High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain

December 15, 2020 updated by: Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

The Effectiveness of High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain: A Prospective Randomized Controlled Study

High intensity laser therapy (HILT) has been considered as a treatment option for shoulder pain. To our knowledge, the effectiveness of HILT in patients with hemiplegic shoulder pain (HSP) with partial thickness rotator cuff tear (PTRCT) is unknown. In this study, we intended to investigate the effectiveness of HILT on pain, disability, function and quality of life in patients with HSP accompanied by PTRCT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was designed as prospective, randomized, controlled trial. Patients with HSP accompanied by PTRCT (n=44) were randomly assigned to HILT and control groups. Group 1 (HILT group, n=22) received 3 sessions of HILT per week for 3 weeks in addition to the exercise program which performed 5 sessions per week for 3 weeks. Group 2 (Control group, n=22) received an exercise program for HSP of 5 sessions per week for 3 weeks.

Participants were evaluated with Visual Analog Scale (VAS), passive Range of Motion (ROM), Shoulder Pain and Disability Index (SPADI), Nottingham Health Profile (NHP), Functional Independence Measure (FIM) and ultrasonographic PTRCT size.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with HSP (at least 4/10 points from VAS) aged 18-75 years with hemiplegia duration> 6 months, suffered a stroke resulting in unilateral hemiplegia for the first time, and who had partial thickness RCT after ultrasonographic evaluation due to shoulder pain

Exclusion Criteria:

  • Cases who had inflammatory rheumatic disease, cervical radiculopathy, diabetes mellitus, thyroid disease, coronary heart disease, cardiac pace-maker, neurological disease, shoulder surgery, and shoulder injection in the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HILT group
Patients with hemiplegic shoulder pain with partial thickness rotator cuff receiving high intensity laser therapy.
Device: High intensity laser therapy
A prospective, randomized, controlled study was undertaken. A total of 44 patients who met inclusion criteria were randomly divided into two groups. HILT group (n=22) received 3 sessions of HILT per week for 3 weeks in addition to the multidisciplinary stroke rehabilitation and exercise program which performed 5 sessions per week for 3 weeks. Control group (n=22) received a multidisciplinary stroke rehabilitation and exercise program for HSP of 5 sessions per week for 3 weeks.
Other Names:
  • Rehabilitation program
Other: Therapeutic Exercise
A prospective, randomized, controlled study was undertaken. A total of 44 patients who met inclusion criteria were randomly divided into two groups. HILT group (n=22) received 3 sessions of HILT per week for 3 weeks in addition to the multidisciplinary stroke rehabilitation and exercise program which performed 5 sessions per week for 3 weeks. Control group (n=22) received a multidisciplinary stroke rehabilitation and exercise program for HSP of 5 sessions per week for 3 weeks.
Other Names:
  • Rehabilitation program
Other: Control group
Patients with hemiplegic shoulder pain with partial thickness rotator cuff receiving exercise.
Other: Therapeutic Exercise
A prospective, randomized, controlled study was undertaken. A total of 44 patients who met inclusion criteria were randomly divided into two groups. HILT group (n=22) received 3 sessions of HILT per week for 3 weeks in addition to the multidisciplinary stroke rehabilitation and exercise program which performed 5 sessions per week for 3 weeks. Control group (n=22) received a multidisciplinary stroke rehabilitation and exercise program for HSP of 5 sessions per week for 3 weeks.
Other Names:
  • Rehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain of the hemiplegic shoulder
Time Frame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder pain of the patients at 3 weeks
Severity of pain was assessed using the standart 10 cm VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end
Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder pain of the patients at 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion (ROM) of the hemiplegic shoulder
Time Frame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder ROM of the patients at 3 weeks
Passive ROM measurements of shoulder external rotation, abduction, and flexion movements were recorded by a universal goniometer.
Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder ROM of the patients at 3 weeks
Shoulder functional status (SPADI)
Time Frame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder functional status of the patients at 3 weeks
SPADI is self-administered questionnaire composed of 5 items assessing pain and 8 items assessing disability. The score varied from 0% to 100%, with higher scores reflected greater pain and disability
Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder functional status of the patients at 3 weeks
Motor recovery
Time Frame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm motor recovery of the patients at 3 weeks
Brunnstrom Recovery Stage (BRS) was used to appreciated the motor function level in the patients. The recovery are divided into six stages: In the 1st stage, there is complete flaccidity, and no voluntary movements in the involved body area, while the 6th stage indicates normal function
Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm motor recovery of the patients at 3 weeks
Spastisity
Time Frame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm spasticity of the patients at 3 weeks
The five-point Modified Ashworth Scale (MAS), a clinical scale ranging from 0 to 4 (0 being normal muscle tone, and 4 being rigid) was used for measuring spasticity and muscle tone.
Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm spasticity of the patients at 3 weeks
Functional status (FIM)
Time Frame: Through study completion, an average of 3 weeks (Change from baseline functional status of the patients at 3 weeks
FIM is a universal assessment tool consisting of a total of 18 items that explores an individual's several physical and social functions, such as self-care, transfer, locomotion, sphincter control, communication and social cognition. Each item is scored on a 7-point ordinal scale ranging from complete independence (score= 7) to complete dependence (score= 1). Higher FIM scores indicate higher levels of independence
Through study completion, an average of 3 weeks (Change from baseline functional status of the patients at 3 weeks
Quality of life of the hemiplegic patient
Time Frame: Through study completion, an average of 3 weeks (Change from baseline quality of life of the patients at 3 weeks
Nottingham Health Profile (NHP), a life quality test, includes 38 yes / no statements regarding pain, physical mobility, emotional reactions, sleep, social isolation and energy level. Ratings on each component are weighted to give a score between 0 and 100. Higher NHP scores show a higher level of trouble
Through study completion, an average of 3 weeks (Change from baseline quality of life of the patients at 3 weeks
Rotator cuff tear size
Time Frame: Through study completion, an average of 3 weeks (Change from baseline rotator tear cuff size of the patients at 3 weeks
Ultrasonographycally detected a hypoechoic / anechoic focus in the cuff material or a hypoechoic / anechoic defect in the tendon that holds the bursal or articular surface
Through study completion, an average of 3 weeks (Change from baseline rotator tear cuff size of the patients at 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

  • Study Director: Evren Yaşar, MD, Health Sciences University, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
  • Principal Investigator: Nurdan Korkmaz, MD, Health Sciences University, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (Actual)

December 16, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 15, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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