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Completed

NCT Number: NCT06407596

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

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.

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Key information

Conditions

Hemiplegic Shoulder Pain Hemiplegia High Intensity Laser Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Physical Therapy Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high intensity laser

Device

3 times per week, for 9 sessions

tens+us

Device

5 times per week, total 15 sessions for 3 weeks

Primary outcomes

  1. visual analog scale

    Time frame: before treatment(baseline), after treatment

    pain level, between 0-10, 0 is no pain, 10 is very severe pain

  2. arm motor ability test

    Time frame: 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)

  3. functional indepandance measures

    Time frame: before treatment(baseline), after treatment

    functional capacity assessment scale;and despite indepandance of daily living activity 0-126, high score is better function

  4. modified ranking scale

    Time frame: 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

Secondary outcomes

  1. ultrasonographic imaging

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 9, 2024
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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