankle needles with transcutaneous electrical nerve stimulation, and can be worn on the human wrist and ankle. Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture Theory uses low-frequency electronic pulses to stimulate the entry point of the wrist-ankle needle, which has the advantages of easy to wear, concentration of the treatment site, safety of the treatment, and no needles.

Left; Right

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males between the ages of 18-44 years;
• The dominant hand is the right hand;
• No persistent pain in the last month;
• No acute pain in the last week;
• Good health with no medical condition for which he/she is receiving treatment;
• Subjects agreed to participate in this trial and signed an informed consent form.

You may not qualify if:

• With malignant tumours and serious heart, liver and kidney diseases;
• Those with skin breakage at the site of capsaicin application;
• Those with a history of lumbar spine surgery, spinal fracture, rheumatic disease, cancer, pacemaker, or congenital anomalies of the spine;
• Any other medical condition that may affect pain perception, including neurological and psychiatric disorders;
• Taking sedative and sleep-aiding drugs within one week;
• Those who are allergic to capsaicin;
• Currently participating in another clinical trial concerning lower back pain or pain.

Sponsors & Collaborators

• Xiaonan Huang: lead

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Central Study Contacts

siyu guo

CONTACT

+8618345293402; gsy1834529@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 25, 2025
• Study Start: May 5, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 31, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-01

Locations

CN (1)