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Subacromial Impingement Syndrome Approach Using High Intensity Laser Therapy

Primary Purpose

Subacromial Impingement

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
iLux Laser
Sham ilux Laser
Sponsored by
University of Castilla-La Mancha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital General Nuestra Señora del Prado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

High-intensity laser therapy

Sham device

Arm Description

High-intensity laser therapy application through iLux Laser device

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

Outcomes

Primary Outcome Measures

Shoulder Pain and Disability Index (SPADI)
SPADI test
Shoulder Pain and Disability Index (SPADI)
SPADI test
Shoulder Pain and Disability Index (SPADI)
SPADI test
Shoulder Pain and Disability Index (SPADI)
SPADI test
Constant-Murley Score
Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
Constant-Murley Score
Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
Constant-Murley Score
Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
Constant-Murley Score
Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
Quick-Dash Abbreviated
Quick- Dash Abbreviated test
Quick-Dash Abbreviated
Quick- Dash Abbreviated test
Quick-Dash Abbreviated
Quick- Dash Abbreviated test
Quick-Dash Abbreviated
Quick- Dash Abbreviated test

Secondary Outcome Measures

Painful pressure threshold
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.
Painful pressure threshold after first session
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.
VAS
Visual analogue scale

Full Information

First Posted
November 15, 2016
Last Updated
November 6, 2017
Sponsor
University of Castilla-La Mancha
Collaborators
Castilla-La Mancha Health Service, Hospital General Nuestra Señora del Prado
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1. Study Identification

Unique Protocol Identification Number
NCT02971215
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Castilla-La Mancha
Collaborators
Castilla-La Mancha Health Service, Hospital General Nuestra Señora del Prado

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity laser therapy
Arm Type
Experimental
Arm Description
High-intensity laser therapy application through iLux Laser device
Arm Title
Sham device
Arm Type
Sham Comparator
Arm Description
Sham high-intensity laser therapy application through sham iLux Laser device
Intervention Type
Device
Intervention Name(s)
iLux Laser
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham ilux Laser
Intervention Description
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 Measure Information:
Title
Shoulder Pain and Disability Index (SPADI)
Description
SPADI test
Time Frame
Baseline
Title
Shoulder Pain and Disability Index (SPADI)
Description
SPADI test
Time Frame
At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-)
Title
Shoulder Pain and Disability Index (SPADI)
Description
SPADI test
Time Frame
one month after the end of the protocol treatment
Title
Shoulder Pain and Disability Index (SPADI)
Description
SPADI test
Time Frame
three months after the end of the protocol treatment
Title
Constant-Murley Score
Description
Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
Time Frame
Baseline
Title
Constant-Murley Score
Description
Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
Time Frame
At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-)
Title
Constant-Murley Score
Description
Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
Time Frame
one month after the end of the protocol treatment
Title
Constant-Murley Score
Description
Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
Time Frame
three months after the end of the protocol treatment
Title
Quick-Dash Abbreviated
Description
Quick- Dash Abbreviated test
Time Frame
Baseline
Title
Quick-Dash Abbreviated
Description
Quick- Dash Abbreviated test
Time Frame
At the end of the laser protocol treatment (1 daily session during 15 workday -from monday to friday-)
Title
Quick-Dash Abbreviated
Description
Quick- Dash Abbreviated test
Time Frame
one month after the end of the protocol treatment
Title
Quick-Dash Abbreviated
Description
Quick- Dash Abbreviated test
Time Frame
three months after the end of the protocol treatment
Secondary Outcome Measure Information:
Title
Painful pressure threshold
Description
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.
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
Title
Painful pressure threshold after first session
Description
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.
Time Frame
First session - 15 minutes after laser or sham treatment.
Title
VAS
Description
Visual analogue scale
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
Other Pre-specified Outcome Measures:
Title
Quality of life
Description
EQ-5D™ is a standardised instrument for use as a measure of health outcome.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Aceituno-Gomez, PT
Organizational Affiliation
Castilla-La Mancha Health Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Nuestra Señora del Prado
City
Talavera de la Reina
State/Province
Toledo
ZIP/Postal Code
45600
Country
Spain

12. IPD Sharing Statement

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Subacromial Impingement Syndrome Approach Using High Intensity Laser Therapy

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