Subacromial ImpingementNCT02971215
Subacromial Impingement Syndrome Approach Using High Intensity Laser Therapy
A study testing iLux Laser in people with Subacromial Impingement, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
The purpose of this study is to assess the effectiveness of high intensity laser therapy in the treatment of subacromial impingement syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subacromial Impingement
- What is being tested?
- iLux Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital General Nuestra Señora del Prado
Talavera de la Reina, Toledo, 45600
About this study
Official title: Effectiveness of High Intensity Laser Therapy in the Treatment of Subacromial Impingement Syndrome
The purpose of this study is to assess the effectiveness of high intensity laser therapy in the treatment of subacromial impingement syndrome.
Read the 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.
- Conditions
- Subacromial Impingement
- Being tested
- iLux Laser, Sham ilux Laser
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iLux LaserDevice
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 LaserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity laser therapy | Experimental | High-intensity laser therapy application through iLux Laser device Receives: Device: iLux Laser |
| Sham device | Sham comparator | Sham high-intensity laser therapy application through sham iLux Laser device Receives: Device: Sham ilux Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index (SPADI)
SPADI test
Measured: Baseline
Shoulder Pain and Disability Index (SPADI)
SPADI test
Measured: 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
Measured: one month after the end of the protocol treatment
Shoulder Pain and Disability Index (SPADI)
SPADI test
Measured: 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.
Measured: Baseline
Constant-Murley Score
Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
Measured: 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.
Measured: 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.
Measured: three months after the end of the protocol treatment
Quick-Dash Abbreviated
Quick- Dash Abbreviated test
Measured: Baseline
Quick-Dash Abbreviated
Quick- Dash Abbreviated test
Measured: 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
Measured: one month after the end of the protocol treatment
Quick-Dash Abbreviated
Quick- Dash Abbreviated test
Measured: three months after the end of the protocol treatment
Secondary outcomes (3)
Painful pressure threshold
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.
Measured: 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
The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.
Measured: First session - 15 minutes after laser or sham treatment.
VAS
Visual analogue scale
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Castilla-La Mancha Health Service, Hospital General Nuestra Señora del Prado
- Responsible party
- Sponsor
- Investigators
- Javier Aceituno-Gomez, PT, Principal investigator, Castilla-La Mancha Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971215
- Sponsor's protocol ID
- jagHNSP
- Status last verified
- Mar 2017
- First submitted
- 15 Nov 2016
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High Intensity Laser Therapy in the Treatment of Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT02971215
- Acronym / sponsor ID
- jagHNSP
- Conditions
- Subacromial Impingement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Castilla-La Mancha Health Service, Hospital General Nuestra Señora del Prado
- Study start
- Nov 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity laser therapy | Experimental | Device: iLux LaserHigh-intensity laser therapy application through iLux Laser device |
| Sham device | Sham comparator | Device: Sham ilux LaserSham high-intensity laser therapy application through sham iLux Laser device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iLux LaserTreatment 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. | Device | High-intensity laser therapy |
| Sham ilux LaserSham 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. | Device | Sham device |
Primary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline
SPADI test
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
Shoulder Pain and Disability Index (SPADI)
Time frame: one month after the end of the protocol treatment
SPADI test
Shoulder Pain and Disability Index (SPADI)
Time frame: three months after the end of the protocol treatment
SPADI test
Constant-Murley Score
Time frame: Baseline
Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.
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.
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.
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.
Quick-Dash Abbreviated
Time frame: Baseline
Quick- Dash Abbreviated test
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
Quick-Dash Abbreviated
Time frame: one month after the end of the protocol treatment
Quick- Dash Abbreviated test
Quick-Dash Abbreviated
Time frame: three months after the end of the protocol treatment
Quick- Dash Abbreviated test
3 secondary outcomes
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
Painful pressure threshold after first session
Time frame: First session - 15 minutes after laser or sham treatment.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
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Natural History of Shoulder Pathology in Manual Wheelchair Users
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Aceituno-Gomez, PT principal investigator
Castilla-La Mancha Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iLux Laser in people with Subacromial Impingement, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain and Disability Index (SPADI) (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.