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

Clinical Study on the Treatment of Lumbar Muscle Strain by Intensive Multi-acupuncture Method Based on the Principle of "Tendons Disease Pain-point Needling".

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 Overview

• Status: Not yet recruiting
• Conditions: Lumbar Muscle Strain
• Intervention / Treatment: Procedure: acupuncture

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinnan Xu; Phone Number: 18358517573; Email: 202211121211324@zcmu.edu.cn
• Study Contact Backup: Name: Yongliang Jiang; Phone Number: 13858173136; Email: jyl2182@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intensive multi-acupuncture method group; The needle entry points of the lower row are straight punctures that penetrate the muscle attachments along the medial superior margin of the posterior superior iliac spine, the medial margin of the sacroiliac joint, and a portion of the lateral iliac crest of the lumbar triangle. The entry point of the upper row of needles was made oblique, and then small lifting insertion, respectively, reached and penetrated the anterior border muscle attachments. Then subperiosteal stabbing along the bone surface was used to penetrate 1.5cm forward and downward, and the needle was retained for 15min. The needle was left in place for 15 min, and for the second puncture, the entry point was chosen to be in the middle of the two longitudinal entry points of the first puncture. The rest of the operation was unchanged. Repeat the above operation for the last 3 treatments. The treatment is performed twice a week for a total of 5 treatments.	Procedure: acupuncture; The needles are inserted into the subject in a certain way to stimulate specific parts of the body to treat the disease.
Experimental: normal needling group; The points were selected with reference to the 2006 National Standard of the People's Republic of China (GB/T 12346-2006), "Acupoint Names and Localization". The patients were placed in the prone position, the acupoints were sterilized with 75% alcohol, and the needles were inserted vertically with the conventional needling method, to the extent that there was a sensation of acidity, numbness, heaviness, distension, or radiating to the surroundings, and the needles were left in place for 15 min. The treatments were carried out twice a week for a total of five treatments.	Procedure: acupuncture; The needles are inserted into the subject in a certain way to stimulate specific parts of the body to treat the disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	Outcomes will be assessed after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.

Collaborators and Investigators

• Sponsor: Xu Xinnan

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 24, 2024
• First Submitted That Met QC Criteria: February 24, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 24, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Sprains and Strains
• Other Study ID Numbers: ZSLL-ZN-2024-007-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No