HILT or Conventional Combined Physical Therapy, in the Management of Hemiplegic Shoulder Pain

Not Applicable

Completed

• Conditions: Hemiplegic Shoulder Pain; High Intensity Laser; Hemiplegia; Physical Therapy
• Interventions: Device: high intensity laser; Device: tens+us

• Registration Number: NCT06407596
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-08-30
• Study First Submitted: 2024-03-29
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-06
• Last Update Submitted: 2024-05-06
• Study First Posted: 2024-05-09
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1: high intensive laser	high intensity laser	HILT was applied 3 times per week, totaling 9 sessions for three weeks.
group 2: TENS+Ultrasound	tens+us	tens+us used combined. 5 times per week. total 15 sessions for three weeks

Primary Outcome Measures

Name	Time	Method
visual analog scale	before treatment(baseline), after treatment	pain level, between 0-10, 0 is no pain, 10 is very severe pain
arm motor ability test	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	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
functional indepandance measures	before treatment(baseline), after treatment	functional capacity assessment scale;and despite indepandance of daily living activity 0-126, high score is better function

Secondary Outcome Measures

Name	Time	Method
ultrasonographic imaging	before treatment(baseline), after treatment	muscle-skeletal ultrasonographic imaging;ultrasonographic findings; SA-SD bursitis, Bicipital tenosynovitis, Tendinosis, Cortical irregularity, Partial rupture, Total rupture, ACJ joint hypertrophy, Calcific tendinitis.

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Çankaya, Turkey