Lumbar Muscle StrainNCT06286969
Clinical Study on Intensive Multi-acupuncture in the Treatment of Lumbar Muscle Strain.
A study testing acupuncture in people with Lumbar Muscle Strain, run by Xu Xinnan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbar Muscle Strain
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Those with severe cardiac, hepatic and renal insufficiency and those with bleeding tendency;
- 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;
- Women who are in the period of pregnancy or breastfeeding should not perform acupuncture treatment;
- Those who have needle-sickness, blood-sickness and so on;
- Those who have cognitive impairment and cannot complete the relevant scale assessment independently or under the guidance of the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Lumbar Muscle Strain
- Being tested
- acupuncture
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
The needles are inserted into the subject in a certain way to stimulate specific parts of the body to treat the disease.
| Study group | Role | What they receive |
|---|---|---|
| intensive multi-acupuncture method group | Experimental | 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. Receives: Procedure: acupuncture |
| normal needling group | Experimental | 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. Receives: Procedure: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Outcomes will be assessed after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Muscle StrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu Xinnan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu Xinnan, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286969
- Sponsor's protocol ID
- ZSLL-ZN-2024-007-01
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Lumbar Muscle Strain by Intensive Multi-acupuncture Method Based on the Principle of "Tendons Disease Pain-point Needling".
- ClinicalTrials.gov ID
- NCT06286969
- Acronym / sponsor ID
- ZSLL-ZN-2024-007-01
- Conditions
- Lumbar Muscle Strain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Xu XinnanUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intensive multi-acupuncture method group | Experimental | Procedure: acupunctureThe 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. |
| normal needling group | Experimental | Procedure: acupunctureThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- Those with severe cardiac, hepatic and renal insufficiency and those with bleeding tendency;
- 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;
- Women who are in the period of pregnancy or breastfeeding should not perform acupuncture treatment;
- Those who have needle-sickness, blood-sickness and so on;
- Those who have cognitive impairment and cannot complete the relevant scale assessment independently or under the guidance of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureThe needles are inserted into the subject in a certain way to stimulate specific parts of the body to treat the disease. | Procedure or surgery | intensive multi-acupuncture method group, normal needling group |
Primary outcome
clinical efficacy evaluation criteria
Time frame: 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%.
4 secondary outcomes
Pain visual analog scale (VAS) score
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
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
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Lumbar Muscle Strain, run by Xu Xinnan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinnan Xu (18358517573, 202211121211324@zcmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical efficacy evaluation criteria (time frame: Outcomes will be assessed after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.