Subacromial Impingement Syndrome Approach Using High Intensity Laser Therapy

Effectiveness of High Intensity Laser Therapy in the Treatment of Subacromial Impingement Syndrome

The purpose of this study is to assess the effectiveness of high intensity laser therapy in the treatment of subacromial impingement syndrome.

Study Overview

• Status: Completed
• Conditions: Subacromial Impingement
• Intervention / Treatment: Device: iLux Laser; Device: Sham ilux Laser

Detailed Description

Shoulder pain has a high prevalence in our society, several studies estimate an annual prevalence between 5% and 47%. It is one of the main causes of musculoskeletal pain, particularly in third place, after the low back pain and neck pain.

Symptoms of pathologies of subacromial space impingement syndrome, where, regardless of origin, pain is the number one symptom for the patient, which emanates functional impairment and the impact on quality of life. Because of the need to implement research to assess the effectiveness of high intensity laser therapy with new studies mayor methodological quality of obtaining conclusive results, and based on the scientific evidence supporting the low-power laser therapy as a useful tool in addressing the shoulder tendon pathology, we consider very interesting the realization of this research project.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Toledo
    • Talavera de la Reina, Toledo, Spain, 45600
      • Hospital General Nuestra Señora del Prado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients between 18 and 75 years old with diagnosis of subacromial impingement syndrome or any of the pathologies that compose it (tendinosis-tendinitis supraspinatus and rest of the rotator cuff, subacromial bursitis and tendinitis of the long head of the biceps).
• Visual Analogue Scale (VAS) less than or equal to 7.
• Forward flexion at least of 100º

Exclusion Criteria:

• Calcific tendinitis
• Complete rupture of the rotator cuff.
• Adhesive capsulitis.
• Clinical history of pathologies that without affecting the shoulder joint refer to painful shoulder symptoms (cervical root involvement, cervical surgery, cervical osteoarthritis and neurological pathologies)
• Fibromyalgia
• Be receiving physiotherapeutic treatment or have received it previously for this pathology one month before the start of treatment.
• Patients with alterations of thermal sensitivity.
• Derived from the absolute and relative contraindications of Laser Therapy:
• Photosensitive patients
• Neoplastic processes
• Hyperthyroidism
• Pregnancy
• Patients with a history of epileptic seizures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-intensity laser therapy; High-intensity laser therapy application through iLux Laser device	Device: iLux Laser; Treatment during 15 sessions. It is divided in two phases: 1. 12W. 50 Hz 20% duty cycle. 50 J/cm² in painful zone. 2. 15 W. Burst (10 pulses-900 msec each train) 250 J/cm² in painful zone. Trough the iLux Laser (Mectronic Medicale, Italy) + Physical Therapy protocol.
Sham Comparator: Sham device; Sham high-intensity laser therapy application through sham iLux Laser device	Device: Sham ilux Laser; Sham treatment during 15 sessions trough the iLux Laser (Mectronic Medicale, Italy), It is applies the same time than experimental one but with 0 W + Physical Therapy protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain and Disability Index (SPADI)	SPADI test	Baseline
Shoulder Pain and Disability Index (SPADI)	SPADI test	At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-)
Shoulder Pain and Disability Index (SPADI)	SPADI test	one month after the end of the protocol treatment
Shoulder Pain and Disability Index (SPADI)	SPADI test	three months after the end of the protocol treatment
Constant-Murley Score	Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.	Baseline
Constant-Murley Score	Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.	At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-)
Constant-Murley Score	Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.	one month after the end of the protocol treatment
Constant-Murley Score	Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.	three months after the end of the protocol treatment
Quick-Dash Abbreviated	Quick- Dash Abbreviated test	Baseline
Quick-Dash Abbreviated	Quick- Dash Abbreviated test	At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-)
Quick-Dash Abbreviated	Quick- Dash Abbreviated test	one month after the end of the protocol treatment
Quick-Dash Abbreviated	Quick- Dash Abbreviated test	three months after the end of the protocol treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Painful pressure threshold	The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.	Baseline, at the of the 15 sessions, one month after the end of the protocol treatment, three months after the end of the protocol treatment
Painful pressure threshold after first session	The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.	First session - 15 minutes after laser or sham treatment.
VAS	Visual analogue scale	Baseline, at the of the 15 sessions, one month after the end of the protocol treatment, three months after the end of the protocol treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	EQ-5D™ is a standardised instrument for use as a measure of health outcome.	Baseline

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Collaborators: Castilla-La Mancha Health Service; Hospital General Nuestra Señora del Prado
• Investigators: Principal Investigator: Javier Aceituno-Gomez, PT, Castilla-La Mancha Health Service

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: November 15, 2016
• First Submitted That Met QC Criteria: November 19, 2016
• First Posted (Estimate): November 22, 2016

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: jagHNSP