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Completed

NCT Number: NCT02971215

Subacromial Impingement Syndrome Approach Using High Intensity Laser Therapy

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Nuestra Señora del Prado

Talavera de la Reina, Toledo, 45600, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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 outcomes

  1. Quality of life

    Time frame: Baseline

    EQ-5D™ is a standardised instrument for use as a measure of health outcome.

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Collaborators

  • Castilla-La Mancha Health Service
  • Hospital General Nuestra Señora del Prado

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 22, 2016
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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