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

NCT05395325 | Recruiting

• 1 other identifier: CMRPG8M0431
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiplegic Shoulder Pain

Keywords

hemiplegic shoulder pain; Kinesiotaping; Stroke; steroid injection

Outcome Measures

Primary Outcomes (2)

• 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.

  4th week, and 7th week

• 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.

  4th week, and 7th week

Secondary Outcomes (9)

• the change from baseline to time of Brunnstrom stage

  4th week, and 7th week

• the change from baseline to time of quality of life by Stroke Impact Scale

  4th week, and 7th week

• the change from baseline to time of quality of life by Barthel Index

  4th week, and 7th week

• the change from baseline to time of functional performance by box and block test

  4th week, and 7th week

• the change from baseline to time of functional performance by STEF

  4th week, and 7th week

Study Arms (2)

KT and steroid injection group

EXPERIMENTAL

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.

Other: Kinesiotaping; Other: Hand rehabilitation program; Other: Steroid injection

KT group

SHAM COMPARATOR

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.

Other: Kinesiotaping; Other: Hand rehabilitation program

Interventions

Kinesiotaping OTHER

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.

KT and steroid injection group; KT group

Hand rehabilitation program OTHER

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

KT and steroid injection group; KT group

Steroid injection OTHER

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.

KT and steroid injection group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Steroids

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Yuchi Huang

  Chang Gung Memorial Hospital

  STUDY CHAIR

Central Study Contacts

Yuchi Huang, MD

CONTACT

+866-7-7317123; hyuchi@gmail.com

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: May 24, 2022
• First Posted: May 27, 2022
• Study Start: May 5, 2022
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)