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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06407596
Enrollment
42
Registered
2024-05-09
Start date
2022-06-01
Completion date
2023-08-30
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegic Shoulder Pain, Hemiplegia, Physical Therapy, High Intensity Laser

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.

Interventions

3 times per week, for 9 sessions

DEVICEtens+us

5 times per week, total 15 sessions for 3 weeks

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
visual analog scalebefore treatment(baseline), after treatmentpain level, between 0-10, 0 is no pain, 10 is very severe pain
arm motor ability testbefore treatment(baseline), after treatmentthis 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)
functional indepandance measuresbefore treatment(baseline), after treatmentfunctional capacity assessment scale;and despite indepandance of daily living activity 0-126, high score is better function
modified ranking scalebefore treatment(baseline), after treatmentdetermines 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

Secondary

MeasureTime frameDescription
ultrasonographic imagingbefore treatment(baseline), after treatmentmuscle-skeletal ultrasonographic imaging;ultrasonographic findings; SA-SD bursitis, Bicipital tenosynovitis, Tendinosis, Cortical irregularity, Partial rupture, Total rupture, ACJ joint hypertrophy, Calcific tendinitis.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026