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NCT Number: NCT07140406

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cerebral Infarction Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the diagnostic criteria.
  • The patient had a first stroke and the course of disease was 15 days to 12 months.
  • 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.
  • Age 18-70 years old.
  • Have not taken Chinese or Western medicine sedatives muscle relaxants or any drugs that have an impact on muscle tone recently.
  • Clear consciousness stable vital signs no other acute diseases and serious complications.
  • Patients or family members agree to accept this clinical study and have signed informed consent.

Exclusion criteria

  • Bilateral disease.
  • History of serious injury or disease of other upper limb nerves muscles or bones.
  • Patients with severe cervical spondylosis and hypertension.
  • Patients with audiovisual abnormalities severe cognitive impairment and mental diseases who cannot cooperate with the examination.
  • Patients with tumor and severe malnutrition.
  • There are contraindications for needle treatment such as extreme hunger tension infectious diseases skin collapse etc.

Treatment and study plan

conventional rehabilitation training

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

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

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.

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

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.

Conventional needle puncture with a fire needle

Other

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

Primary outcomes

  1. Root mean square(RMS) of surface electromyography(sEMG）

    Time frame: 4 weeks

    Using sEMG the EMG of the upper limb muscles is collected including RMS

Secondary outcomes

  1. RMS of sEMG

    Time frame: first day

    Using sEMG, the EMG signals of the upper limb muscles are collected, including RMS .

  2. Mean Frequency (MF)of SEMG

    Time frame: first day

    Using sEMG, the EMG signals of the upper limb muscles are collected, including MF.

  3. Joint angle

    Time frame: first day

    Three-dimensional motion capture system was used to detect joint angle .

  4. Motion distance

    Time frame: first day

    Three-dimensional motion capture system was used to detect motion distance.

  5. Joint angle

    Time frame: 4 weeks

    Three-dimensional motion capture system was used to detect joint angle .

  6. Motion distance

    Time frame: 4 weeks

    Three-dimensional motion capture system was used to detect motion distance.

  7. Fugl-Meyer Assessment Upper Extremity Scale(FMA-UE)

    Time frame: 4 weeks

    FMA-UE is a commonly used scale for assessing upper limb motor function in stroke patients, mainly evaluating reflex activity, motor control, and muscle strength of the hemiplegic upper limb. FMA-UE includes 33 items related to proximal and distal limb movements of the upper limbs, with each item scored on a scale of 0, 1, and 2. 0 points indicates complete inability to complete, 2 points indicates ability to complete the specified action, and 1 point falls between the two; The total score ranges from 0 to 66 points. The higher the score, the better the upper limb function.

  8. Modified Ashworth Scale(MAS)

    Time frame: 4 weeks

    MAS is a standardized tool for assessing the degree of muscle spasms and has been established as the clinical gold standard in the assessment of limb spasms after stroke. This scale is divided into levels 0-4, with higher levels indicating greater muscle tone.

  9. Mean Frequency (MF)of SEMG

    Time frame: 4 weeks

    Using sEMG, the EMG signals of the upper limb muscles are collected, including MF.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

Three-dimensional Motion Capture System Combined With sEMG Was Used to Evaluate the Effect of Different Firebone Acupuncture Strategies on Upper Limb Function in Stroke Patients

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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