Knee ArthropathyNCT04183673
Laser + Cryo-thermal Therapy Following Total Knee Replacement Surgery
A study testing Laser therapy-cryo thermal therapy in people with Knee Arthropathy, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
Objective To investigate the effectiveness of the use of the QMD Helios Laser device in association with standard rehabilitation therapy in reducing inflammatory symptoms in patients following total knee replacement. Design Randomized controlled trial. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- Laser therapy-cryo thermal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- 29 May 2018to 28 Feb 2019
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- good general physical conditions
- first total knee replacement
Who cannot join
- diabetic neuropathy
- renal or hearth disease
- allergic reactions
- Reynaud's disease
- lupus
- rheumatoids arthritis
- peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
Italy1 site
ICS Maugeri, Montescano Rehabilitation Center
Montescano, Pavia, 27040
About this study
Official title: Efficacy of Laser + Cryo-thermal Therapy in Rehabilitation Following Total Knee Replacement Surgery: a Randomized Controlled Trial
Objective To investigate the effectiveness of the use of the QMD Helios Laser device in association with standard rehabilitation therapy in reducing inflammatory symptoms in patients following total knee replacement.
Design Randomized controlled trial. Setting Rehabilitation structure, inpatient Main outcome measures Pain subscale of the WOMAC and Lequesne's Algo-Functional Index (LIKERT scale), knee circumference (measured at the middle line of the knee joint space) and knee flexion /extension range of motion by goniometer.
Read the detailed description
As life expectancy increases, more and more people are afflicted with degenerative joint diseases. Knee osteoarthritis is a pathology typical of old age (over 60 years), but it can also occur in younger people (aged 40-50 years) and is more prevalent in women (11%) than men (7%). Total knee replacement surgery is becoming increasingly frequent.In the immediate post-operative period, the main problems encountered by patients are: inflammation, edema and, above all, pain. These can strongly influence the restoring of a correct muscle-joint function and hence the time needed for a return to normal activities of daily living (ADLs).Post-operative rehabilitation is now a fundamental part of the functional recovery of patients after knee replacement surgery. Traditional rehabilitation programs are mainly focused on improving joint mobility, reducing musculotendinous retractions, increasing muscle strength and establishing a correct gait pattern. Over the years, in addition to the manual rehabilitative techniques, the use of instrumental methods to stimulate the healing processes and speed up recovery times has become a frequent practice, especially for the management of post-operative pain and inflammation. One of these methods is laser therapy, which consists of light radiation composed of a beam of photons with specific physical characteristics that interacts with living tissue to produce an anti-inflammatory, analgesic and biostimulation effect. Another form of instrumental therapy used in rehabilitation for the management of pain/edema resulting from an inflammatory process is the application of cold (cryotherapy) or heat (thermotherapy) or both together in combination (contrast therapy). Cryotherapy is a type of physical therapy that produces temporary anesthesia of the part undergoing treatment.Thermotherapy consists of the application of heat to stimulate a biological process inducing the release of chemotactic substances and growth factors, which have a powerful regenerative and reparative action. An innovative device that combines the therapeutic advantages of these different forms of physical therapy is QMD Helios (Hakomed, Egna, BZ, Italy), designed to provide cryo-thermal and laser treatment. The device is equipped with a high-power diode laser. This therapeutic laser can work at 3 different wavelengths (808 nm,1064 nm, 1120 nm). The wavelengths are each individually controlled and can be delivered in various modes: continuous wave, pulsed mode, super pulse, and Harmonic pulsation (laser wave emission with a variable frequency - determined by means of a scan performed by the device - suited to the tissue to be treated). This innovative triple-wavelength emission represents the most versatile solution when one wishes to obtain different therapeutic effects at the same time. In addition to the use of laser, the device allows the application of cryo-thermal therapy, simultaneously or separately. Simultaneous administration promotes thermal shock, a basic principle of contrast therapy characterized by a marked variation of temperature (30-40 degrees) within a short space of time (30-60 seconds) inducing vasodilation through the heat and vasoconstriction through the cold. Thermal shock is effective in the early stages of rehabilitation for a rapid resolution of pain and swelling.Although in recent years instrumental therapy has come to play a very important role in rehabilitation medicine in the management of pain/inflammation in the acute patient, there is lack of reported evidence in the literature on the use of laser therapy in patients after knee replacement surgery. The aim of this study is to evaluate the effectiveness of the use of the QMD Helios laser device in association with standard rehabilitation therapy in reducing edema and pain symptoms in patients following total knee replacement.
- Conditions
- Knee Arthropathy
- Being tested
- Laser therapy-cryo thermal therapy, Usual care
- Keywords
- Laser Therapy, Cryotherapy, Thermotherapy, Rehabilitation, knee replacement
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser therapy-cryo thermal therapyProcedure or surgery
5 days per week, 3 weeks, sessions including laser therapy + cryo therapy followed by usual rehabilitation
Usual careProcedure or surgery
5 days per week, 3 weeks, sessions of usual rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Laser-cryo-usual care | Experimental | Sessions 5 days a week for 3 weeks. Each session includes laser therapy+ cryo-thermal followed by standard rehabilitation program Receives: Procedure: Laser therapy-cryo thermal therapy |
| usual care | Active comparator | Sessions 5 days a week for 3 weeks. Each session includes only standard rehabilitation program Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Womac Pain subscale
Pain subscale of the Western Ontario and McMaster Universities Activity Index (scored on a five point (0-4) LIKERT scale)
Measured: Before treatment (admission) and after treatment (3 weeks after admission)
Change in knee circumference
Knee circumference measured at the middle line of the knee joint space
Measured: Before treatment (admission) and after treatment (3 weeks after admission)
Change in Lequesne's algo Functional Index
Lequesne's algo Functional Index (scored on a five point (0-4) LIKERT scale)
Measured: Before treatment (admission) and after treatment (3 weeks after admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start29 May 2018
- Primary completion31 Jan 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183673
- Sponsor's protocol ID
- 2200 CE
- Status last verified
- Mar 2022
- First submitted
- 19 Nov 2019
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Laser + Cryo-thermal Therapy in Rehabilitation Following Total Knee Replacement Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04183673
- Acronym / sponsor ID
- 2200 CE
- Conditions
- Knee Arthropathy
- Keywords
- Laser Therapy, Cryotherapy, Thermotherapy, Rehabilitation, knee replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 3 Dec 2019 (actual)
- 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.
Objective To investigate the effectiveness of the use of the QMD Helios Laser device in association with standard rehabilitation therapy in reducing inflammatory symptoms in patients following total knee replacement.
Design Randomized controlled trial. Setting Rehabilitation structure, inpatient Main outcome measures Pain subscale of the WOMAC and Lequesne's Algo-Functional Index (LIKERT scale), knee circumference (measured at the middle line of the knee joint space) and knee flexion /extension range of motion by goniometer.
Detailed description
As life expectancy increases, more and more people are afflicted with degenerative joint diseases. Knee osteoarthritis is a pathology typical of old age (over 60 years), but it can also occur in younger people (aged 40-50 years) and is more prevalent in women (11%) than men (7%). Total knee replacement surgery is becoming increasingly frequent.In the immediate post-operative period, the main problems encountered by patients are: inflammation, edema and, above all, pain. These can strongly influence the restoring of a correct muscle-joint function and hence the time needed for a return to normal activities of daily living (ADLs).Post-operative rehabilitation is now a fundamental part of the functional recovery of patients after knee replacement surgery. Traditional rehabilitation programs are mainly focused on improving joint mobility, reducing musculotendinous retractions, increasing muscle strength and establishing a correct gait pattern. Over the years, in addition to the manual rehabilitative techniques, the use of instrumental methods to stimulate the healing processes and speed up recovery times has become a frequent practice, especially for the management of post-operative pain and inflammation. One of these methods is laser therapy, which consists of light radiation composed of a beam of photons with specific physical characteristics that interacts with living tissue to produce an anti-inflammatory, analgesic and biostimulation effect. Another form of instrumental therapy used in rehabilitation for the management of pain/edema resulting from an inflammatory process is the application of cold (cryotherapy) or heat (thermotherapy) or both together in combination (contrast therapy). Cryotherapy is a type of physical therapy that produces temporary anesthesia of the part undergoing treatment.Thermotherapy consists of the application of heat to stimulate a biological process inducing the release of chemotactic substances and growth factors, which have a powerful regenerative and reparative action. An innovative device that combines the therapeutic advantages of these different forms of physical therapy is QMD Helios (Hakomed, Egna, BZ, Italy), designed to provide cryo-thermal and laser treatment. The device is equipped with a high-power diode laser. This therapeutic laser can work at 3 different wavelengths (808 nm,1064 nm, 1120 nm). The wavelengths are each individually controlled and can be delivered in various modes: continuous wave, pulsed mode, super pulse, and Harmonic pulsation (laser wave emission with a variable frequency - determined by means of a scan performed by the device - suited to the tissue to be treated). This innovative triple-wavelength emission represents the most versatile solution when one wishes to obtain different therapeutic effects at the same time. In addition to the use of laser, the device allows the application of cryo-thermal therapy, simultaneously or separately. Simultaneous administration promotes thermal shock, a basic principle of contrast therapy characterized by a marked variation of temperature (30-40 degrees) within a short space of time (30-60 seconds) inducing vasodilation through the heat and vasoconstriction through the cold. Thermal shock is effective in the early stages of rehabilitation for a rapid resolution of pain and swelling.Although in recent years instrumental therapy has come to play a very important role in rehabilitation medicine in the management of pain/inflammation in the acute patient, there is lack of reported evidence in the literature on the use of laser therapy in patients after knee replacement surgery. The aim of this study is to evaluate the effectiveness of the use of the QMD Helios laser device in association with standard rehabilitation therapy in reducing edema and pain symptoms in patients following total knee replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser-cryo-usual care | Experimental | Procedure: Laser therapy-cryo thermal therapySessions 5 days a week for 3 weeks. Each session includes laser therapy+ cryo-thermal followed by standard rehabilitation program |
| usual care | Active comparator | Procedure: Usual careSessions 5 days a week for 3 weeks. Each session includes only standard rehabilitation program |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- good general physical conditions
- first total knee replacement
Key exclusion criteria (7 listed)
- diabetic neuropathy
- renal or hearth disease
- allergic reactions
- Reynaud's disease
- lupus
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 |
|---|---|---|
| Laser therapy-cryo thermal therapy5 days per week, 3 weeks, sessions including laser therapy + cryo therapy followed by usual rehabilitation | Procedure or surgery | Laser-cryo-usual care |
| Usual care5 days per week, 3 weeks, sessions of usual rehabilitation | Procedure or surgery | usual care |
Primary outcome
Change in Womac Pain subscale
Time frame: Before treatment (admission) and after treatment (3 weeks after admission)
Pain subscale of the Western Ontario and McMaster Universities Activity Index (scored on a five point (0-4) LIKERT scale)
Change in knee circumference
Time frame: Before treatment (admission) and after treatment (3 weeks after admission)
Knee circumference measured at the middle line of the knee joint space
Change in Lequesne's algo Functional Index
Time frame: Before treatment (admission) and after treatment (3 weeks after admission)
Lequesne's algo Functional Index (scored on a five point (0-4) LIKERT scale)
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 1 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Knee Arthropathy
RecruitingObservational study
MRI Study of Musculoskeletal Function
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A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
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 Laser therapy-cryo thermal therapy in people with Knee Arthropathy, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 7 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 1 Apr 2022. 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 Italy. 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.
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?
Change in Womac Pain subscale (time frame: Before treatment (admission) and after treatment (3 weeks after admission)). The study lists 3 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 1 Apr 2022.