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

NCT ID: NCT05395325

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-05
• Study Completion Date: 2024-08-31

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.

Conditions

Stroke; Hemiplegic Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KT and steroid injection group

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.

Group Type: EXPERIMENTAL

Kinesiotaping

Intervention Type: 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.

Hand rehabilitation program

Intervention Type: 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

Steroid injection

Intervention Type: 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 group

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.

Group Type: SHAM_COMPARATOR

Kinesiotaping

Intervention Type: 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.

Hand rehabilitation program

Intervention Type: 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

Interventions

Kinesiotaping

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

Hand rehabilitation program

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

Steroid injection

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuchi Huang

Role: STUDY_CHAIR

Chang Gung Memorial Hospital

Locations

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yuchi Huang, MD

Role: CONTACT

hyuchi@gmail.com

+866-7-7317123 ext. 6286

Facility Contacts

Yuchi Huang, MD

Role: primary

hyuchi@gmail.com

+886-7-7317123

Other Identifiers

CMRPG8M0431

Identifier Type: -

Identifier Source: org_study_id