Subacromial Impingement Syndrome Approach Using High Intensity Laser Therapy

Subacromial Impingement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971215
• Other study ID #: jagHNSP
• Status: Completed
• Phase: N/A
• First received: November 15, 2016
• Last updated: November 6, 2017
• Start date: November 2016
• Est. completion date: July 2017

Study information

• Verified date: March 2017
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Subacromial Impingement

Intervention

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 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.

Locations

Country	Name	City	State
Spain	Hospital General Nuestra Señora del Prado	Talavera de la Reina	Toledo

Sponsors (3)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Castilla-La Mancha Health Service, Hospital General Nuestra Señora del Prado

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	EQ-5D™ is a standardised instrument for use as a measure of health outcome.	Baseline
Primary	Shoulder Pain and Disability Index (SPADI)	SPADI test	Baseline
Primary	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-)
Primary	Shoulder Pain and Disability Index (SPADI)	SPADI test	one month after the end of the protocol treatment
Primary	Shoulder Pain and Disability Index (SPADI)	SPADI test	three months after the end of the protocol treatment
Primary	Constant-Murley Score	Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.	Baseline
Primary	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-)
Primary	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
Primary	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
Primary	Quick-Dash Abbreviated	Quick- Dash Abbreviated test	Baseline
Primary	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-)
Primary	Quick-Dash Abbreviated	Quick- Dash Abbreviated test	one month after the end of the protocol treatment
Primary	Quick-Dash Abbreviated	Quick- Dash Abbreviated test	three months after the end of the protocol treatment
Secondary	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
Secondary	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.
Secondary	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