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Clinical Trials/NCT06407596
NCT06407596
Completed
Not Applicable

High-intensity Laser Therapy (HILT) or Conventional Combined Physical Therapy in the Management of Hemiplegic Shoulder Pain ; Randomized Controlled Trial

Ankara City Hospital Bilkent1 site in 1 country42 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemiplegic Shoulder Pain
Sponsor
Ankara City Hospital Bilkent
Enrollment
42
Locations
1
Primary Endpoint
arm motor ability test
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
August 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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)

Study Sites (1)

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