High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain
- Conditions
- Hemiplegia
- Interventions
- Device: High intensity laser therapyOther: Therapeutic Exercise
- Registration Number
- NCT04669405
- Lead Sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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
- Arm && Interventions
Group Intervention Description HILT group Therapeutic Exercise Patients with hemiplegic shoulder pain with partial thickness rotator cuff receiving high intensity laser therapy. HILT group High intensity laser therapy Patients with hemiplegic shoulder pain with partial thickness rotator cuff receiving high intensity laser therapy. Control group Therapeutic Exercise Patients with hemiplegic shoulder pain with partial thickness rotator cuff receiving exercise.
- Primary Outcome Measures
Name Time Method Pain of the hemiplegic shoulder 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 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.
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 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
Motor recovery Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm motor recovery of the patients at 3 weeks Brunnstrom Recovery Stage (BRS) was used to appreciated the motor function level in the patients. The recovery are divided into six stages: In the 1st stage, there is complete flaccidity, and no voluntary movements in the involved body area, while the 6th stage indicates normal function
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.
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
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 Ultrasonographycally detected a hypoechoic / anechoic focus in the cuff material or a hypoechoic / anechoic defect in the tendon that holds the bursal or articular surface
Trial Locations
- Locations (1)
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
🇹🇷Ankara, Turkey