Clinical Effects of Combined Kinesiotaping and Steroid Injection in Stroke Patients With Hemiplegic Shoulder Pain

Not Applicable

Recruiting

• Conditions: Stroke; Hemiplegic Shoulder Pain
• Interventions: Other: Kinesiotaping; Other: Hand rehabilitation program; Other: Steroid injection

• Registration Number: NCT05395325
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2022-05-05
• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-07-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KT and steroid injection group	Hand rehabilitation program	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.
KT and steroid injection group	Kinesiotaping	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.
KT group	Kinesiotaping	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.
KT and steroid injection group	Steroid injection	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.
KT group	Hand rehabilitation program	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.

Primary Outcome Measures

Name	Time	Method
the change from baseline to time of Flexilevel Scale of Shoulder Function	4th week, and 7th week	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.
the change from baseline to time of Fugl-Meyer assessment for upper extremity	4th week, and 7th week	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.

Secondary Outcome Measures

Name	Time	Method
the change from baseline to time of quality of life by Stroke Impact Scale	4th week, and 7th week	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 VAS	4th week, and 7th week	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 quality of life by Barthel Index	4th week, and 7th week	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 STEF	4th week, and 7th week	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 PROM	4th week, and 7th week	a therapist will measure passive range of motions of shoulder joint.
the change from baseline to time of MAS scale	4th week, and 7th week	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.
the change from baseline to time of Brunnstrom stage	4th week, and 7th week	a therapist will measure motor recovery stage (Brunnstrom stage)
the change from baseline to time of functional performance by box and block test	4th week, and 7th week	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 edema	4th week, and 7th week	a therapist will measure forearm, wrist and middle palm circumference to assess edema.

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan