Clinical trial NCT06286969: Clinical Study on Intensive Multi-acupuncture in the Treatment of Lumbar Muscle Strain.
Official title: Clinical Study on the Treatment of Lumbar Muscle Strain by Intensive Multi-acupuncture Method Based on the Principle of "Tendons Disease Pain-point Needling".
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lumbar Muscle Strain
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acupuncture is widely used as a routine treatment for lumbar muscle strain. The aim of this randomized controlled trial is to evaluate the effectiveness of the intensive multi-acupuncture method. This trial will include 108 patients with lumbar muscle strain injury from two outpatient clinics. All participants will be randomized in a 1:1 ratio to the intensive multi-acupuncture method group and the normal needling group. Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment. The primary outcome indicator will be the clinical efficacy evaluation criteria, and the secondary outcome indicators will be the pain visual analog scale (VAS) score, the Japanese Orthopaedic Association Assessment Treatment Score (JOA) score, the lumbar joint mobility measurement scale, and the Modified Ashworth Grading Scale. This study will provide evidence as to whether the intensive multi-acupuncture method is safe and effective.


Eligibility criteria: Inclusion Criteria:

1.Meet the above Chinese and Western medicine diagnostic criteria; 2.18 years old ≤ age ≤ 70 years old, gender is not limited; 3.The duration of the disease is more than 3 months, no other treatment has been received in the last month, and the VAS score is ≥4 at the time of participating in the treatment; 4.Voluntarily cooperate with the examination and treatment, and sign the Informed Consent Form.

Exclusion Criteria:

1. Those with severe cardiac, hepatic and renal insufficiency and those with bleeding tendency;
2. Previous history of lumbar spine surgery, spinal cauda equina tumor, lumbar spondylolisthesis, lumbar spinal stenosis, scoliosis deformity, tumors and other diseases caused by low back pain;
3. Women who are in the period of pregnancy or breastfeeding should not perform acupuncture treatment;
4. Those who have needle-sickness, blood-sickness and so on;
5. Those who have cognitive impairment and cannot complete the relevant scale assessment independently or under the guidance of the investigator.

Primary outcomes:
measure: clinical efficacy evaluation criteria
timeFrame: Outcomes will be assessed after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.
Secondary outcomes:
measure: Pain visual analog scale (VAS) score
timeFrame: Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.
measure: Japanese Orthopaedic Association Scores
timeFrame: Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.
measure: Lumbar Joint Mobility Measurement Scale
timeFrame: Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.
measure: Improvement of the Ashworth Rating Scale
timeFrame: Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.
Other outcomes:
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