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Fu's Subcutaneous Needling Treatment for Hemiplegic Shoulder Pain

Primary Purpose

Hemiplegic Shoulder Pain

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Fu's subcutaneous needling (FSN)
Rehabilitation
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegic Shoulder Pain focused on measuring Fu's subcutaneous needling, post-stroke complications, post-stroke shoulder pain, hemiplegic shoulder pain, shoulder hand syndrome

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Rehabilitation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 7, 2021
Last Updated
December 7, 2022
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05085236
Brief Title
Fu's Subcutaneous Needling Treatment for Hemiplegic Shoulder Pain
Official Title
Therapeutic Effect of Fu's Subcutaneous Needling for Recovery Outcomes of Stroke Survivors With Hemiplegic Shoulder Pain.: Randomized-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 26, 2021 (Actual)
Primary Completion Date
August 26, 2023 (Anticipated)
Study Completion Date
August 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Shoulder Pain
Keywords
Fu's subcutaneous needling, post-stroke complications, post-stroke shoulder pain, hemiplegic shoulder pain, shoulder hand syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fu's subcutaneous needling (FSN) in combination with rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fu's subcutaneous needling (FSN)
Intervention Description
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
Intervention Name(s)
Rehabilitation
Intervention Description
Rehabilitation mentioned here is the regular rehabilitation programs for treating post-stroke hemiplegic shoulder pain prescribed by the rehabilitation physician.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
1 day
Title
Pressure Pain Threshold
Description
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
Time Frame
1 day
Title
Range of Motion of Shoulder
Description
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.
Time Frame
1 day
Title
Acromion-GreaterTuberosity Distance
Description
In this study we assess of shoulder joint subluxation by means of ultrasound measurement of Acromion-greater tuberosity distance.
Time Frame
1 day
Title
Fugl-Meyer assessment in upper extremity
Description
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.
Time Frame
1 day
Title
Functional Independence Measure
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Wei Chou, PhD
Phone
+886-4-22052121
Ext
2381
Email
chouliwe@mail.cmuh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Wei Chou, PhD
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
999079
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chou Li-Wei, PhD
Phone
+886-4-22052121
Ext
2381
Email
chouliwe@mail.cmuh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Fu's Subcutaneous Needling Treatment for Hemiplegic Shoulder Pain

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