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High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain

Primary Purpose

Shoulder Pain, Hemiplegia, Arthralgia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
High intensity laser therapy
Therapeutic Exercise
Sponsored by
Afyonkarahisar Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring hemiplehic shoulder pain, rotator cuff tear, high intensity laser therapy, exercise, ultrasound

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with HSP aged 50-85 years with hemiplegia duration> 2 months, suffered a stroke resulting in unilateral hemiplegia for the first time

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

Sites / Locations

  • Afyonkarahisar Health Sciences UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High intensity laser therapy + exercise

Exercise only

Arm Description

HILT will be applied to the patients five times a week for a period of three weeks and one session per day for a total of 15 sessions by a physical therapy technician who is experienced in using a laser device. (BTL-6000 high intensity laser 12 W, Stevenage, Hertfordshire, England). The laser device generates a maximum power of 12 W and emits a wavelength of 1064 nm (Nd: YAG laser). In the HILT group, it will be used in the rotator cuff muscles area in two stages, Phase I and Phase II. For analgesic effect in phase I. Phase II will also be applied for the biostimulation effect. Exercise program was applied in five sessions a week for three weeks, with a total of 15 sessions a day.

Exercise program was applied in five sessions a week for three weeks, with a total of 15 sessions a day.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)
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

Range of motion (ROM) of the hemiplegic shoulder
Passive ROM measurements of shoulder external rotation, abduction, and flexion movements were recorded by a universal goniometer.
Shoulder Pain and Disability Index (SPADI)
The SPADI is a joint-specific measure focusing on pain and functional activities involving the shoulder.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
Spastisity
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. Higher scores indicate severe spasticity.
Functional status (FIM)
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
Quality of life of the hemiplegic patient
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
Fugl Meyer Assessment (upper extremity)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.The FM scale is divided into 5 areas: motor function, sensory function, balance, range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ranking scale (0 = unable to perform, 1 = partially performs, 2 = fully performs).Higher scores is better.

Full Information

First Posted
September 29, 2022
Last Updated
September 29, 2022
Sponsor
Afyonkarahisar Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05564182
Brief Title
High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain
Official Title
Efficacy of High Intensity Laser Treatment in Hemiplegic Shoulder Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2022 (Actual)
Primary Completion Date
December 10, 2022 (Anticipated)
Study Completion Date
February 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Afyonkarahisar Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
High intensity laser therapy (HILT) has been considered as a treatment option for shoulder pain. In randomized controlled studies with high-intensity laser therapy (HILT), there are publications showing its effectiveness in conditions such as shoulder pathologies such as subacromial impigment syndrome and adhesive capsulitis. However, there are few studies in the literature that focus on the effectiveness of HILT, especially in hemiplegic shoulder pain. 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.
Detailed Description
The study was designed as prospective, randomized, controlled trial. Patients with HSP accompanied by PTRCT (n=40) were randomly assigned to HILT and control groups. Group 1 (HILT group, n=20) 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=20) 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,Fugl Meyer Assessment, Brunnstrom Stages, Modified Ashworth Scale (MAS) Nottingham Health Profile (NHP).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Hemiplegia, Arthralgia, Joint Diseases, Musculoskeletal Diseases
Keywords
hemiplehic shoulder pain, rotator cuff tear, high intensity laser therapy, exercise, ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High intensity laser therapy + exercise
Arm Type
Experimental
Arm Description
HILT will be applied to the patients five times a week for a period of three weeks and one session per day for a total of 15 sessions by a physical therapy technician who is experienced in using a laser device. (BTL-6000 high intensity laser 12 W, Stevenage, Hertfordshire, England). The laser device generates a maximum power of 12 W and emits a wavelength of 1064 nm (Nd: YAG laser). In the HILT group, it will be used in the rotator cuff muscles area in two stages, Phase I and Phase II. For analgesic effect in phase I. Phase II will also be applied for the biostimulation effect. Exercise program was applied in five sessions a week for three weeks, with a total of 15 sessions a day.
Arm Title
Exercise only
Arm Type
Active Comparator
Arm Description
Exercise program was applied in five sessions a week for three weeks, with a total of 15 sessions a day.
Intervention Type
Device
Intervention Name(s)
High intensity laser therapy
Intervention Description
HILT will be applied to the patients five times a week for a period of three weeks and one session per day for a total of 15 sessions by a physical therapy technician who is experienced in using a laser device (BTL-6000 high intensity laser 12 W, Stevenage, Hertfordshire, England). It will be used in the rotator cuff muscles area in two stages, Phase I and Phase II. For analgesic effect in phase I. Phase II will also be applied for the biostimulation effect.
Intervention Type
Other
Intervention Name(s)
Therapeutic Exercise
Intervention Description
Therapeutic Exercise As therapeutic exercise program; A multidisciplinary stroke rehabilitation program will be implemented in the presence of a specialist physiotherapist. In addition, a therapeutic exercise program including passive, actively supported and active ROM exercises, stretching, strengthening and mobilization exercises will be applied to all patients by physiotherapists according to the level of pain and limitation.It was planned to implement a total of 15 sessions 5 days a week for 3 weeks, for approximately 30 minutes.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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
Time Frame
Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder pain of the patients at 3 weeks
Secondary Outcome Measure Information:
Title
Range of motion (ROM) of the hemiplegic shoulder
Description
Passive ROM measurements of shoulder external rotation, abduction, and flexion movements were recorded by a universal goniometer.
Time Frame
Time Frame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder ROM of the patients at 3 weeks
Title
Shoulder Pain and Disability Index (SPADI)
Description
The SPADI is a joint-specific measure focusing on pain and functional activities involving the shoulder.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
Time Frame
Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm motor recovery of the patients at 3 weeks
Title
Spastisity
Description
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. Higher scores indicate severe spasticity.
Time Frame
Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm spasticity of the patients at 3 weeks
Title
Functional status (FIM)
Description
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
Time Frame
Through study completion, an average of 3 weeks (Change from baseline functional status of the patients at 3 weeks
Title
Quality of life of the hemiplegic patient
Description
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
Time Frame
Through study completion, an average of 3 weeks (Change from baseline quality of life of the patients at 3 weeks
Title
Fugl Meyer Assessment (upper extremity)
Description
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.The FM scale is divided into 5 areas: motor function, sensory function, balance, range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ranking scale (0 = unable to perform, 1 = partially performs, 2 = fully performs).Higher scores is better.
Time Frame
Through study completion, an average of 3 weeks (Change from baseline quality of life of the patients at 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with HSP aged 50-85 years with hemiplegia duration> 2 months, suffered a stroke resulting in unilateral hemiplegia for the first time 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
Facility Information:
Facility Name
Afyonkarahisar Health Sciences University
City
Afyonkarahisar
ZIP/Postal Code
03200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nur Doğanlar
Phone
05462861805
Email
ndoganlar03@gmail.com
First Name & Middle Initial & Last Name & Degree
Nuran Eyvaz
Phone
05334262442
Email
n_eyvaz@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23192716
Citation
Viana R, Pereira S, Mehta S, Miller T, Teasell R. Evidence for therapeutic interventions for hemiplegic shoulder pain during the chronic stage of stroke: a review. Top Stroke Rehabil. 2012 Nov-Dec;19(6):514-22. doi: 10.1310/tsr1906-514.
Results Reference
background
PubMed Identifier
26504346
Citation
Tao W, Fu Y, Hai-Xin S, Yan D, Jian-Hua L. The application of sonography in shoulder pain evaluation and injection treatment after stroke: a systematic review. J Phys Ther Sci. 2015 Sep;27(9):3007-10. doi: 10.1589/jpts.27.3007. Epub 2015 Sep 30.
Results Reference
background
PubMed Identifier
30572425
Citation
Song HJ, Seo HJ, Lee Y, Kim SK. Effectiveness of high-intensity laser therapy in the treatment of musculoskeletal disorders: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Dec;97(51):e13126. doi: 10.1097/MD.0000000000013126. Erratum In: Medicine (Baltimore). 2019 Jan;98(4):e14274.
Results Reference
background

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High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain

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