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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
108
The needles are inserted into the subject in a certain way to stimulate specific parts of the body to treat the disease.
clinical efficacy evaluation criteria
It was evaluated according to the efficacy standard of lumbar muscle strain injury in the Guidelines for Clinical Research of New Chinese Medicines, and the JOA index was used as the benchmark: Efficacy index (N) = \[(pre-treatment score - post-treatment score) ÷ pre-treatment score\] × 100% * cure: the patient does not feel obvious back pain and other discomforts, N ≥ 90% * Effective: Effective: low back pain is significantly relieved, 60% ≤ N \< 90% ③ Effective: lower back pain is relieved, 30%≤N\<60%. ④ Ineffective: the patient's low back pain is not relieved, N\<30%. Total effective rate (%) = \[(number of cured + number of effective + number of effective) ÷ number of cases in each group\] × 100%.
Time frame: Outcomes will be assessed after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.
Pain visual analog scale (VAS) score
The visual analogue scale (VAS) is used for pain assessment. The basic method is to use a traveling scale of about 10 cm in length, with 10 scales on one side and "0" and "10" scores at each end, with 0 indicating no pain and 10 representing the most severe pain that is intolerable.
Time frame: Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.
Japanese Orthopaedic Association Scores
JOA refers to the Japanese Orthopaedic Association Assessment Treatment Score, which is primarily used to evaluate functional impairment in the human body.The total JOA score ranges from a maximum of 29 to a minimum of 0. The lower the score, the more pronounced the functional impairment. Lower scores indicate more significant dysfunction.
Time frame: Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.
Lumbar Joint Mobility Measurement Scale
The lumbar mobility test is an examination of the mobility of the lumbar region. The tester is asked to perform forward flexion, backward extension, lateral flexion, and rotational movements to assess the degree of limitation of lumbar mobility.
Time frame: Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.
Improvement of the Ashworth Rating Scale
The Modified Ashworth Grading Scale assesses the degree of spasticity of the lumbar muscles by measuring muscle tone during exercise.
Time frame: Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.
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