The Effectiveness of High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain: A Prospective Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Pain of the hemiplegic shoulder
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Yasin Demir
Physical Medicine and Rehabilitation Specialist
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital