High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain

Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04669405
Collaborator
(none)
44
1
2
17.1
2.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: High intensity laser therapy
  • Other: Therapeutic Exercise
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain: A Prospective Randomized Controlled Study
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Sep 1, 2020
Actual Study Completion Date :
Sep 1, 2020

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Pain of the hemiplegic shoulder [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

    Secondary Outcome Measures

    1. Range of motion (ROM) of the hemiplegic shoulder [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.

    2. Shoulder functional status (SPADI) [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

    3. Motor recovery [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

    4. Spastisity [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.

    5. Functional status (FIM) [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

    6. Quality of life of the hemiplegic patient [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

    7. Rotator cuff tear size [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gaziler Physical Medicine and Rehabilitation Education and Research Hospital Ankara Turkey 06800

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yasin Demir, Physical Medicine and Rehabilitation Specialist, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04669405
    Other Study ID Numbers:
    • 7
    First Posted:
    Dec 16, 2020
    Last Update Posted:
    Dec 17, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yasin Demir, Physical Medicine and Rehabilitation Specialist, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 17, 2020