Clinical Effects of Combined Kinesiotaping and Steroid Injection in Stroke Patients With Hemiplegic Shoulder Pain
Primary Purpose
Stroke, Hemiplegic Shoulder Pain
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Kinesiotaping
Hand rehabilitation program
Steroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring hemiplegic shoulder pain, Kinesiotaping, Stroke, steroid injection
Eligibility Criteria
Inclusion Criteria:
- The patients have a stroke with hemiplegia (duration is less than 6 months after stroke).
- The patients complain about shoulder pain and there're soft tissue impairment under sonography measurement.
- Patients who are able to perform slightly hand grasp( at least 10 degrees at metacarpophalangeal and interphalangeal joints).
Exclusion Criteria:
- age is younger than 20 years old or older than 80 years old
- previous history of upper extremity tendon or neuromuscular injury, shoulder pain, frozen shoulder or shoulder surgery before stroke,
- any other systemic neuromuscular disease; cognition or language impairment leading to communication difficulty.
- allergic to kinesio tape
Sites / Locations
- Kaohsiung Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
KT and steroid injection group
KT group
Arm Description
the patients will receive steroid injection for only one time before intervention, and receive KT for 5 days a week, for three weeks. And a 30-minute hand functional training would also be provided once daily every day during the intervention.
the patients will receive KT for 5 days a week, for three weeks. And a 30-minute hand functional training would also be provided once daily every day during the intervention.
Outcomes
Primary Outcome Measures
the change from baseline to time of Fugl-Meyer assessment for upper extremity
a therapist will evaluate Fugl-Meyer assessment for upper extremity (FMA-UE) for each participant. In this assessment, participants would need to execute a series of movements, which involved proximal and distal part of upper limb. The higher the grade, the better the performance. The total score ranges from 0 to 66 for motor function.
the change from baseline to time of Flexilevel Scale of Shoulder Function
Flexilevel Scale of Shoulder Function(FLEX-SF) would be used to measure the shoulder performance in daily activities.It is a self-reported questionnaire. The higher the grade, the better the performance.
Secondary Outcome Measures
the change from baseline to time of Brunnstrom stage
a therapist will measure motor recovery stage (Brunnstrom stage)
the change from baseline to time of quality of life by Stroke Impact Scale
Stroke Impact Scale would be used to measure the independence of daily activities. It is a self-reported questionnaire. The contents involve various aspect of life. The high the grade, the more serious the life is affected. The total score is from 0 to 100 for self-assessing the level of recovery.
the change from baseline to time of quality of life by Barthel Index
Barthel Index would be used to measure the independence of daily activities. It is a form that contains different activities of daily living. The higher the outcome grades, the better the level of independence.
the change from baseline to time of functional performance by box and block test
box and block test would be used to assess the grasping and release performance of the affected hand.
the change from baseline to time of functional performance by STEF
Simple Test for Evaluating Hand Function (STEF) would be used to assess the hand function by executing various types of grasping.
the change from baseline to time of VAS
Visual Analog Scale (VAS) would be used to assess the self-reported shoulder pain level of patients. The score ranges from 0 to 10. The higher the grades, the worst pain the patients experienced.
the change from baseline to time of PROM
a therapist will measure passive range of motions of shoulder joint.
the change from baseline to time of edema
a therapist will measure forearm, wrist and middle palm circumference to assess edema.
the change from baseline to time of MAS scale
a therapist will measure spasticity of affected upper extremity at elbow and wrist joints (modified Ashworth scale). In this scale, muscle tone would be assessed by quick stretch of muscle belly. The scoring criteria are as follows. 0, no increase in muscle tone; 1, Slight increase in muscle tone; 2, More marked increase in muscle tone through most of the ROM; 3, considerable increase in muscle tone; 4, affected part(s) rigid in flexion or extension.
Full Information
NCT ID
NCT05395325
First Posted
May 24, 2022
Last Updated
May 30, 2022
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05395325
Brief Title
Clinical Effects of Combined Kinesiotaping and Steroid Injection in Stroke Patients With Hemiplegic Shoulder Pain
Official Title
The Clinical Effects of Combined Kinesiotaping and Steroid Injection in Stroke Patients With Hemiplegic Shoulder Pain : A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial 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 aims of this study is to investigate sono-guided shoulder steroid injection combined with Kinesiotaping applications in reducing shoulder pain, improving functional performance on upper extremity and quality of life in stroke patients with hemiplegic shoulder pain.
Detailed Description
Hemiplegic shoulder pain is one of the most common complications in stroke patients, and it has negative effects on rehabilitation in hemiplegic side, functional recovery of upper extremity, and quality of life. The common treatments for hemiplegic shoulder pain include oral medication,transcutaneous electrical nerve stimulation, and local injections. Steroid or sodium hyaluronate are mainly used in local injections. Steroid can suppress inflammation and immune system effectively.
Furthermore, the clinical characteristics of impaired motor performance on affected limb in stroke patients include muscle weakness, increased muscle tone, contracture, joint instability, or impaired of motor control. Impaired motor performance of upper extremity and spasticity have negative impacts in functional performances and daily activities. In stroke patients with poststroke spasticity, stretching, range of motion exercises, antispasticity splint, neuromuscular electrical stimulation, oral medications and local injection of botulinum toxin are recommended. Some investigators found that Kinesiotaping (KT) combined with other interventions may facilitate muscle function, provide joint support and proprioception feedback, and reduce pain in stroke patients with hemiplegia. Thus, the investigators will perform steroid injection in stroke patients with hemiplegic shoulder pain to reduce pain, and apply KT while receiving rehabilitation to facilitate motor recovery and functional performance in affected upper extremity.
In this study, 50 stroke patients with hemiplegic shoulder pain will be recruited and randomly divided into experimental and control groups. In experimental group(n=25), the patients will receive KT combined steroid injection with rehabilitation, and the injection will perform only one time in the entire intervention period. In control group, the patients will receive KT with rehabilitation. In both groups, KT will be applied for three weeks. All participants will receive shoulder sonography evaluation before intervention to investigate the condition of hemiplegic shoulder pain and receive physical examination, hand function assessment before intervention, after the three-week intervention and three-week post intervention.
The aims of this study is to investigate sono-guided shoulder steroid injection combined with Kinesiotaping applications in reducing shoulder pain, improving functional performance on upper extremity and quality of life in stroke patients with hemiplegic shoulder pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegic Shoulder Pain
Keywords
hemiplegic shoulder pain, Kinesiotaping, Stroke, steroid injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KT and steroid injection group
Arm Type
Experimental
Arm Description
the patients will receive steroid injection for only one time before intervention, and receive KT for 5 days a week, for three weeks. And a 30-minute hand functional training would also be provided once daily every day during the intervention.
Arm Title
KT group
Arm Type
Sham Comparator
Arm Description
the patients will receive KT for 5 days a week, for three weeks. And a 30-minute hand functional training would also be provided once daily every day during the intervention.
Intervention Type
Other
Intervention Name(s)
Kinesiotaping
Intervention Description
Kinesio tape would be applied (1)over the extensor muscles of the affected hand for facilitating the extension of hand. We will apply the tape from the upper 1/3 length of dorsal side of the forearm and split the tape into five equal bars to the distal interphalangeal joint of each finger along the finger bones. (2) from above the scapula spine to the medial deltoid. (3) from medial border of scapula to anterior deltoid.This intervention would be executed for five days per week for three weeks.
Intervention Type
Other
Intervention Name(s)
Hand rehabilitation program
Intervention Description
In the thirty-minute hand rehabilitation program, a motor-relearning theory would be implemented into the intervention by teaching the participants how to use their upper limb properly without any compensatory motions. Therefore, for establishing a correct movement pattern, an occupational therapist would provide a hand-guided activity, in which the participants could practice reaching movement as well as hand grasp and release in a more natural way. Besides, the therapist would also help the patients release their muscle tone by stretching the spastic muscles for five minutes before and after this hand rehabilitation period
Intervention Type
Other
Intervention Name(s)
Steroid injection
Intervention Description
all the steroid injection would be executed by physicians. The 23G needles would be used for the injections. The examiners would be clear and familiar with the protocol, and the injections would be executed for only one time during the study period in experimental group.
Primary Outcome Measure Information:
Title
the change from baseline to time of Fugl-Meyer assessment for upper extremity
Description
a therapist will evaluate Fugl-Meyer assessment for upper extremity (FMA-UE) for each participant. In this assessment, participants would need to execute a series of movements, which involved proximal and distal part of upper limb. The higher the grade, the better the performance. The total score ranges from 0 to 66 for motor function.
Time Frame
4th week, and 7th week
Title
the change from baseline to time of Flexilevel Scale of Shoulder Function
Description
Flexilevel Scale of Shoulder Function(FLEX-SF) would be used to measure the shoulder performance in daily activities.It is a self-reported questionnaire. The higher the grade, the better the performance.
Time Frame
4th week, and 7th week
Secondary Outcome Measure Information:
Title
the change from baseline to time of Brunnstrom stage
Description
a therapist will measure motor recovery stage (Brunnstrom stage)
Time Frame
4th week, and 7th week
Title
the change from baseline to time of quality of life by Stroke Impact Scale
Description
Stroke Impact Scale would be used to measure the independence of daily activities. It is a self-reported questionnaire. The contents involve various aspect of life. The high the grade, the more serious the life is affected. The total score is from 0 to 100 for self-assessing the level of recovery.
Time Frame
4th week, and 7th week
Title
the change from baseline to time of quality of life by Barthel Index
Description
Barthel Index would be used to measure the independence of daily activities. It is a form that contains different activities of daily living. The higher the outcome grades, the better the level of independence.
Time Frame
4th week, and 7th week
Title
the change from baseline to time of functional performance by box and block test
Description
box and block test would be used to assess the grasping and release performance of the affected hand.
Time Frame
4th week, and 7th week
Title
the change from baseline to time of functional performance by STEF
Description
Simple Test for Evaluating Hand Function (STEF) would be used to assess the hand function by executing various types of grasping.
Time Frame
4th week, and 7th week
Title
the change from baseline to time of VAS
Description
Visual Analog Scale (VAS) would be used to assess the self-reported shoulder pain level of patients. The score ranges from 0 to 10. The higher the grades, the worst pain the patients experienced.
Time Frame
4th week, and 7th week
Title
the change from baseline to time of PROM
Description
a therapist will measure passive range of motions of shoulder joint.
Time Frame
4th week, and 7th week
Title
the change from baseline to time of edema
Description
a therapist will measure forearm, wrist and middle palm circumference to assess edema.
Time Frame
4th week, and 7th week
Title
the change from baseline to time of MAS scale
Description
a therapist will measure spasticity of affected upper extremity at elbow and wrist joints (modified Ashworth scale). In this scale, muscle tone would be assessed by quick stretch of muscle belly. The scoring criteria are as follows. 0, no increase in muscle tone; 1, Slight increase in muscle tone; 2, More marked increase in muscle tone through most of the ROM; 3, considerable increase in muscle tone; 4, affected part(s) rigid in flexion or extension.
Time Frame
4th week, and 7th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients have a stroke with hemiplegia (duration is less than 6 months after stroke).
The patients complain about shoulder pain and there're soft tissue impairment under sonography measurement.
Patients who are able to perform slightly hand grasp( at least 10 degrees at metacarpophalangeal and interphalangeal joints).
Exclusion Criteria:
age is younger than 20 years old or older than 80 years old
previous history of upper extremity tendon or neuromuscular injury, shoulder pain, frozen shoulder or shoulder surgery before stroke,
any other systemic neuromuscular disease; cognition or language impairment leading to communication difficulty.
allergic to kinesio tape
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuchi Huang, MD
Phone
+866-7-7317123
Ext
6286
Email
hyuchi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuchi Huang
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuchi Huang, MD
Phone
+886-7-7317123
Email
hyuchi@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Effects of Combined Kinesiotaping and Steroid Injection in Stroke Patients With Hemiplegic Shoulder Pain
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