High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain

Not Applicable

Recruiting

• Conditions: Hemiplegia; Musculoskeletal Diseases; Shoulder Pain; Arthralgia; Joint Diseases

• Registration Number: NCT05564182
• Lead Sponsor: Afyonkarahisar Health Sciences University

Brief Summary

High intensity laser therapy (HILT) has been considered as a treatment option for shoulder pain. In randomized controlled studies with high-intensity laser therapy (HILT), there are publications showing its effectiveness in conditions such as shoulder pathologies such as subacromial impigment syndrome and adhesive capsulitis. However, there are few studies in the literature that focus on the effectiveness of HILT, especially in hemiplegic shoulder pain. In this study, we intended to investigate the effectiveness of HILT on pain, disability, function and quality of life in patients with HSP accompanied by PTRCT.

Detailed Description

The study was designed as prospective, randomized, controlled trial. Patients with HSP accompanied by PTRCT (n=40) were randomly assigned to HILT and control groups. Group 1 (HILT group, n=20) received 3 sessions of HILT per week for 3 weeks in addition to the exercise program which performed 5 sessions per week for 3 weeks. Group 2 (Control group, n=20) received an exercise program for HSP of 5 sessions per week for 3 weeks.

Participants were evaluated with Visual Analog Scale (VAS), passive Range of Motion (ROM), Shoulder Pain and Disability Index (SPADI), Nottingham Health Profile (NHP), Functional Independence Measure (FIM) and ultrasonographic PTRCT size,Fugl Meyer Assessment, Brunnstrom Stages, Modified Ashworth Scale (MAS) Nottingham Health Profile (NHP).

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-10
• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-09-29
• Last Update Submitted: 2022-09-29
• Study First Posted: 2022-10-03
• Last Update Posted: 2022-10-03
• Primary Completion: 2022-12-10
• Study Completion: 2023-02-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with HSP aged 50-85 years with hemiplegia duration> 2 months, suffered a stroke resulting in unilateral hemiplegia for the first time

Exclusion Criteria

• Cases who had inflammatory rheumatic disease, cervical radiculopathy, diabetes mellitus, thyroid disease, coronary heart disease, cardiac pace-maker, neurological disease, shoulder surgery, and shoulder injection in the last 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder pain of the patients at 3 weeks	Severity of pain was assessed using the standart 10 cm VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end

Secondary Outcome Measures

Name	Time	Method
Range of motion (ROM) of the hemiplegic shoulder	Time Frame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder ROM of the patients at 3 weeks	Passive ROM measurements of shoulder external rotation, abduction, and flexion movements were recorded by a universal goniometer.
Fugl Meyer Assessment (upper extremity)	Through study completion, an average of 3 weeks (Change from baseline quality of life of the patients at 3 weeks	The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.The FM scale is divided into 5 areas: motor function, sensory function, balance, range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ranking scale (0 = unable to perform, 1 = partially performs, 2 = fully performs).Higher scores is better.
Shoulder Pain and Disability Index (SPADI)	Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm motor recovery of the patients at 3 weeks	The SPADI is a joint-specific measure focusing on pain and functional activities involving the shoulder.SPADI is self-administered questionnaire composed of 5 items assessing pain and 8 items assessing disability. The score varied from 0% to 100%, with higher scores reflected greater pain and disability
Spastisity	Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm spasticity of the patients at 3 weeks	The five-point Modified Ashworth Scale (MAS), a clinical scale ranging from 0 to 4 (0 being normal muscle tone, and 4 being rigid) was used for measuring spasticity and muscle tone. Higher scores indicate severe spasticity.
Functional status (FIM)	Through study completion, an average of 3 weeks (Change from baseline functional status of the patients at 3 weeks	FIM is a universal assessment tool consisting of a total of 18 items that explores an individual's several physical and social functions, such as self-care, transfer, locomotion, sphincter control, communication and social cognition. Each item is scored on a 7-point ordinal scale ranging from complete independence (score= 7) to complete dependence (score= 1). Higher FIM scores indicate higher levels of independence
Quality of life of the hemiplegic patient	Through study completion, an average of 3 weeks (Change from baseline quality of life of the patients at 3 weeks	Nottingham Health Profile (NHP), a life quality test, includes 38 yes / no statements regarding pain, physical mobility, emotional reactions, sleep, social isolation and energy level. Ratings on each component are weighted to give a score between 0 and 100. Higher NHP scores show a higher level of trouble

Trial Locations

Locations (1)

Afyonkarahisar Health Sciences University; 🇹🇷 Afyonkarahisar, Turkey