High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain

Hemiplegia Clinical Trial

Official title:

The Effectiveness of High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain: A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04669405
• Other study ID #: 7
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: December 2020
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Shoulder Pain

Intervention

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:
• 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.

Locations

Country	Name	City	State
Turkey	Gaziler Physical Medicine and Rehabilitation Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder ROM of the patients at 3 weeks
Secondary	Shoulder functional status (SPADI)	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 shoulder functional status of the patients at 3 weeks
Secondary	Motor recovery	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	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.	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	Rotator cuff tear size	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	Through study completion, an average of 3 weeks (Change from baseline rotator tear cuff size of the patients at 3 weeks