Acute Low Back PainNCT06944665
The Palliative Effect of TENS-WAA on 'Capsaicin/Heat' Induced Acute Lower Back Pain: a Self-controlled Clinical Study
A study testing Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory in people with Acute Low Back Pain, run by Xiaonan Huang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Low Back Pain
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Guo, +8618345293402, gsy1834529@163.com
About this study
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.
Read more
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:
- To repeat the validity of the pre-cortical fNIRS pain assessment paradigm in a controlled study;
- 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;
- 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'.
Read the detailed description
Content of the study Phase 1 trial: subjects were randomly divided into Left1 group (n=15) and Right1 group (n=15), subjects in the Left1 group were intervened in the left lower ankle after capsaicin/heat pain modelling in the left region adjacent to the lumbar vertebrae of L2-L4; subjects in the Right1 group were intervened in the right lower ankle after capsaicin/heat pain modelling in the right region adjacent to the lumbar vertebrae of L2-L4. Intervention.
Phase 2 trial: subjects in the Left1 and Right1 groups of the Phase 1 trial were crossed over, i.e., the Left1 group was assigned to the Right2 group and the Right1 group was assigned to the Left2 group. the Left2 group intervened in the right lower ankle after capsaicin/heat pain modelling was established in the left region adjacent to the lumbar vertebrae of L2-L4, and the Right2 group intervened in the right lower ankle in the right region adjacent to the lumbar vertebrae of L2-L4. After establishing the capsaicin/heat pain model, the intervention was performed on the left lower ankle.
Research Methods
- Experimental environment A quiet, dark and undisturbed indoor environment was selected, with a constant room temperature of 26°C, and the subjects were kept in a sitting position throughout the experiment to facilitate the acquisition of functional near infrared spectroscopy (fNIRS) signals.
- Test materials Functional near infrared spectroscopy (fNIRS) signal acquisition equipment, transcutaneous electrical nerve stimulation equipment based on the theory of carpal and ankle needling, capsaicin cream (CAPZASIN-HP, 0.1% capsaicin), medical alcohol disinfectant wet wipes, cling film, and temperature-controlled hot packs.
- Capsaicin sensitivity test Capsaicin sensitivity test was first performed on the included subjects by applying capsaicin cream on the inner left forearm of the subjects 1cm×1cm, with a thickness of about 1mm. retaining the capsaicin for 5min, and subjects with allergic reactions and capsaicin intolerance were excluded from the test.
- Lower back capsaicin-heat pain model In this experiment, the capsaicin-thermal pain model was established by applying hot compresses with capsaicin cream: capsaicin cream (CAPZASIN-HP, 0.1% capsaicin) was applied to two symmetrical areas of 5 cm × 10 cm on either side of the alcohol sterilised lumbar paraspinal region of L2-L4, at a thickness of approximately 2 mm, and covered with cling film, and a hot compress bag with a constant temperature of 40°C was used to apply hot compresses on the area for for 10 minutes, and the application position was as shown in Figure 1. Capsaicin was retained throughout and wiped off at the end of the trial.
- Methods Using an own-crossover controlled study, subjects (n=30) included in the trial were subjected to two phases of the trial, separated by a washout period of more than 7 days. Before the start of the trial, the subjects were educated about the trial process and pain assessment methods. The transcutaneous electrical nerve stimulation (TENS-WAA) action site based on the theory of wrist and ankle acupuncture (TENS-WAA) was selected from the lower 5 or 6 sites on the lateral side of the ankle according to the records of Practical Wrist and Ankle Acupuncture and literature references, which can treat low back pain, lumbar spine and paravertebral pain, and sciatica.
- Conditions
- Acute Low Back Pain
- Being tested
- Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theoryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional near-infrared spectroscopy
Measured: Throughout the entire experimental procedure (up to 50 minutes)
Secondary outcomes (3)
Short-Form McGill Pain Questionnaire
The Simplified McGill Pain Questionnaire includes three items: The first is the Pain Rating Index (PRI), which encompasses 11 sensory descriptors and 4 affective descriptors. Each term is scored on a scale of 0-3 based on pain intensity, with a maximum score of 45 and a minimum of 0 (higher scores indicate greater pain).
The second item is the Visual Analog Scale (VAS), primarily consisting of a 10 cm line where 0 represents "no pain at all" and 10 signifies "the worst pain imaginable," with higher scores indicating greater pain.
The third item is the Present Pain Intensity (PPI), categorized into 6 levels: 0 = no pain, 1 = mild, 2 = discomforting, 3 = distressing, 4 = horrible, 5 = excruciating.
Measured: at 10 minutes post capsaicin/heat-induced pain modeling ,at 10 minutes post electrical stimulation ,at 20 minutes post electrical stimulation
Oxygen
Measured: Throughout the entire experimental procedure (up to 50 minutes)
heart rate
Measured: Throughout the entire experimental procedure (up to 50 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start5 May 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaonan Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaonan Huang, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944665
- Sponsor's protocol ID
- CHEC2025-005
- Status last verified
- Jan 2025
- First submitted
- 9 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Palliative Effect of TENS-WAA on 'Capsaicin/Heat' Induced Acute Lower Back Pain: a Self-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06944665
- Acronym / sponsor ID
- CHEC2025-005
- Conditions
- Acute Low Back Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xiaonan HuangUniversity, hospital or other
- Study start
- 5 May 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To repeat the validity of the pre-cortical fNIRS pain assessment paradigm in a controlled study;
- 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;
- 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'.
Detailed description
Content of the study Phase 1 trial: subjects were randomly divided into Left1 group (n=15) and Right1 group (n=15), subjects in the Left1 group were intervened in the left lower ankle after capsaicin/heat pain modelling in the left region adjacent to the lumbar vertebrae of L2-L4; subjects in the Right1 group were intervened in the right lower ankle after capsaicin/heat pain modelling in the right region adjacent to the lumbar vertebrae of L2-L4. Intervention.
Phase 2 trial: subjects in the Left1 and Right1 groups of the Phase 1 trial were crossed over, i.e., the Left1 group was assigned to the Right2 group and the Right1 group was assigned to the Left2 group. the Left2 group intervened in the right lower ankle after capsaicin/heat pain modelling was established in the left region adjacent to the lumbar vertebrae of L2-L4, and the Right2 group intervened in the right lower ankle in the right region adjacent to the lumbar vertebrae of L2-L4. After establishing the capsaicin/heat pain model, the intervention was performed on the left lower ankle.
Research Methods
- Experimental environment A quiet, dark and undisturbed indoor environment was selected, with a constant room temperature of 26°C, and the subjects were kept in a sitting position throughout the experiment to facilitate the acquisition of functional near infrared spectroscopy (fNIRS) signals.
- Test materials Functional near infrared spectroscopy (fNIRS) signal acquisition equipment, transcutaneous electrical nerve stimulation equipment based on the theory of carpal and ankle needling, capsaicin cream (CAPZASIN-HP, 0.1% capsaicin), medical alcohol disinfectant wet wipes, cling film, and temperature-controlled hot packs.
- Capsaicin sensitivity test Capsaicin sensitivity test was first performed on the included subjects by applying capsaicin cream on the inner left forearm of the subjects 1cm×1cm, with a thickness of about 1mm. retaining the capsaicin for 5min, and subjects with allergic reactions and capsaicin intolerance were excluded from the test.
- Lower back capsaicin-heat pain model In this experiment, the capsaicin-thermal pain model was established by applying hot compresses with capsaicin cream: capsaicin cream (CAPZASIN-HP, 0.1% capsaicin) was applied to two symmetrical areas of 5 cm × 10 cm on either side of the alcohol sterilised lumbar paraspinal region of L2-L4, at a thickness of approximately 2 mm, and covered with cling film, and a hot compress bag with a constant temperature of 40°C was used to apply hot compresses on the area for for 10 minutes, and the application position was as shown in Figure 1. Capsaicin was retained throughout and wiped off at the end of the trial.
- Methods Using an own-crossover controlled study, subjects (n=30) included in the trial were subjected to two phases of the trial, separated by a washout period of more than 7 days. Before the start of the trial, the subjects were educated about the trial process and pain assessment methods. The transcutaneous electrical nerve stimulation (TENS-WAA) action site based on the theory of wrist and ankle acupuncture (TENS-WAA) was selected from the lower 5 or 6 sites on the lateral side of the ankle according to the records of Practical Wrist and Ankle Acupuncture and literature references, which can treat low back pain, lumbar spine and paravertebral pain, and sciatica.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left | Experimental | Device: Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theoryAt 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. |
| Right | Experimental | Device: Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theoryAt 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theoryBased 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. | Device | Left, Right |
Primary outcome
functional near-infrared spectroscopy
Time frame: Throughout the entire experimental procedure (up to 50 minutes)
3 secondary outcomes
Short-Form McGill Pain Questionnaire
Time frame: at 10 minutes post capsaicin/heat-induced pain modeling ,at 10 minutes post electrical stimulation ,at 20 minutes post electrical stimulation
Oxygen
Time frame: Throughout the entire experimental procedure (up to 50 minutes)
heart rate
Time frame: Throughout the entire experimental procedure (up to 50 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
Related trials for Acute Low Back Pain
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
Not yet recruiting
Evaluation of a Program to Prevent Recurrences of Episodes of Acute Low Back Pain, Assisted by the Axomove Application
Low Back Pain
Recruiting
Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain.
Back Pain Lower Back Chronic
Not yet recruiting
Preventing the Transition From Acute to Persistent Disabling Low Back Pain Through Cognitive Functional Therapy
Acute Low Back Pain (Low Back Pain for Less Than 3 Months)
Recruiting
Comprehensive Biopsychosocial Approach for Acute Low Back Pain Management in the Emergency Department: a Stepped-wedge Cluster-randomized Clinical Trial
Non-traumatic Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory in people with Acute Low Back Pain, run by Xiaonan Huang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact siyu guo (+8618345293402, gsy1834529@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional near-infrared spectroscopy (time frame: Throughout the entire experimental procedure (up to 50 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.