High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain

Shoulder Pain Clinical Trial

Official title:

Efficacy of High Intensity Laser Treatment in Hemiplegic Shoulder Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05564182
• Other study ID #: HILT2022
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2022
• Est. completion date: February 10, 2023

Study information

• Verified date: September 2022
• Source: Afyonkarahisar Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 10, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Hemiplegia
• Joint Diseases
• Musculoskeletal Diseases
• Shoulder Pain

Intervention

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.

Locations

Country	Name	City	State
Turkey	Afyonkarahisar Health Sciences University	Afyonkarahisar

Sponsors (1)

Lead Sponsor	Collaborator
Afyonkarahisar Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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