Effects of High Intensity Laser Therapy Compared With Ultrasound Therapy on Hemiplegic Shoulder Pain; Randomized Control Trial

NCT04758182 | Unknown

• 1 other identifier: 053/2563
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Hemiplegic shoulder pain is a common clinical consequence of stroke and can result in significant disability.There are several treatments for Hemiplegic shoulder pain. Patient and family education (ie, range of motion and positioning) is recommended for shoulder pain and shoulder care after stroke, particularly before discharge or transitions in care. Ultrasound therapy is frequently used to relieve pain in hemiplegic shoulder; although there were limited evidences of benefit of ultrasound in hemiplegic shoulder. Laser therapy has become increasing use in hemiplegic shoulder pain. Previous study shows that low level laser therapy significantly reduced pain and improved range of motion in hemiplegic shoulder compared with electrotherapy. High intensity laser therapy (HILT) has been known to reduce pain through multiple pathways including central nervous system pathway, peripheral nervous system pathway and tissues pathway. According to Latest systematic review and meta-analysis, HILT significantly improved pain and disability scores compared with control in musculoskeletal disease especially with neck and back pain. To the best of our knowledge, there is no clinical trial regarding the efficacy of HILT in hemiplegic shoulder pain. Therefore, the aim of our study is to investigate the beneficial effects of HILT on pain reduction, ROM and function in patients with hemiplegic shoulder pain.

Conditions

Hemiplegic Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Pain: Numeric rating scale

  In a Numerical Rating Scale (NRS), patients were asked to circle the number between 0 and 10. 0 represents 'no pain at all' whereas 10 represents 'the worst pain ever possible. Numerical Rating Scales have shown high correlations with other pain-assessment tools in several studies and it is feasible. In several studies the minimal clinically important difference of NRS is 30%

  2 weeks

Secondary Outcomes (2)

• Shoulder passive range of motion

  2 weeks

• Brunnstrom classification of arm and hand

  2 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group: HILT + sham ultrasound therapy In the experimental group, participants received HILT treatment 1 session per day over a period of 2 consecutive weeks (5 days/week); total 10 sessions. In this study we used HIRO 3.0 device applied to the hemiplegic shoulder and the area of following muscles include upper trapezius, supraspinatus, deltoid, pectoralis minor muscles and the tender points. The treatment consisted of high peak power (3kW), a wavelength of 1064 nm. Two phases of treatment were performed according to Rotator cuff tendinopathy protocol of the device. The total energy administered will be approximately 2500 J. The total treatment time was approximately 10 minutes. They also received sham ultrasound therapy, which performed by applying probe with gel without turning on the device, for 10 minutes.

Device: High intensity laser therapy

Control group

ACTIVE COMPARATOR

Control group: sham HILT + ultrasound therapy In control group, participants received continuous ultrasound therapy for 10 minutes in the same area as an experimental group with Chattanooga intellect mobile ultrasound device. The device was operated at the frequency of 1 MHz, an intensity of 2 W/cm2 and a duty cycle of 100% in the same area of the HILT group. They also received sham HILT, by applying the applicator with pre-recorded sound without starting the device, for 10 minutes. Ultrasound therapy and sham ultrasound were delivered according to the predefined protocol by the physiotherapists. Both groups received 3 ROM exercise sessions per day. Participants and their caregiver were educated about proper positioning and manual handling

Device: Ultrasound therapy

Interventions

High intensity laser therapy DEVICE

Device: HIRO 3.0 device high peak power (3kW), a wavelength of 1064 nm

Also known as: HILT

Experimental group

Ultrasound therapy DEVICE

Device: Chattanooga intellect mobile ultrasound device frequency of 1 MHz, an intensity of 2 W/cm2 and a duty cycle of 100%

Control group

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• st or recurrent stroke onset within 1 year
• Hemiplegia due to stroke with pain and limited range of motion on the shoulder on the affected side
• Pain score (Numeric rating scale) ≥ 3
• Stable medical and neurological conditions
• Understand Thai.

You may not qualify if:

• Patients with pacemaker
• Pregnancy
• Aphasia or could not express their own pain intensity
• Patients with history of shoulder pain or limited ROM of the affected shoulder prior to stroke onset
• Patients who had history of trauma or surgery of the shoulder on the affected side
• Infection or malignancy at the area around affected shoulder
• central post-stroke pain or complex regional pain syndrome
• TMSE \< 24

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Faculty of medicine Siriraj hospital

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Interventions

Ultrasonic Therapy

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Central Study Contacts

Kanyakorn Buspavanich, MD.

CONTACT

+66 891408661; kanyakorn_kus34@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were blinded; participants in experimental group were received HILT and sham ultrasound, while participants in control group were received ultrasound and sham HILT. Outcome assessor was blinded to the treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: KANYAKORN BUSPAVANICH M.D.

Model Details: Double blinded randomize control trial

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 17, 2021
• Study Start: February 27, 2020
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)