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

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

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 Overview

• Status: Completed
• Conditions: Hemiplegia; Physical Therapy; Hemiplegic Shoulder Pain; High Intensity Laser
• Intervention / Treatment: Device: high intensity laser; Device: tens+us

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06800
      • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale	pain level, between 0-10, 0 is no pain, 10 is very severe pain	before treatment(baseline), after treatment
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Paralysis; Shoulder Pain; Hemiplegia
• Other Study ID Numbers: is E2-22-1902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No