High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain

NCT04669405 | Completed

• 1 other identifier: 7
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

High intensity laser therapy (HILT) has been considered as a treatment option for shoulder pain. To our knowledge, the effectiveness of HILT in patients with hemiplegic shoulder pain (HSP) with partial thickness rotator cuff tear (PTRCT) is unknown. 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

Hemiplegia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain of the hemiplegic shoulder

  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 Outcomes (7)

• Range of motion (ROM) of the hemiplegic shoulder

  Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder ROM of the patients at 3 weeks

• Shoulder functional status (SPADI)

  Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder functional status of the patients at 3 weeks

• Motor recovery

  Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm motor recovery of the patients at 3 weeks

• Spastisity

  Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm spasticity of the patients at 3 weeks

• Functional status (FIM)

  Through study completion, an average of 3 weeks (Change from baseline functional status of the patients at 3 weeks

Study Arms (2)

HILT group

ACTIVE COMPARATOR

Patients with hemiplegic shoulder pain with partial thickness rotator cuff receiving high intensity laser therapy.

Device: High intensity laser therapy; Other: Therapeutic Exercise

Control group

OTHER

Patients with hemiplegic shoulder pain with partial thickness rotator cuff receiving exercise.

Other: Therapeutic Exercise

Interventions

High intensity laser therapy DEVICE

A prospective, randomized, controlled study was undertaken. A total of 44 patients who met inclusion criteria were randomly divided into two groups. HILT group (n=22) received 3 sessions of HILT per week for 3 weeks in addition to the multidisciplinary stroke rehabilitation and exercise program which performed 5 sessions per week for 3 weeks. Control group (n=22) received a multidisciplinary stroke rehabilitation and exercise program for HSP of 5 sessions per week for 3 weeks.

Also known as: Rehabilitation program

HILT group

Therapeutic Exercise OTHER

A prospective, randomized, controlled study was undertaken. A total of 44 patients who met inclusion criteria were randomly divided into two groups. HILT group (n=22) received 3 sessions of HILT per week for 3 weeks in addition to the multidisciplinary stroke rehabilitation and exercise program which performed 5 sessions per week for 3 weeks. Control group (n=22) received a multidisciplinary stroke rehabilitation and exercise program for HSP of 5 sessions per week for 3 weeks.

Also known as: Rehabilitation program

Control group; HILT group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with HSP (at least 4/10 points from VAS) aged 18-75 years with hemiplegia duration\> 6 months, suffered a stroke resulting in unilateral hemiplegia for the first time, and who had partial thickness RCT after ultrasonographic evaluation due to shoulder pain

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

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (1)

• Korkmaz N, Gurcay E, Demir Y, Tezen O, Korkmaz I, Atar MO, Yasar E. The effectiveness of high-intensity laser therapy in the treatment of post-stroke patients with hemiplegic shoulder pain: a prospective randomized controlled study. Lasers Med Sci. 2022 Feb;37(1):645-653. doi: 10.1007/s10103-021-03316-y. Epub 2021 Apr 8.

  PMID: 33829317 DERIVED

MeSH Terms

Conditions

Hemiplegia; Rotator Cuff Injuries; Motor Activity

Interventions

Rehabilitation; Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Physical Therapy Modalities

Study Officials

• Evren Yaşar, MD

  Health Sciences University, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  STUDY DIRECTOR

• Nurdan Korkmaz, MD

  Health Sciences University, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 16, 2020
• Study Start: April 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)