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

NCT07140406 | Active Not Recruiting

• 1 other identifier: KYLL-202309-045-2
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Infarction

Keywords

dysfunction; stroke; fire needle; Surface electromyography; 3D motion capture system

Outcome Measures

Primary Outcomes (1)

• Root mean square(RMS) of surface electromyography(sEMG）

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

  4 weeks

Secondary Outcomes (9)

• RMS of sEMG

  first day

• Mean Frequency (MF)of SEMG

  first day

• Joint angle

  first day

• Motion distance

  first day

• Joint angle

  4 weeks

Study Arms (3)

Flexed muscle Milli-fire needle

EXPERIMENTAL

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.

Other: conventional rehabilitation training; Other: conventional acupuncture; Other: Acupuncture with the milli-needle fire-puncture on flexor muscle groups

Extensor muscle Milli-fire needle

EXPERIMENTAL

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.

Other: conventional rehabilitation training; Other: conventional acupuncture; Other: Acupuncture with the milli-needle fire-puncture on extensor muscle groups

Control group

ACTIVE COMPARATOR

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.

Other: conventional rehabilitation training; Other: conventional acupuncture; Other: Conventional needle puncture with a fire needle

Interventions

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.

Control group; Extensor muscle Milli-fire needle; Flexed muscle Milli-fire needle

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.

Control group; Extensor muscle Milli-fire needle; Flexed muscle Milli-fire needle

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.

Flexed muscle Milli-fire needle

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.

Extensor muscle Milli-fire needle

Conventional needle puncture with a fire needle OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Cerebral Infarction; Stroke

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acupuncture and moxibustion therapist

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 24, 2025
• Study Start: December 2, 2023
• Primary Completion: September 30, 2025
• Study Completion: October 31, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)