Clinical trial NCT05564182: High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain
Official title: Efficacy of High Intensity Laser Treatment in Hemiplegic Shoulder Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Hemiplegia
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Keywords: hemiplehic shoulder pain
rotator cuff tear
high intensity laser therapy
exercise
ultrasound
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder pain of the patients at 3 weeks
Secondary outcomes:
measure: Range of motion (ROM) of the hemiplegic shoulder
timeFrame: Time Frame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder ROM of the patients at 3 weeks
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm motor recovery of the patients at 3 weeks
measure: Spastisity
timeFrame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm spasticity of the patients at 3 weeks
measure: Functional status (FIM)
timeFrame: Through study completion, an average of 3 weeks (Change from baseline functional status of the patients at 3 weeks
measure: Quality of life of the hemiplegic patient
timeFrame: Through study completion, an average of 3 weeks (Change from baseline quality of life of the patients at 3 weeks
measure: Fugl Meyer Assessment (upper extremity)
timeFrame: Through study completion, an average of 3 weeks (Change from baseline quality of life of the patients at 3 weeks
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Sciences University
Study officials:
References:
citation: Viana R, Pereira S, Mehta S, Miller T, Teasell R. Evidence for therapeutic interventions for hemiplegic shoulder pain during the chronic stage of stroke: a review. Top Stroke Rehabil. 2012 Nov-Dec;19(6):514-22. doi: 10.1310/tsr1906-514.
citation: Tao W, Fu Y, Hai-Xin S, Yan D, Jian-Hua L. The application of sonography in shoulder pain evaluation and injection treatment after stroke: a systematic review. J Phys Ther Sci. 2015 Sep;27(9):3007-10. doi: 10.1589/jpts.27.3007. Epub 2015 Sep 30.
citation: Song HJ, Seo HJ, Lee Y, Kim SK. Effectiveness of high-intensity laser therapy in the treatment of musculoskeletal disorders: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Dec;97(51):e13126. doi: 10.1097/MD.0000000000013126.