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

Hemiplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06407596
• Other study ID #: is E2-22-1902
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hemiplegia
• Hemiplegic Shoulder Pain
• Physical Therapy
• Shoulder Pain

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