Observation of the Therapeutic Effect of Fire Needle on Upper Limb Function in Stroke Patients

NCT ID: NCT07140406

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-02
• Study Completion Date: 2025-10-31

Brief Summary

Objective: To explore the clinical efficacy of different needling strategies with moxibustion needles on upper limb function in post-stroke patients. Method: 105 patients with upper limb dysfunction after stroke were randomly divided into an extensor treatment group, a flexor treatment group, and a control group, with 35 patients in each group. Patients in the extensor treatment group were treated with extensor group moxibustion, patients in the flexor treatment group were treated with flexor group moxibustion, and patients in the control group were treated with conventional moxibustion. Observe the upper limb movement trajectory, surface electromyographic signals (sEMG) of extensor and flexor muscle groups, MAS scale scores, and FMA-UE scores of two groups of patients under specific tasks detected by a three-dimensional motion capture system before and after treatment, and determine the clinical efficacy. Result: Moxibustion therapy with moxibustion is helpful in improving upper limb dysfunction in stroke patients, safe and reliable, and worthy of application. The efficacy of needling the flexor muscle group with moxibustion is better than that of needling the extensor muscle group and conventional acupuncture, providing certain evidence and guidance for the selection of moxibustion sites in clinical practice.

Detailed Description

105 patients with upper limb dysfunction after stroke were selected according to the inclusion criteria and randomly divided into an extensor treatment group, a flexor treatment group, and a control group of 35 cases each. The patients in the extensor treatment group were treated with routine rehabilitation training+routine acupuncture and moxibustion+millifire needle acupuncture for the extensor muscle group (triceps brachii, forearm extensor muscle group), the patients in the flexor treatment group were treated with routine rehabilitation training+routine acupuncture and moxibustion+millifire needle acupuncture for the flexor muscle group (biceps brachii, forearm flexor muscle group), and the patients in the control group were treated with routine rehabilitation training+routine acupuncture and moxibustion+routine millifire needle acupuncture. The treatment was administered once every other day with a moxibustion needle for a total of 4 weeks. Observe the upper limb movement trajectory, surface electromyographic signals (sEMG) of extensor and flexor muscle groups, changes in MAS scale scores, and FMA-UE scores of two groups of patients under specific tasks detected by a three-dimensional motion capture system before, after one treatment, and after 4 weeks of treatment. Calculate joint angles and motion distances through spatial coordinates, and apply RMS MF、CC、 Coherence analysis quantifies muscle strength, muscle tension, fatigue, and coordination.

Conditions

Cerebral Infarction

Study Design

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

Study Groups

Flexed muscle Milli-fire needle

Patients in the flexor treatment group received conventional rehabilitation training, conventional acupuncture, and moxibustion with fine fire needles on the flexor muscle groups (biceps brachii and forearm flexor muscle groups).The Milli-fire needle treatment was administered every other day for a total of 4 weeks.

Group Type: EXPERIMENTAL

conventional rehabilitation training

Intervention Type: OTHER

The rehabilitation training is designed based on the specific functional conditions of the patient's limbs. The specific training methods include proper limb positioning, exercise therapy such as passive movement, anti-spasticity training, scapular girdle muscle training, joint extension training, forearm pronation and supination training, occupational therapy, joint movement training, roller treatment, and fine motor skill training, etc. The treatment is conducted once a day and five times a week. The treatment lasts for 4 consecutive weeks.

conventional acupuncture

Intervention Type: OTHER

Conventional acupuncture treatment involves needling at acupoints on the upper limbs of patients to improve their upper limb function. The treatment is administered once a day, five times a week, for a continuous period of four weeks.

Acupuncture with the milli-needle fire-puncture on flexor muscle groups

Intervention Type: OTHER

The acupuncture points of the milli-needle fire-puncture device are located in the flexor muscle groups of the upper limbs, including the biceps brachii and the flexor muscle group of the forearm.

Extensor muscle Milli-fire needle

The patients in the extensor muscle treatment group received conventional rehabilitation training , conventional acupuncture and moxibustion with Milli-fire needle on the extensor muscle groups (triceps brachii, forearm extensor muscles).The Milli-fire needle treatment was administered every other day for a total of 4 weeks.

Group Type: EXPERIMENTAL

conventional rehabilitation training

Intervention Type: OTHER

The rehabilitation training is designed based on the specific functional conditions of the patient's limbs. The specific training methods include proper limb positioning, exercise therapy such as passive movement, anti-spasticity training, scapular girdle muscle training, joint extension training, forearm pronation and supination training, occupational therapy, joint movement training, roller treatment, and fine motor skill training, etc. The treatment is conducted once a day and five times a week. The treatment lasts for 4 consecutive weeks.

conventional acupuncture

Intervention Type: OTHER

Conventional acupuncture treatment involves needling at acupoints on the upper limbs of patients to improve their upper limb function. The treatment is administered once a day, five times a week, for a continuous period of four weeks.

Acupuncture with the milli-needle fire-puncture on extensor muscle groups

Intervention Type: OTHER

The acupuncture points for the milli-needle fire-puncture device are located in the extensor muscle groups of the upper limbs, including the triceps brachii and the extensor muscles of the forearm.

Control group

Patients in the control group received conventional rehabilitation training, conventional acupuncture, and conventional moxibustion with Milli-fire needle.The acupuncture points for fire needle puncture are commonly used ones on the upper limbs.The Milli-fire needle treatment was administered every other day for a total of 4 weeks.

Group Type: ACTIVE_COMPARATOR

conventional rehabilitation training

Intervention Type: OTHER

The rehabilitation training is designed based on the specific functional conditions of the patient's limbs. The specific training methods include proper limb positioning, exercise therapy such as passive movement, anti-spasticity training, scapular girdle muscle training, joint extension training, forearm pronation and supination training, occupational therapy, joint movement training, roller treatment, and fine motor skill training, etc. The treatment is conducted once a day and five times a week. The treatment lasts for 4 consecutive weeks.

conventional acupuncture

Intervention Type: OTHER

Conventional acupuncture treatment involves needling at acupoints on the upper limbs of patients to improve their upper limb function. The treatment is administered once a day, five times a week, for a continuous period of four weeks.

Conventional needle puncture with a fire needle

Intervention Type: OTHER

The acupuncture points for milli-needle fire-puncture are commonly used ones on the upper limbs.

Interventions

conventional rehabilitation training

The rehabilitation training is designed based on the specific functional conditions of the patient's limbs. The specific training methods include proper limb positioning, exercise therapy such as passive movement, anti-spasticity training, scapular girdle muscle training, joint extension training, forearm pronation and supination training, occupational therapy, joint movement training, roller treatment, and fine motor skill training, etc. The treatment is conducted once a day and five times a week. The treatment lasts for 4 consecutive weeks.

Intervention Type: OTHER

conventional acupuncture

Conventional acupuncture treatment involves needling at acupoints on the upper limbs of patients to improve their upper limb function. The treatment is administered once a day, five times a week, for a continuous period of four weeks.

Intervention Type: OTHER

Acupuncture with the milli-needle fire-puncture on flexor muscle groups

The acupuncture points of the milli-needle fire-puncture device are located in the flexor muscle groups of the upper limbs, including the biceps brachii and the flexor muscle group of the forearm.

Intervention Type: OTHER

Acupuncture with the milli-needle fire-puncture on extensor muscle groups

The acupuncture points for the milli-needle fire-puncture device are located in the extensor muscle groups of the upper limbs, including the triceps brachii and the extensor muscles of the forearm.

Intervention Type: OTHER

Conventional needle puncture with a fire needle

The acupuncture points for milli-needle fire-puncture are commonly used ones on the upper limbs.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Meet the diagnostic criteria.

2. The patient had a first stroke and the course of disease was 15 days to 12 months.

3. With unilateral disease， the muscular tone assessed by the modified Ashworth scale of upper limb was Ⅰ/Ⅰ+/Ⅱ/Ⅲ level ，Brunnstrom stage in upper limb was Ⅲ/Ⅳ/Ⅴ， Upper limb muscle strength is greater than or equal to grade 2.

4. Age 18-70 years old.

5. Have not taken Chinese or Western medicine sedatives muscle relaxants or any drugs that have an impact on muscle tone recently.

6. Clear consciousness stable vital signs no other acute diseases and serious complications.

7. Patients or family members agree to accept this clinical study and have signed informed consent.

Exclusion Criteria

1. Bilateral disease.

2. History of serious injury or disease of other upper limb nerves muscles or bones.

3. Patients with severe cervical spondylosis and hypertension.

4. Patients with audiovisual abnormalities severe cognitive impairment and mental diseases who cannot cooperate with the examination.

5. Patients with tumor and severe malnutrition.

6. There are contraindications for needle treatment such as extreme hunger tension infectious diseases skin collapse etc.

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

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

ZhangZhaohui

Acupuncture and moxibustion therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Countries

China

Other Identifiers

KYLL-202309-045-2

Identifier Type: -

Identifier Source: org_study_id