High-intensity Laser Therapy (HILT) or Conventional Combined Physical Therapy in the Management of Hemiplegic Shoulder Pain ; Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- arm motor ability test
Study Overview
Brief Summary
Background: Hemiplegic shoulder pain is one of the most common complications after a stroke. There are many treatment strategies for this complication. High-intensity laser therapy (HILT) is a new treatment option, and we aimed to compare the effectiveness of conventional electrotherapy agents and HILT in this study.
Patients and methods: Participants (N = 42) were randomized into the HILT (n = 21) and TENS+US (n = 21) groups. Group 1 received 3 sessions of HILT per week for 3 weeks in addition to a therapeutic exercise program that performed 5 sessions per week for 3 weeks. Group 2 received conventional physical therapy and a therapeutic exercise program for HSP of 5 sessions per week for 3 weeks. Patients were assessed before and after treatment on the on the 6th week for radiological evaluation with ultrasonography and for clinical parameters with VAS, AMAT, MRS, and FIQ scores.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed case of HSP,
- •First-ever unilateral stroke,
- •Visual analog scale (VAS) ≥30 mm,
- •Time since stroke ≥6 months,
- •Time since last local intervention treatment >6 months.
Exclusion Criteria
- •A history of shoulder pain prior to stroke;
- •An unstable medical condition or uncontrolled systemic diseases (such as respiratory failure, congestive heart failure, liver and kidney dysfunction, or any other disorders affecting neuromuscular function);
- •Bilateral hemiplegia;
- •Cardiac pacemakers;
- •Disturbance of awareness, severe visual and cognitive impairment, Mini-Mental State Examination score: <23 points
Arms & Interventions
group 1: high intensive laser
HILT was applied 3 times per week, totaling 9 sessions for three weeks.
Intervention: high intensity laser (Device)
group 2: TENS+Ultrasound
tens+us used combined. 5 times per week. total 15 sessions for three weeks
Intervention: tens+us (Device)
Outcomes
Primary Outcomes
arm motor ability test
Time Frame: before treatment(baseline), after treatment
this scale asses the upper extremity motor function improvement and daily living activity level , between 0 is the worst score, mean is cant do/use, 5 is the best score.(between 0-5)
modified ranking scale
Time Frame: before treatment(baseline), after treatment
determines the patient's addiction level and evaluates disability; the score is between 0 and 6, where 0 is complete well-being, 5 is very severe disorder and 6 is full dependency
visual analog scale
Time Frame: before treatment(baseline), after treatment
pain level, between 0-10, 0 is no pain, 10 is very severe pain
functional indepandance measures
Time Frame: before treatment(baseline), after treatment
functional capacity assessment scale;and despite indepandance of daily living activity 0-126, high score is better function
Secondary Outcomes
- ultrasonographic imaging(before treatment(baseline), after treatment)