HemiplegiaNCT04669405

High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain

A study testing High intensity laser therapy and Therapeutic Exercise in people with Hemiplegia, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hemiplegia
What is being tested?: High intensity laser therapy and Therapeutic Exercise
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Apr 2019to 1 Sep 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Conditions: Hemiplegia
Being tested: High intensity laser therapy, Therapeutic Exercise
Keywords: hemiplehic shoulder pain, rotator cuff tear, high intensity laser therapy, exercise, ultrasound
Medical subject headings: Hemiplegia, Rotator Cuff Injuries, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High intensity laser therapyDevice
Also called Rehabilitation program
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.
Therapeutic ExerciseOther
Also called Rehabilitation program
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.

Study groups in NCT04669405
Study group	Role	What they receive
HILT group	Active comparator	Patients with hemiplegic shoulder pain with partial thickness rotator cuff receiving high intensity laser therapy. Receives: Device: High intensity laser therapy; Other: Therapeutic Exercise
Control group	Other	Patients with hemiplegic shoulder pain with partial thickness rotator cuff receiving exercise. Receives: Other: Therapeutic Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Passive ROM measurements of shoulder external rotation, abduction, and flexion movements were recorded by a universal goniometer.
Measured: Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder ROM of the patients at 3 weeks
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
Measured: Through study completion, an average of 3 weeks (Change from baseline hemiplegic shoulder functional status of the patients at 3 weeks
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
Measured: Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm motor recovery of the patients at 3 weeks
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.
Measured: Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm spasticity of the patients at 3 weeks
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
Measured: Through study completion, an average of 3 weeks (Change from baseline functional status of the patients at 3 weeks
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
Measured: Through study completion, an average of 3 weeks (Change from baseline quality of life of the patients at 3 weeks
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
Measured: Through study completion, an average of 3 weeks (Change from baseline rotator tear cuff size of the patients at 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20191 Sep 2020

First posted16 Dec 2020
Study start1 Apr 2019
Primary completion1 Sep 2020
Study completion1 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HemiplegiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04669405
Sponsor's protocol ID: 7
Status last verified: Dec 2020
First submitted: 14 Dec 2020
Last updated: 17 Dec 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33829317

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hemiplegia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness of High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain: A Prospective Randomized Controlled Study
ClinicalTrials.gov ID: NCT04669405
Acronym / sponsor ID: 7
Conditions: Hemiplegia
Keywords: hemiplehic shoulder pain, rotator cuff tear, high intensity laser therapy, exercise, ultrasound
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
Study start: 1 Apr 2019 (actual)
Primary completion: 1 Sep 2020 (actual)
Study completion: 1 Sep 2020 (actual)
First posted: 16 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
HILT group	Active comparator	Device: High intensity laser therapy, Other: Therapeutic ExercisePatients with hemiplegic shoulder pain with partial thickness rotator cuff receiving high intensity laser therapy.
Control group	Other	Other: Therapeutic ExercisePatients with hemiplegic shoulder pain with partial thickness rotator cuff receiving exercise.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High intensity laser therapyAlso: Rehabilitation programA 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.	Device	HILT group
Therapeutic ExerciseAlso: Rehabilitation programA 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	Control group, HILT group

Primary outcome

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

7 secondary outcomes

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
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
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
Spastisity
Time frame: Through study completion, an average of 3 weeks (Change from baseline hemiplegic arm spasticity of the patients at 3 weeks
Functional status (FIM)
Time frame: Through study completion, an average of 3 weeks (Change from baseline functional status of the patients at 3 weeks
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
Derived from this study: PubMed 33829317Korkmaz 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Evren Yaşar, MD study director

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

Nurdan Korkmaz, MD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04669405, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.