High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain

Efficacy of High Intensity Laser Treatment in Hemiplegic Shoulder Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Hemiplegia
• Intervention / Treatment: Device: High intensity laser therapy; Other: Therapeutic Exercise

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).

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Afyonkarahisar, Turkey, 03200
    • Recruiting
    • Afyonkarahisar Health Sciences University
    • Contact: Nur Doğanlar; Phone Number: 05462861805; Email: ndoganlar03@gmail.com
    • Contact: Nuran Eyvaz; Phone Number: 05334262442; Email: n_eyvaz@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High intensity laser therapy + exercise; 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.	Device: High intensity laser therapy; 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.; Other: Therapeutic Exercise; 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.
Active Comparator: Exercise only; Exercise program was applied in five sessions a week for three weeks, with a total of 15 sessions a day.	Other: Therapeutic Exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
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	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	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
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.	Time Frame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder ROM of the patients at 3 weeks
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	Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm motor recovery of the patients at 3 weeks
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.	Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm spasticity of the patients at 3 weeks
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.	Through study completion, an average of 3 weeks (Change from baseline quality of life of the patients at 3 weeks

Collaborators and Investigators

• Sponsor: Afyonkarahisar Health Sciences University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2022
• Primary Completion (Anticipated): December 10, 2022
• Study Completion (Anticipated): February 10, 2023

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: rotator cuff tear; exercise; ultrasound; hemiplehic shoulder pain; high intensity laser therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Paralysis; Arthralgia; Joint Diseases; Shoulder Pain; Musculoskeletal Diseases; Hemiplegia
• Other Study ID Numbers: HILT2022

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