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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06407596
Other study ID # is E2-22-1902
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date August 30, 2023

Study information

Verified date May 2024
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date August 30, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosed case of HSP, - Age =18, - 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

Study Design


Intervention

Device:
high intensity laser
3 times per week, for 9 sessions
tens+us
5 times per week, total 15 sessions for 3 weeks

Locations

Country Name City State
Turkey Ankara City Hospital Ankara Çankaya

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary visual analog scale pain level, between 0-10, 0 is no pain, 10 is very severe pain before treatment(baseline), after treatment
Primary arm motor ability test 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) before treatment(baseline), after treatment
Primary functional indepandance measures functional capacity assessment scale;and despite indepandance of daily living activity 0-126, high score is better function before treatment(baseline), after treatment
Primary modified ranking scale 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 before treatment(baseline), after treatment
Secondary ultrasonographic imaging muscle-skeletal ultrasonographic imaging;ultrasonographic findings; SA-SD bursitis, Bicipital tenosynovitis, Tendinosis, Cortical irregularity, Partial rupture, Total rupture, ACJ joint hypertrophy, Calcific tendinitis. before treatment(baseline), after treatment
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