Fu's Subcutaneous Needling Treatment for Hemiplegic Shoulder Pain

NCT ID: NCT05085236

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-26
• Study Completion Date: 2024-09-06

Brief Summary

The post-stroke survivors suffered from shoulder pain are very common. The investigators performed Fu's subcutaneous needling (FSN). This experiment used a randomized controlled trial to assess the immediate, short-term and long-term effects of Fu's subcutaneous needling therapy on hemiplegic shoulder pain in patient with stroke.

Detailed Description

The prevalence of complication in post-stroke survivors is 30-96%. Post-stroke pain is the most common complication. According to previous researches there are sixty percent post-stroke survivors who suffered from upper limb pain. The mechanism causes post-stroke shoulder pain is imbalance of shoulder muscles and in-coordination of shoulder motor control due to cerebral vascular disease. Post-stroke shoulder pain often causes the limitation of shoulder range of motion, and the pain always affected quality of life and daily activities. Because of shoulder pain, those post-stroke survivors postponed the program of rehabilitation. The treatments of post-stroke shoulder pain are transcutaneous electrical nerve stimulation, drug, intra-articular injection and nerve block. Acupuncture with combination of rehabilitation has been proved by many researches in alleviating pain and increasing quality of life in treating post-stroke shoulder pain. Fu's subcutaneous needling is a newly technique based on meridian theory and the technique is used to treat cervical, lumbar and four limb's pain proved by many researches. Fu's subcutaneous needling in managing post-stroke pain has less reported, so investigator set up a proposal to see if the Fu's subcutaneous needling could elevate more therapeutic effect compared to usual care or not.

The investigators will enroll patients into two groups, experimental and control groups. The interventions in experimental group are Fu's subcutaneous needling in combination with rehabilitation, and in control group is rehabilitation. The trial will extend two weeks, and investigator will treat with Fu's subcutaneous needling three times in the first, second and fourth day when the patients include to our trial. The outcome measurements are visual analog scale, range of motion of shoulder, pressure pain threshold of myofascial trigger point, acromion-greater tuberosity distance, Fugl-Meyer assessment in upper extremity and functional independence measure.

Conditions

Hemiplegic Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fu's subcutaneous needling (FSN) in combination with rehabilitation

In this arm, the subjects will receive the intervention of FSN combined with regular rehabilitation program on Day1, Day2, and Day4, in total 3 treatments. The subjects will receive assessments before and after each interventions. After total treatments finishing, the subjects will receive assessments on Day8 and Day15.

Group Type: EXPERIMENTAL

Fu's subcutaneous needling (FSN)

Intervention Type: PROCEDURE

physician will use a disposable Fu's subcutaneous needling (FSN) to penetrate the subject's skin in the middle from elbow lateral epicondyle to radial styloid process. Then physician will push forward the needle parallel to the skin surface. the physician will sway the needle 100 times in a minute. After procedure of swaying needle, the physician will instruct subject to do several movements, and each movement will perform 10 seconds and rest 10 seconds for 3 repetitions. The movements are active isometric elbow flexion, active isometric shoulder internal rotation, passive shoulder external and internal rotation. After above re-perfusion approach of muscles, the physician will take out the needle to finish the treatment.

Rehabilitation

Intervention Type: PROCEDURE

Rehabilitation mentioned here is the regular rehabilitation programs for treating post-stroke hemiplegic shoulder pain prescribed by the rehabilitation physician.

Rehabilitation

In this arm, the subjects will receive the intervention of regular rehabilitation program prescribed by physician of rehabilitation. On Day1, Day2, and Day4, the subjects will receive assessments before and after each interventions. After total treatments finishing, the subjects will receive assessments on Day8 and Day15.

Group Type: ACTIVE_COMPARATOR

Rehabilitation

Intervention Type: PROCEDURE

Rehabilitation mentioned here is the regular rehabilitation programs for treating post-stroke hemiplegic shoulder pain prescribed by the rehabilitation physician.

Interventions

Fu's subcutaneous needling (FSN)

physician will use a disposable Fu's subcutaneous needling (FSN) to penetrate the subject's skin in the middle from elbow lateral epicondyle to radial styloid process. Then physician will push forward the needle parallel to the skin surface. the physician will sway the needle 100 times in a minute. After procedure of swaying needle, the physician will instruct subject to do several movements, and each movement will perform 10 seconds and rest 10 seconds for 3 repetitions. The movements are active isometric elbow flexion, active isometric shoulder internal rotation, passive shoulder external and internal rotation. After above re-perfusion approach of muscles, the physician will take out the needle to finish the treatment.

Intervention Type: PROCEDURE

Rehabilitation

Rehabilitation mentioned here is the regular rehabilitation programs for treating post-stroke hemiplegic shoulder pain prescribed by the rehabilitation physician.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 1. Volunteers who are older than 40 years old suffered from first stroke attack including infarction and hemorrhage with image proved and can cooperate with the experiment.
• 2. Stroke patient suffered from shoulder pain.
• 3. Patient can follow the directions of Fu's subcutaneous needling and regular rehabilitation program.

Exclusion Criteria

• 1. There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant and lactated women.
• 2. There has been a history of drug abuse (including excess alcohol) that affects pain assessment.
• 3. Cognitive impairment, unable to cooperate with the experiment.
• 4. Aphasia
• 5. Have received shoulder joint injection in recent 6 months.
• 6. Have serious skin infection, laceration, wound and trauma.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li-Wei Chou, PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CMUH110-REC2-124

Identifier Type: -

Identifier Source: org_study_id