Arthroplasty, Replacement, HipNCT02970890
Effects of Photobiomodulation Therapy (PBMT) in Total Hip Arthroplasty
A study testing Portable Pain Away™ in people with Arthroplasty, Replacement, Hip, run by Adriane Aver Vanin at 1 site in Brazil.
Trial summary
Osteoarthritis (OA), a chronic degenerative muscle disease characterized by cartilage wear, causes progressive joint deformity and loss of function leading to the indication of total hip arthroplasty (THA), when conservative treatments fail. Surgical trauma leads to pain and induces an immune response. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- Portable Pain Away™
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2016to Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men and women with clinical diagnosis of OA based on radiological images in the anteroposterior and profile according to Demur classification.
Who cannot join
- Men and women with other clinical diagnosis
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Beneficência Nossa Senhora do Pari
São Paulo, São Paulo, 03031-040
About this study
Official title: Effects of Photobiomodulation Therapy (PBMT) on Acute Pain and Inflammation in Patients Who Underwent Total Hip Arthroplasty
Osteoarthritis (OA), a chronic degenerative muscle disease characterized by cartilage wear, causes progressive joint deformity and loss of function leading to the indication of total hip arthroplasty (THA), when conservative treatments fail. Surgical trauma leads to pain and induces an immune response. Photobiomodulation therapy (PBMT) has proven effective in tissue repair by modulating the inflammatory process and promoting pain relief. It can therefore be part of the treatment. This study aims to analyze the effect of PMBT on inflammation and pain of patients who underwent total hip arthroplasty. The study consisted of eighteen patients who underwent hip arthroplasty and they received phototherapy in a period from 8 to 12 hours after surgery. We divided the patients into two groups (n=9 each) placebo and effective phototherapy. The patients were evaluated before and after phototherapy with 9 diodes, applied to 5 points along the scar (1 laser 905nm, 4 LEDs 875nm and 4 LEDs 640nm, 40.3J total), by visual analogue scale (VAS) and blood collection for analysis of the levels of the cytokines TNF-α, IL-6 and IL-8.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- Portable Pain Away™
- Keywords
- Total Hip Arthroplasty (THA), Phototherapy, Low-level laser therapy, Light-emitting diodes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable Pain Away™Device
Also called Photobiomodulation therapy (PBMT)
Portable Pain Away™ device (manufactured by Multi Radiance Medical, Solon - OH, USA) - placebo or active phototherapy
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Subjects received placebo therapy. The placebo Portable Pain Away™ device was identical to the active device, displayed the same settings and emitted the same sound regardless of the comparator. Receives: Device: Portable Pain Away™ |
| PBMT group | Active comparator | Subjects received active photobiomodulation therapy (PBMT). The active Portable Pain Away™ device was identical to the placebo device, displayed the same settings and emitted the same sound. Receives: Device: Portable Pain Away™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Pain (VAS)
A visual analogue scale (VAS) of 100 mm was used for the self-rating of the patients pain intensity, with assistance of a blinded researcher. Pain assessments were performed at baseline, immediately after phototherapy irradiation.
Measured: Change from baseline in VAS to immediately after phototherapy
Evaluation of Cytokines levels (ELISA immunoenzymatic assay)
Cytokine levels (IL-6, IL-8 and TNF-α) in blood samples collected from patients before and after irradiation of phototherapy were evaluated using the Duo Set kit (BD Biosciences) according to the manufacturer's instructions.
Measured: Change from baseline in Cytokines levels to immediately after phototherapy
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 startJul 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adriane Aver Vanin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adriane Aver Vanin, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970890
- Sponsor's protocol ID
- 066490
- Status last verified
- Apr 2017
- First submitted
- 1 Nov 2016
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation Therapy (PBMT) on Acute Pain and Inflammation in Patients Who Underwent Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02970890
- Acronym / sponsor ID
- 066490
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Total Hip Arthroplasty (THA), Phototherapy, Low-level laser therapy, Light-emitting diodes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Adriane Aver VaninUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 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.
Osteoarthritis (OA), a chronic degenerative muscle disease characterized by cartilage wear, causes progressive joint deformity and loss of function leading to the indication of total hip arthroplasty (THA), when conservative treatments fail. Surgical trauma leads to pain and induces an immune response. Photobiomodulation therapy (PBMT) has proven effective in tissue repair by modulating the inflammatory process and promoting pain relief. It can therefore be part of the treatment. This study aims to analyze the effect of PMBT on inflammation and pain of patients who underwent total hip arthroplasty. The study consisted of eighteen patients who underwent hip arthroplasty and they received phototherapy in a period from 8 to 12 hours after surgery. We divided the patients into two groups (n=9 each) placebo and effective phototherapy. The patients were evaluated before and after phototherapy with 9 diodes, applied to 5 points along the scar (1 laser 905nm, 4 LEDs 875nm and 4 LEDs 640nm, 40.3J total), by visual analogue scale (VAS) and blood collection for analysis of the levels of the cytokines TNF-α, IL-6 and IL-8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Device: Portable Pain Away™Subjects received placebo therapy. The placebo Portable Pain Away™ device was identical to the active device, displayed the same settings and emitted the same sound regardless of the comparator. |
| PBMT group | Active comparator | Device: Portable Pain Away™Subjects received active photobiomodulation therapy (PBMT). The active Portable Pain Away™ device was identical to the placebo device, displayed the same settings and emitted the same sound. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women with clinical diagnosis of OA based on radiological images in the anteroposterior and profile according to Demur classification.
Key exclusion criteria (1 listed)
- Men and women with other clinical diagnosis
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 |
|---|---|---|
| Portable Pain Away™Also: Photobiomodulation therapy (PBMT)Portable Pain Away™ device (manufactured by Multi Radiance Medical, Solon - OH, USA) - placebo or active phototherapy | Device | PBMT group, Placebo group |
Primary outcome
Evaluation of Pain (VAS)
Time frame: Change from baseline in VAS to immediately after phototherapy
A visual analogue scale (VAS) of 100 mm was used for the self-rating of the patients pain intensity, with assistance of a blinded researcher. Pain assessments were performed at baseline, immediately after phototherapy irradiation.
Evaluation of Cytokines levels (ELISA immunoenzymatic assay)
Time frame: Change from baseline in Cytokines levels to immediately after phototherapy
Cytokine levels (IL-6, IL-8 and TNF-α) in blood samples collected from patients before and after irradiation of phototherapy were evaluated using the Duo Set kit (BD Biosciences) according to the manufacturer's instructions.
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 20 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable Pain Away™ in people with Arthroplasty, Replacement, Hip, run by Adriane Aver Vanin at 1 site in Brazil.
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 1 inclusion and 1 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 20 Apr 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 Brazil. 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?
Evaluation of Pain (VAS) (time frame: Change from baseline in VAS to immediately after phototherapy). The study lists 2 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 20 Apr 2017.