Shoulder Musculoskeletal DisordersPhase 2PI070046NCT00694538
Efficacy of Interferential Laser Therapy in Shoulder Pain
A Phase 2 study testing Interferential Laser therapy in people with Shoulder Musculoskeletal Disorders, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
The purpose of this study is to determine the advantages of the interferential laser therapy in shoulder pain reduction compared with the conventional low level laser therapy modality. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Shoulder Musculoskeletal Disorders
- What is being tested?
- Interferential Laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2008to Nov 2009
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute or chronic pain from musculoskeletal origin
- Age between 18 and 70 years
Who cannot join
- Brachial plexus palsy
- Neurological diseases
- Pacemakers
- Shoulder pain from cervical pathology
- Osteosynthesis material
- Fibromyalgia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Interferential Laser Therapy in Pain Reduction in Shoulder Musculoskeletal Pathologies.
The purpose of this study is to determine the advantages of the interferential laser therapy in shoulder pain reduction compared with the conventional low level laser therapy modality.
Read the detailed description
The spatiotemporal superposition of two independent and opposite beams of laser generates a constructive interference pattern that increases the therapeutic effects in the irradiated tissue. Patients diagnosed of shoulder pain from different musculoskeletal disorders will received conventional or interferential laser therapy. This is a comparative, randomized and double - blind clinical study. Two identical equipments of near infrared laser therapy will be used. Number of sessions: 15. Frequency of the sessions: daily. Irradiation technique: manual, contact and punctual.Pain will be evaluated by visual analog scale (VAS) at rest and during analytical shoulder movements (abduction, adduction, internal rotation, external rotation, flexion, extension) and by means of a pain and disability index (SPADI). Evaluations will take place at pre and post treatment.
- Conditions
- Shoulder Musculoskeletal Disorders
- Being tested
- Interferential Laser therapy
- Keywords
- Interferential laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferential Laser therapyDevice
Also called Interference Laser Therapy., Device Brand Name: Laser Sys. Stim 540(Mettler Electronics)., SN: 105XLS147 (first laser) and 105XLS148 (second laser).
Two GaAlAs laser (810 nm, 100mW)were used. In the interferential laser treatment, two probes were simultaneously applied. In the conventional laser group, only one probe was switched on. Laser was applied at five points over the pain area. The laser emission mode was continuous with an energy dose of 6 joules per point and session, a power density of 1.09 w/cm2 and an irradiation time per point of 60 s. The average output power was 100 mW and the total energy dose delivered in a patient session was 30 J. Every treatment was along 15 sessions. Hence, the accumulated energy delivered on the whole was 450 Joules for the conventional group of patients (using one beam) and 900 Joules for the interferential one (using two beams).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 100 patients are being treated with a single laser beam over pain area. Receives: Device: Interferential Laser therapy |
| 2 | Experimental | 100 patients are being treated with interferential laser from two independent sources Receives: Device: Interferential Laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain will be evaluated by visual analog scale (VAS) at rest and during analytical shoulder movements.
Measured: Five minutes
Secondary outcomes (1)
Shoulder Pain Disability Index (SPADI)
Measured: ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder Musculoskeletal DisordersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Investigators
- Ramon Montes-Molina, PT, Principal investigator, Hospital Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694538
- Sponsor's protocol ID
- PI070046
- Other IDs
- PI 070046
- Acronym
- PI070046
- Status last verified
- Nov 2009
- First submitted
- 29 May 2008
- Last updated
- 13 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Montes-Molina R, Madronero-Agreda MA, Romojaro-Rodriguez AB, Gallego-Mendez V, Prados-Cabiedas C, Marques-Lucas C, Perez-Ferreiro M, Martinez-Ruiz F. Efficacy of interferential low-level laser therapy using two independent sources in the treatment of knee pain. Photomed Laser Surg. 2009 Jun;27(3):467-71. doi: 10.1089/pho.2008.2315.
PubMed 19405858Montes-Molina R, Prieto-Baquero A, Martinez-Rodriguez ME, Romojaro-Rodriguez AB, Gallego-Mendez V, Martinez-Ruiz F. Interferential laser therapy in the treatment of shoulder pain and disability from musculoskeletal pathologies: a randomised comparative study. Physiotherapy. 2012 Jun;98(2):143-50. doi: 10.1016/j.physio.2011.02.007. Epub 2011 May 28.
PubMed 22507365
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Interferential Laser Therapy in Pain Reduction in Shoulder Musculoskeletal Pathologies.
- ClinicalTrials.gov ID
- NCT00694538
- Acronym / sponsor ID
- PI070046 / PI070046
- Conditions
- Shoulder Musculoskeletal Disorders
- Keywords
- Interferential laser therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 10 Jun 2008 (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 determine the advantages of the interferential laser therapy in shoulder pain reduction compared with the conventional low level laser therapy modality.
Detailed description
The spatiotemporal superposition of two independent and opposite beams of laser generates a constructive interference pattern that increases the therapeutic effects in the irradiated tissue. Patients diagnosed of shoulder pain from different musculoskeletal disorders will received conventional or interferential laser therapy. This is a comparative, randomized and double - blind clinical study. Two identical equipments of near infrared laser therapy will be used. Number of sessions: 15. Frequency of the sessions: daily. Irradiation technique: manual, contact and punctual.Pain will be evaluated by visual analog scale (VAS) at rest and during analytical shoulder movements (abduction, adduction, internal rotation, external rotation, flexion, extension) and by means of a pain and disability index (SPADI). Evaluations will take place at pre and post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Interferential Laser therapy100 patients are being treated with a single laser beam over pain area. |
| 2 | Experimental | Device: Interferential Laser therapy100 patients are being treated with interferential laser from two independent sources |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute or chronic pain from musculoskeletal origin
- Age between 18 and 70 years
Key exclusion criteria (6 listed)
- Brachial plexus palsy
- Neurological diseases
- Pacemakers
- Shoulder pain from cervical pathology
- Osteosynthesis material
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 |
|---|---|---|
| Interferential Laser therapyAlso: Interference Laser Therapy., Device Brand Name: Laser Sys. Stim 540(Mettler Electronics)., SN: 105XLS147 (first laser) and 105XLS148 (second laser).Two GaAlAs laser (810 nm, 100mW)were used. In the interferential laser treatment, two probes were simultaneously applied. In the conventional laser group, only one probe was switched on. Laser was applied at five points over the pain area. The laser emission mode was continuous with an energy dose of 6 joules per point and session, a power density of 1.09 w/cm2 and an irradiation time per point of 60 s. The average output power was 100 mW and the total energy dose delivered in a patient session was 30 J. Every treatment was along 15 sessions. Hence, the accumulated energy delivered on the whole was 450 Joules for the conventional group of patients (using one beam) and 900 Joules for the interferential one (using two beams). | Device | 1, 2 |
Primary outcome
Pain will be evaluated by visual analog scale (VAS) at rest and during analytical shoulder movements.
Time frame: Five minutes
1 secondary outcome
Shoulder Pain Disability Index (SPADI)
Time frame: ten minutes
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 13 Nov 2009.
- Background: PubMed 19405858Montes-Molina R, Madronero-Agreda MA, Romojaro-Rodriguez AB, Gallego-Mendez V, Prados-Cabiedas C, Marques-Lucas C, Perez-Ferreiro M, Martinez-Ruiz F. Efficacy of interferential low-level laser therapy using two independent sources in the treatment of knee pain. Photomed Laser Surg. 2009 Jun;27(3):467-71. doi: 10.1089/pho.2008.2315.
- Derived from this study: PubMed 22507365Montes-Molina R, Prieto-Baquero A, Martinez-Rodriguez ME, Romojaro-Rodriguez AB, Gallego-Mendez V, Martinez-Ruiz F. Interferential laser therapy in the treatment of shoulder pain and disability from musculoskeletal pathologies: a randomised comparative study. Physiotherapy. 2012 Jun;98(2):143-50. doi: 10.1016/j.physio.2011.02.007. Epub 2011 May 28.
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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.
Ramon Montes-Molina, PT principal investigator
Hospital Ramon y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interferential Laser therapy in people with Shoulder Musculoskeletal Disorders, run by Hospital Universitario Ramon y Cajal 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 2 inclusion and 6 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 13 Nov 2009. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain will be evaluated by visual analog scale (VAS) at rest and during analytical shoulder movements. (time frame: Five minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00694538, which also lists 2 linked publications.
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 13 Nov 2009.