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Completed

NCT Number: NCT05564182

High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain

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.

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Key information

Conditions

Shoulder Pain Arthralgia Behavior Hemiplegia Joint Diseases Motor Activity Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Paralysis Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rupture Shoulder Injuries Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03200, Turkey (Türkiye)

About this study

The study was designed as prospective, randomized, controlled trial. Participants 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Visual Analog Scale (VAS)

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

    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 outcomes

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

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

    Passive ROM measurements of shoulder external rotation, abduction, and flexion movements were recorded by a universal goniometer.

  2. Shoulder Pain and Disability Index (SPADI)

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

    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

  3. Spastisity

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

    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.

  4. Functional status (FIM)

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

    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

  5. Quality of life of the hemiplegic patient

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

    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

  6. Fugl Meyer Assessment (upper extremity)

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

    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.

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study title

Efficacy of High Intensity Laser Treatment in Hemiplegic Shoulder Patients

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 3, 2022
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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