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

NCT ID: NCT06407596

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hemiplegic Shoulder Pain Hemiplegia Physical Therapy High Intensity Laser

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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group 1: high intensive laser

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

Group Type EXPERIMENTAL

high intensity laser

Intervention Type DEVICE

3 times per week, for 9 sessions

group 2: TENS+Ultrasound

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

Group Type EXPERIMENTAL

tens+us

Intervention Type DEVICE

5 times per week, total 15 sessions for 3 weeks

Interventions

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high intensity laser

3 times per week, for 9 sessions

Intervention Type DEVICE

tens+us

5 times per week, total 15 sessions for 3 weeks

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ankara City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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is E2-22-1902

Identifier Type: -

Identifier Source: org_study_id

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