Study on the Effect of Electronic Moxibustion on Non-Specific Low Back Pain in Young Adults

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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);

Trial design

Design model

Crossover

Treatments tested in this trial

  • Electronic Moxibustion

    Other intervention

    The subjects were equally divided into the experimental group and the control group. The experimental group received electronic moxibustion 5 times a week for 4 weeks, used painkillers when experiencing subjective pain, and uploaded check-in records.

  • ibuprofen or celecoxib analgesics

    Drug

    The control group took oral painkillers when experiencing subjective pain and uploaded check-in records.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Electronic Moxibustion GroupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Drug dosage

Total consumption of painkillers during the two groups of trials (within four weeks).

Time frame
Starting from the measurement baseline until the end of the 4-week intervention period, the difference in medication dosage used by the two groups during the intervention will be evaluated.

Secondary outcomes

Other outcomes

Sponsors and contacts

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