Subacromial Impingement Syndrome Approach Using High Intensity Laser Therapy

• ClinicalTrials.gov Identifier: NCT02971215
• Recruitment Status: Completed
• First Posted: November 22, 2016
• Last Update Posted: November 8, 2017
• Sponsor: University of Castilla-La Mancha
• Collaborators: Castilla-La Mancha Health Service; Hospital General Nuestra Señora del Prado
• Information provided by (Responsible Party): University of Castilla-La Mancha

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Subacromial Impingement	Device: iLux Laser; Device: Sham ilux Laser	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of High Intensity Laser Therapy in the Treatment of Subacromial Impingement Syndrome
• Study Start Date: November 2016
• Actual Primary Completion Date: July 2017
• Actual Study Completion Date: July 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Shoulder Pain and Disability Index (SPADI) [ Time Frame: Baseline ]
   SPADI test
2. Shoulder Pain and Disability Index (SPADI) [ Time Frame: At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-) ]
   SPADI test
3. Shoulder Pain and Disability Index (SPADI) [ Time Frame: one month after the end of the protocol treatment ]
   SPADI test
4. Shoulder Pain and Disability Index (SPADI) [ Time Frame: three months after the end of the protocol treatment ]
   SPADI test
5. Constant-Murley Score [ Time Frame: Baseline ]
   Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
6. Constant-Murley Score [ Time Frame: At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-) ]
   Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
7. Constant-Murley Score [ Time Frame: one month after the end of the protocol treatment ]
   Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
8. Constant-Murley Score [ Time Frame: three months after the end of the protocol treatment ]
   Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
9. Quick-Dash Abbreviated [ Time Frame: Baseline ]
   Quick- Dash Abbreviated test
10. Quick-Dash Abbreviated [ Time Frame: At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-) ]
    Quick- Dash Abbreviated test
11. Quick-Dash Abbreviated [ Time Frame: one month after the end of the protocol treatment ]
    Quick- Dash Abbreviated test
12. Quick-Dash Abbreviated [ Time Frame: three months after the end of the protocol treatment ]
    Quick- Dash Abbreviated test

Secondary Outcome Measures :

1. Painful pressure threshold [ Time Frame: 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 ]
   The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.
2. Painful pressure threshold after first session [ Time Frame: First session - 15 minutes after laser or sham treatment. ]
   The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.
3. VAS [ Time Frame: 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 ]
   Visual analogue scale

Other Outcome Measures:

1. Quality of life [ Time Frame: Baseline ]
   EQ-5D™ is a standardised instrument for use as a measure of health outcome.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Spain

Hospital General Nuestra Señora del Prado

Talavera de la Reina, Toledo, Spain, 45600

Sponsors and Collaborators

University of Castilla-La Mancha

Castilla-La Mancha Health Service

Hospital General Nuestra Señora del Prado

Investigators

• Principal Investigator: Javier Aceituno-Gomez, PT; Castilla-La Mancha Health Service

More Information

• Responsible Party: University of Castilla-La Mancha
• ClinicalTrials.gov Identifier: NCT02971215
• Other Study ID Numbers: jagHNSP
• First Posted: November 22, 2016
• Last Update Posted: November 8, 2017
• Last Verified: March 2017

Additional relevant MeSH terms:

Shoulder Impingement Syndrome; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries