| Registry | NCT07858188 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: none, treatment |
| Enrollment | 90 (Estimated) |
| Sponsor | Nanfang Hospital, Southern Medical University (Other) |
| Conditions | Electronic Moxibustion, Low Back Pain, Muscle Hardness |
| Interventions | Electronic Moxibustion, ibuprofen or celecoxib analgesics (Other, drug) |
| Dates | start 2026-09-01 (estimated), primary completion 2027-09-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-10-05, last updated 2026-10-05 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Electronic Moxibustion All trials for Low Back Pain All trials of Electronic Moxibustion All trials of ibuprofen or celecoxib analgesics
This is an interventional clinical study. A total of 90 subjects aged 18 to 40 years are planned to be recruited. The subjects have low back pain that affects daily work and life, resulting in reduced exercise tolerance or aggravated pain after exercise, while retaining basic living ability and being capable of performing partial activities; their VAS scores range from 4 to 6. At baseline, the duration of subjects' low back pain and disability index will be recorded, along with muscle stiffness and electroencephalogram findings. Afterwards, electronic moxibustion treatment will be administered for 4 weeks. Subjects will be randomly divided into a treatment group and a control group with equal numbers of participants. The treatment group will use a Wenyang instrument with a rated frequency of 50 Hz, with the temperature set between 40℃ and 60℃ based on subjects' comfort level. Each treatment session lasts 30 to 60 minutes, 5 times per week for 4 weeks. The Wenyang instrument is used by subjects at home, with researchers providing remote guidance and supervision via voice or video. Subjects will check in and upload records after each use of electronic moxibustion, which will be documented by researchers. If subjects suffer from unbearable low back pain during the study, they may take oral ibuprofen or celecoxib for pain relief. The dosage and administration time will be recorded, and check-in and upload will be completed after each dose of analgesics for researchers' documentation. Subjects in the control group will take oral ibuprofen or celecoxib for pain relief as needed (i.e., when they feel pain). The dosage and administration time will be recorded with check-in and upload. After 4 weeks of intervention, the two groups will be compared in terms of the number of days of analgesic use or total consumed dosage, as well as changes in VAS scores, disability index, muscle stiffness and electroencephalogram findings.
This is an interventional clinical study. A total of 90 subjects aged 18 to 40 years are planned to be recruited. The subjects have low back pain that affects daily work and life, resulting in reduced exercise tolerance or aggravated pain after exercise, while retaining basic living ability and being capable of performing partial activities; their VAS scores range from 4 to 6. At baseline, the duration of subjects' low back pain and disability index will be recorded, along with muscle stiffness and electroencephalogram findings. Afterwards, electronic moxibustion treatment will be administered for 4 weeks. Subjects will be randomly divided into a treatment group and a control group with equal numbers of participants. The treatment group will use a Wenyang instrument with a rated frequency of 50 Hz, with the temperature set between 40℃ and 60℃ based on subjects' comfort level. Each treatment session lasts 30 to 60 minutes, 5 times per week for 4 weeks. The Wenyang instrument is used by subjects at home, with researchers providing remote guidance and supervision via voice or video. Subjects will check in and upload records after each use of electronic moxibustion, which will be documented by researchers. If subjects suffer from unbearable low back pain during the study, they may take oral ibuprofen or celecoxib for pain relief. The dosage and administration time will be recorded, and check-in and upload will be completed after each dose of analgesics for researchers' documentation. Subjects in the control group will take oral ibuprofen or celecoxib for pain relief as needed (i.e., when they feel pain). The dosage and administration time will be recorded with check-in and upload. After 4 weeks of intervention, the two groups will be compared in terms of the number of days of analgesic use or total consumed dosage, as well as changes in VAS scores, disability index, muscle stiffness and electroencephalogram findings.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Electronic Moxibustion Group | Experimental | Other: Electronic Moxibustion | The experimental group used a Yang-warming instrument with a rated frequency of 50 Hz. The temperature was set at 40-60 °C, adjusted mainly according to the subject's comfort level. Each treatment lasted 30-60 minutes, with 5 sessions per week for 4 consecutive weeks. Subjects used the Yang-warming instrument at home, and researchers provided remote guidance and supervision via voice or video calls. Subjects checked in and uploaded records after each session of electronic moxibustion, which were documented by researchers. If subjects experienced unbearable lumbago during the study, they could take oral ibuprofen or celecoxib for pain relief. The dosage and time of medication were recorded, and check-in records were uploaded after each painkiller administration for researchers' documentation. |
| control group | Active comparator | Drug: ibuprofen or celecoxib analgesics | In the control group, subjects took oral ibuprofen or celecoxib analgesics at an unspecified time (i.e., when the subjects felt pain). The dosage and time of medication were recorded and uploaded via check-in. |
Sex: All, ages: 18 Years to 40 Years
Inclusion Criteria: * Agree to participate in the study and voluntarily sign the informed consent form; * Typically developing young adults aged 18-40 years of any gender, with a VAS score between 4 and 6 inclusive; * Symptoms include low back pain aggravated by cold, difficulty turning, dark tongue with white greasy coating (cold-dampness and blood stasis pattern); stabbing pain with fixed location, tenderness on pressure, worse at night and milder in the daytime (blood stasis low back pain); dull lingering low back pain with soreness and weakness, persistent symptoms, local cold sensation, preference for warmth and pressure, worsening upon cold exposure, cold limbs (kidney-yang deficiency low back pain); * No history of spinal surgery, nerve root compression or severe organic diseases. Exclusion Criteria: * Pregnancy, broken skin or abnormal temperature sensation; * Organic diseases such as lumbar disc herniation, fractures and tumors; * Received acupuncture, tuina or analgesic treatment within the past month; * Combined with mental illness or brain injury (affecting EEG); * Considered unsuitable for participation in this study as judged by the researchers.
| Facility | City | Country | Status |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Guangzhou, Guangdong | China |