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Clinical Trials/NCT04758182
NCT04758182UnknownNot Applicable

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

Siriraj Hospital2 sites in 1 country34 target enrollmentStarted: February 27, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
34
Locations
2
Primary Endpoint
Pain: Numeric rating scale

Study Overview

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.

Detailed Description

Hemiplegic shoulder pain is a common clinical consequence of stroke and can result in significant disability. Shoulder pain can negatively affect rehabilitation outcomes as good shoulder function is a prerequisite for successful transfers, maintaining balance, effective hand function, and performing activities of daily living. The reported prevalence of shoulder pain varies between 5% and 84%, depending on timing and definition of shoulder pain used. An incidence of hemiplegic shoulder pain during the first year range from 1% to 22%. Causes of hemiplegic shoulder pain are multifactorial. Pain is associated with shoulder tissue injury, abnormal joint mechanics, and central nociceptive hypersensitivity. About one third of patients with acute stroke have abnormal ultrasound findings in the hemiplegic shoulder when studied at the time of admission to acute inpatient rehabilitation, including effusion in biceps tendon or subacromial bursa; tendinopathy of biceps, supraspinatus, or subscapularis; and rotator cuff tear 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. Well- known interventions for Hemiplegic shoulder pain includes botulinum toxin injection, intraarticular steroid injection and transcutaneous electrical nerve stimulation. Nowadays, there are high technology modalities which are less invasive such as ultrasound therapy, extracorporeal shockwave therapy, repetitive transcranial magnetic stimulation and laser therapy.

Ultrasound therapy is frequently used to relieve pain in hemiplegic shoulder; although there were limited evidences of benefit of ultrasound in hemiplegic shoulder. Randomized control trials in 2010 showed that ultrasound therapy significantly reduce pain and increase pain free ROM of post stroke shoulder pain.

However from previous study in1972 showed that ultrasound dose not significantly increases pain free range of motion in the involved shoulders of patients with hemiplegia.

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. In the central nervous system, laser therapy centrally inhibits pain sensation by increasing the secretion of endogenous opioids such as b-endorphins. In the peripheral nervous system, laser therapy has been reported to decrease the secretion of substance P by peripheral receptors. Laser therapy might increase the latency and decrease the conduction velocity of sensory nerves by inhibiting Aδ- and C-fiber transmission; these in turn may decrease the transmission of pain signals. In tissues, laser therapy may also reduce the release of histamine and bradykinin in injured tissues and increase the pain threshold. HILT increases cell metabolism, vascular permeability, and blood flow in deep tissue structures. Compared to low level laser therapy, HILT have a shorter laser emission time and a longer laser emission interval. Therefore, a large amount of laser irradiation can be delivered to deep tissues.

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. From this study there was insufficient evidence to conclude the efficacy of HILT on shoulder pain. However, in randomized controlled trial which studied the efficacy of HILT in patients with subacromial impingement syndrome showed greater reduction in pain, improvement in articular movement and muscle strength of the affected shoulder after 10 treatment sessions of HILT than did participants receiving Ultrasound therapy over a period of 2 consecutive weeks. In management of frozen shoulder, HILT (3 times per week for 3 weeks) provided significant pain relief at 3 and 8 weeks, but not at the final follow-up time point ( 12 weeks).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

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

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age > 18 years
  • 1st 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.

Exclusion Criteria

  • Patients with pacemaker
  • 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

Outcomes

Primary Outcomes

Pain: Numeric rating scale

Time Frame: 2 weeks

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%

Secondary Outcomes

  • Shoulder passive range of motion(2 weeks)
  • Brunnstrom classification of arm and hand(2 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kanyakorn Buspavanich

KANYAKORN BUSPAVANICH M.D.

Siriraj Hospital

Study Sites (2)

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