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Subacromial Impingement Syndrome Approach Using High Intensity Laser Therapy

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

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.

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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

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.




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971215


Locations
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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
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Principal Investigator: Javier Aceituno-Gomez, PT Castilla-La Mancha Health Service
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Responsible Party: University of Castilla-La Mancha
ClinicalTrials.gov Identifier: NCT02971215    
Other Study ID Numbers: jagHNSP
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases
Shoulder Injuries
Wounds and Injuries