Lumbar Muscle Strain
Conditions
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.
Interventions
PROCEDUREacupuncture
The needles are inserted into the subject in a certain way to stimulate specific parts of the body to treat the disease.
Sponsors
Xu Xinnan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Contacts
Primary ContactXinnan Xu
Backup ContactYongliang Jiang
Outcome results
None listed