Fu's Subcutaneous Needling Treatment for Hemiplegic Shoulder Pain

NCT05085236 | Completed

• 1 other identifier: CMUH110-REC2-124
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegic Shoulder Pain

Keywords

Fu's subcutaneous needling; post-stroke complications; post-stroke shoulder pain; hemiplegic shoulder pain; shoulder hand syndrome

Outcome Measures

Primary Outcomes (6)

• Visual Analog Scale

  A Visual Analog Scale consists of a line, often 10 cm long, with verbal anchors at either end, on left of line, zero, meant no pain otherwise on right, 10, meant strong pain. The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.

  1 day

• Pressure Pain Threshold

  Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom

  1 day

• Range of Motion of Shoulder

  Range of Motion is the measurement of movement around a specific joint, measured in degrees of a circle. In this study we measure shoulder joint, glenohumeral joint, in flexion, extension, external and internal rotation.

  1 day

• Acromion-GreaterTuberosity Distance

  In this study we assess of shoulder joint subluxation by means of ultrasound measurement of Acromion-greater tuberosity distance.

  1 day

• Fugl-Meyer assessment in upper extremity

  The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. In upper extremity, we measure motor function included shoulder, elbow, wrist and hand, and assess coordination using finger to nose.

  1 day

• Functional Independence Measure

  The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability. Includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition.

  1 day

Study Arms (2)

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

EXPERIMENTAL

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.

Procedure: Fu's subcutaneous needling (FSN); Procedure: Rehabilitation

Rehabilitation

ACTIVE COMPARATOR

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.

Procedure: Rehabilitation

Interventions

Fu's subcutaneous needling (FSN) 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.

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

Rehabilitation PROCEDURE

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

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Stroke patient suffered from shoulder pain.
• \. Patient can follow the directions of Fu's subcutaneous needling and regular rehabilitation program.

You may not qualify if:

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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 999079, Taiwan

Location

MeSH Terms

Conditions

Reflex Sympathetic Dystrophy

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Complex Regional Pain Syndromes; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Li-Wei Chou, PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: November 26, 2021
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: April 24, 2025

Record last verified: 2024-08

Locations

TW (1)