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Clinical Trials/NCT04669405
NCT04669405
Completed
Not Applicable

The Effectiveness of High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain: A Prospective Randomized Controlled Study

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital1 site in 1 country44 target enrollmentApril 1, 2019
ConditionsHemiplegia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemiplegia
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Enrollment
44
Locations
1
Primary Endpoint
Pain of the hemiplegic shoulder
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

High intensity laser therapy (HILT) has been considered as a treatment option for shoulder pain. To our knowledge, the effectiveness of HILT in patients with hemiplegic shoulder pain (HSP) with partial thickness rotator cuff tear (PTRCT) is unknown. 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=44) were randomly assigned to HILT and control groups. Group 1 (HILT group, n=22) 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=22) 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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
September 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yasin Demir

Physical Medicine and Rehabilitation Specialist

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with HSP (at least 4/10 points from VAS) aged 18-75 years with hemiplegia duration\> 6 months, suffered a stroke resulting in unilateral hemiplegia for the first time, and who had partial thickness RCT after ultrasonographic evaluation due to shoulder pain

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

Outcomes

Primary Outcomes

Pain of the hemiplegic shoulder

Time Frame: 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 Outcomes

  • Range of motion (ROM) of the hemiplegic shoulder(Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder ROM of the patients at 3 weeks)
  • Shoulder functional status (SPADI)(Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder functional status of the patients at 3 weeks)
  • Motor recovery(Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm motor recovery of the patients at 3 weeks)
  • Spastisity(Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm spasticity of the patients at 3 weeks)
  • Functional status (FIM)(Through study completion, an average of 3 weeks (Change from baseline functional status of the patients at 3 weeks)
  • 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)
  • Rotator cuff tear size(Through study completion, an average of 3 weeks (Change from baseline rotator tear cuff size of the patients at 3 weeks)

Study Sites (1)

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