Clinical trial NCT02971215: Subacromial Impingement Syndrome Approach Using High Intensity Laser Therapy
Official title: Effectiveness of High Intensity Laser Therapy in the Treatment of Subacromial Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Castilla-La Mancha Health Service
name: Hospital General Nuestra Señora del Prado
First posted: 2016-11-22
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Baseline
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-)
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: one month after the end of the protocol treatment
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: three months after the end of the protocol treatment
measure: Constant-Murley Score
timeFrame: Baseline
measure: Constant-Murley Score
timeFrame: At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-)
measure: Constant-Murley Score
timeFrame: one month after the end of the protocol treatment
measure: Constant-Murley Score
timeFrame: three months after the end of the protocol treatment
measure: Quick-Dash Abbreviated
timeFrame: Baseline
measure: Quick-Dash Abbreviated
timeFrame: At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-)
measure: Quick-Dash Abbreviated
timeFrame: one month after the end of the protocol treatment
measure: Quick-Dash Abbreviated
timeFrame: three months after the end of the protocol treatment
Secondary outcomes:
measure: Painful pressure threshold
timeFrame: 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
measure: Painful pressure threshold after first session
timeFrame: First session - 15 minutes after laser or sham treatment.
measure: VAS
timeFrame: 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 outcomes:
measure: Quality of life
timeFrame: Baseline
Locations:
city: Talavera de la Reina
country: Spain
facility: Hospital General Nuestra Señora del Prado
state: Toledo
Study officials:
affiliation: Castilla-La Mancha Health Service
name: Javier Aceituno-Gomez, PT
role: PRINCIPAL_INVESTIGATOR
References: