Clinical Study on Intensive Multi-acupuncture in the Treatment of Lumbar Muscle Strain.

Not Applicable

Not yet recruiting

• Conditions: Lumbar Muscle Strain

• Registration Number: NCT06286969
• Lead Sponsor: Xu Xinnan

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-24
• Study First Submitted QC: 2024-02-24
• Last Update Submitted: 2024-02-24
• Study First Posted: 2024-02-29
• Last Update Posted: 2024-02-29
• Study Start: 2024-03-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
clinical efficacy evaluation criteria	Outcomes will be assessed after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.	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%.

Secondary Outcome Measures

Name	Time	Method
Lumbar Joint Mobility Measurement Scale	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 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.
Improvement of the Ashworth Rating Scale	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 Modified Ashworth Grading Scale assesses the degree of spasticity of the lumbar muscles by measuring muscle tone during exercise.
Pain visual analog scale (VAS) score	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 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.
Japanese Orthopaedic Association Scores	Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.	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.