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

NCT06407596 | Completed

• 1 other identifier: is E2-22-1902
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• ultrasonographic imaging

  before treatment(baseline), after treatment

Study Arms (2)

group 1: high intensive laser

EXPERIMENTAL

HILT was applied 3 times per week, totaling 9 sessions for three weeks.

Device: high intensity laser

group 2: TENS+Ultrasound

EXPERIMENTAL

tens+us used combined. 5 times per week. total 15 sessions for three weeks

Device: tens+us

Interventions

high intensity laser DEVICE

3 times per week, for 9 sessions

group 1: high intensive laser

tens+us DEVICE

5 times per week, total 15 sessions for 3 weeks

group 2: TENS+Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: May 9, 2024
• Study Start: June 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: August 30, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)