High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain

NCT05564182 | Completed

• 1 other identifier: HILT2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Diseases; Shoulder Pain; Hemiplegia; Arthralgia; Joint Diseases

Keywords

hemiplehic shoulder pain; rotator cuff tear; high intensity laser therapy; exercise; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline (pre-treatment), immediately post-treatment, and at 3-week follow-up (Change in hemiplegic shoulder pain from baseline)

Secondary Outcomes (6)

• Range of motion (ROM) of the hemiplegic shoulder

  Baseline (pre-treatment), immediately post-treatment, and at 3-week follow-up (Change in hemiplegic shoulder ROM from baseline)

• Shoulder Pain and Disability Index (SPADI)

  Baseline (pre-treatment), immediately post-treatment, and at 3-week follow-up (Change in hemiplegic arm motor recovery from baseline)

• Spastisity

  Baseline (pre-treatment), immediately post-treatment, and at 3-week follow-up (Change in hemiplegic arm spasticity from baseline)

• Functional status (FIM)

  Baseline (pre-treatment), immediately post-treatment, and at 3-week follow-up (Change in functional status from baseline)

• Quality of life of the hemiplegic patient

  Baseline (pre-treatment), immediately post-treatment, and at 3-week follow-up (Change in quality of life from baseline)

Study Arms (2)

High intensity laser therapy + exercise

EXPERIMENTAL

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; Other: Therapeutic Exercise

Exercise only

ACTIVE COMPARATOR

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

Other: Therapeutic Exercise

Interventions

Therapeutic Exercise OTHER

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.

Exercise only; High intensity laser therapy + exercise

High intensity laser therapy DEVICE

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.

High intensity laser therapy + exercise

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03200, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 23192716 BACKGROUND

• 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.

  PMID: 26504346 BACKGROUND

• 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.

  PMID: 30572425 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Hemiplegia; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Rotator Cuff Injuries; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis; Nervous System Diseases; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 3, 2022
• Study Start: September 10, 2022
• Primary Completion: December 10, 2022
• Study Completion: February 10, 2023
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)