Subacromial Impingement Syndrome Approach Using High Intensity Laser Therapy

NCT02971215 | Completed

• 1 other identifier: jagHNSP
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Subacromial Impingement

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (3)

• Painful pressure threshold

  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

  First session - 15 minutes after laser or sham treatment.

• VAS

  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 (1)

• Quality of life

  Baseline

Study Arms (2)

High-intensity laser therapy

EXPERIMENTAL

High-intensity laser therapy application through iLux Laser device

Device: iLux Laser

Sham device

SHAM COMPARATOR

Sham high-intensity laser therapy application through sham iLux Laser device

Device: Sham ilux Laser

Interventions

iLux Laser DEVICE

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.

High-intensity laser therapy

Sham ilux Laser DEVICE

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.

Sham device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Castilla-La Mancha Health Service: collaborator
• Hospital General Nuestra Señora del Prado: collaborator

Study Sites (1)

Hospital General Nuestra Señora del Prado

Talavera de la Reina, Toledo, 45600, Spain

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Javier Aceituno-Gomez, PT

  Castilla-La Mancha Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 22, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-03

Locations

ES (1)