Clinical trial NCT05395325: 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
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Hemiplegic Shoulder Pain
Keywords: hemiplegic shoulder pain
Kinesiotaping
Stroke
steroid injection
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the change from baseline to time of Fugl-Meyer assessment for upper extremity
timeFrame: 4th week, and 7th week
measure: the change from baseline to time of Flexilevel Scale of Shoulder Function
timeFrame: 4th week, and 7th week
Secondary outcomes:
measure: the change from baseline to time of Brunnstrom stage
timeFrame: 4th week, and 7th week
measure: the change from baseline to time of quality of life by Stroke Impact Scale
timeFrame: 4th week, and 7th week
measure: the change from baseline to time of quality of life by Barthel Index
timeFrame: 4th week, and 7th week
measure: the change from baseline to time of functional performance by box and block test
timeFrame: 4th week, and 7th week
measure: the change from baseline to time of functional performance by STEF
timeFrame: 4th week, and 7th week
measure: the change from baseline to time of VAS
timeFrame: 4th week, and 7th week
measure: the change from baseline to time of PROM
timeFrame: 4th week, and 7th week
measure: the change from baseline to time of edema
timeFrame: 4th week, and 7th week
measure: the change from baseline to time of MAS scale
timeFrame: 4th week, and 7th week
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yuchi Huang
role: STUDY_CHAIR
References: