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

NCT ID: NCT06286969

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-03-01

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.

Conditions

Lumbar Muscle Strain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: PROCEDURE

The needles are inserted into the subject in a certain way to stimulate specific parts of the body to treat the disease.

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.

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: PROCEDURE

The needles are inserted into the subject in a certain way to stimulate specific parts of the body to treat the disease.

Interventions

acupuncture

The needles are inserted into the subject in a certain way to stimulate specific parts of the body to treat the disease.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xu Xinnan

OTHER

Sponsor Role: lead

Responsible Party

Xu Xinnan

medical student

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Xinnan Xu

Role: CONTACT

Phone: 18358517573

Email: 202211121211324@zcmu.edu.cn

Yongliang Jiang

Role: CONTACT

Phone: 13858173136

Email: jyl2182@126.com

Other Identifiers

ZSLL-ZN-2024-007-01

Identifier Type: -

Identifier Source: org_study_id