High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain

• ClinicalTrials.gov Identifier: NCT04669405
• Recruitment Status: Completed
• First Posted: December 16, 2020
• Last Update Posted: December 17, 2020
• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Information provided by (Responsible Party): Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hemiplegia	Device: High intensity laser therapy; Other: Therapeutic Exercise	Not Applicable

Detailed Description:

The study was designed as prospective, randomized, controlled trial. Patients with HSP accompanied by PTRCT (n=44) were randomly assigned to HILT and control groups. Group 1 (HILT group, n=22) 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=22) 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effectiveness of High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain: A Prospective Randomized Controlled Study
• Actual Study Start Date: April 1, 2019
• Actual Primary Completion Date: September 1, 2020
• Actual Study Completion Date: September 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: HILT group; Patients with hemiplegic shoulder pain with partial thickness rotator cuff receiving high intensity laser therapy.	Device: High intensity laser therapy; 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.; Other Name: Rehabilitation program; Other: Therapeutic Exercise; 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.; Other Name: Rehabilitation program
Control group; Patients with hemiplegic shoulder pain with partial thickness rotator cuff receiving exercise.	Other: Therapeutic Exercise; 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.; Other Name: Rehabilitation program

Outcome Measures

Primary Outcome Measures :

1. Pain of the hemiplegic shoulder [ Time Frame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder pain of the patients at 3 weeks ]
   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 Outcome Measures :

1. Range of motion (ROM) of the hemiplegic shoulder [ Time Frame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder ROM of the patients at 3 weeks ]
   Passive ROM measurements of shoulder external rotation, abduction, and flexion movements were recorded by a universal goniometer.
2. Shoulder functional status (SPADI) [ Time Frame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder functional status of the patients at 3 weeks ]
   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. Motor recovery [ Time Frame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm motor recovery of the patients at 3 weeks ]
   Brunnstrom Recovery Stage (BRS) was used to appreciated the motor function level in the patients. The recovery are divided into six stages: In the 1st stage, there is complete flaccidity, and no voluntary movements in the involved body area, while the 6th stage indicates normal function
4. Spastisity [ Time Frame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm spasticity of the patients at 3 weeks ]
   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.
5. Functional status (FIM) [ Time Frame: Through study completion, an average of 3 weeks (Change from baseline functional status of the patients at 3 weeks ]
   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
6. Quality of life of the hemiplegic patient [ Time Frame: Through study completion, an average of 3 weeks (Change from baseline quality of life of the patients at 3 weeks ]
   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
7. Rotator cuff tear size [ Time Frame: Through study completion, an average of 3 weeks (Change from baseline rotator tear cuff size of the patients at 3 weeks ]
   Ultrasonographycally detected a hypoechoic / anechoic focus in the cuff material or a hypoechoic / anechoic defect in the tendon that holds the bursal or articular surface

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

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

Contacts and Locations

Locations

Turkey

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey, 06800

Sponsors and Collaborators

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

• Study Director: Evren Yaşar, MD; Health Sciences University, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Principal Investigator: Nurdan Korkmaz, MD; Health Sciences University, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Korkmaz N, Gurcay E, Demir Y, Tezen Ö, Korkmaz İ, Atar MÖ, Yaşar 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.

• Responsible Party: Yasin Demir, Physical Medicine and Rehabilitation Specialist, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• ClinicalTrials.gov Identifier: NCT04669405
• Other Study ID Numbers: 7
• First Posted: December 16, 2020
• Last Update Posted: December 17, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital:

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

Additional relevant MeSH terms:

Shoulder Pain; Hemiplegia; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Paralysis; Nervous System Diseases