Total Knee ArthroplastyNCT03395444
Pulsed Shortwave Therapy Adjunct Pain and Recovery in Total Knee Replacement
A study testing pulsed shortwave therapy in people with Total Knee Arthroplasty, run by BioElectronics Corporation at 1 site in Lebanon.
Trial summary
This clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to the postoperative pain and recovery protocol following total knee replacement. Pulsed shortwave therapy is a safe adjunct pain therapy for acute and chronic pain. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- pulsed shortwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteLebanon
- Study dates
- 15 Dec 2017to 15 Mar 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for knee osteoarthritis;
- Planned spinal anesthesia; American Society of Anesthesiologists (ASA) physical status I-II;
- Scheduled for unilateral TKA;
- Patients aged 50 to 80 years old.
- Willingness to give written informed consent and willingness to participate in and comply with the study.
Who cannot join
- Unwillingness of the patient;
- Presence of neuropathic pain or sensory disorders in the leg to be operated on;
- Intolerance to the study drugs;
- Failure of spinal anesthesia;
- Previous major knee surgery, re-operation or trauma to the knee within the study period.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
New Mazloum Hospital
Tripoli
Mahmoud Masarani, Ph.D, 96179156547, M.masarani@outlook.fr
About this study
Official title: Double Blind Placebo-controlled Clinical Trial to Assess Pulsed Shortwave Therapy as an Adjunct Pain Therapy & Knee Recovery for Total Knee Arthroplasty
This clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to the postoperative pain and recovery protocol following total knee replacement. Pulsed shortwave therapy is a safe adjunct pain therapy for acute and chronic pain.
Read the detailed description
Despite the recent advances in the understanding of pain mechanisms and the introduction of new drugs and new techniques in the postoperative management, pain after total knee arthroplasty (TKA) is still an unresolved issue. It affects the quality of life and rehabilitation of an important percentage of patients undergoing TKA. A recent study looked at the percentage of patients with chronic knee pain after knee replacement at a minimum of one year following surgery in 272 patients, 107 patients (nearly 40%) reported that they still had persistent pain at one-plus year following surgery. Central sensitization is now well established as an integral factor in many chronic pain states, including the commonly occurring knee and back pain. Many patients undergoing TKA are likely to have a significant degree of Central Sensitization, therefore the likely hood of high pain levels postoperative and persistent long standing pain after TKA is increased in this patient population.
Pulsed shortwave therapy negates central sensitization by imputing new
- Conditions
- Total Knee Arthroplasty
- Being tested
- pulsed shortwave therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed shortwave therapyDevice
Also called RecoveryRx
Pulsed shortwave therapy us the RecoveryRx device. Emits a pulsed signal a the 27.12Mhz wavelength
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Active comparator | Pulsed shortwave therapy device used as an adjunct therapy immediately on the completion of the operation Receives: Device: pulsed shortwave therapy |
| Control Group | Sham comparator | Sham pulsed shortwave therapy device used as an adjunct therapy immediately on the completion of the operation Receives: Device: pulsed shortwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogue Pain
The visual analog scale (VAS) has been used extensively for rating pain intensity in previous studies. Postoperative pain at 2, 6, 10, 18, 26, 34, 42, 50, 58, 64, and 72 hours after surgery will be recorded using a 10-cm horizontal line with 1-cm vertical lines at each end labeled "no pain" (left side) and "worst possible pain" (right side). VAS scores will also be recorded also at day 4, 7, 14 and 28 and finally at three months. Different time point assessments are being conducted to look at the change in pain level from baseline through recovery.
Measured: Change in pain levels over 3 months
Secondary outcomes (6)
The Oxford Knee Score
The Oxford Knee Score (OKS) is a 12-item patient-reported PRO specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is short, reproducible, valid and sensitive to clinically important changes.
Measured: 3 months
The Knee Injury and Osteoarthritis Outcome Score
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).
Measured: 3 months
Pain Pressure Threshold
Pain Pressure Threshold, is used routinely in clinical practice to assess pain sensitivity from musculoskeletal pain to indicate the level of pain sensitivity in individuals to central sensitization of the nervous system. Testing will occur locally above the effected knee as well as peripherally on the distal interphalangeal joint.
Measured: 3 months
The Pain and Sleep Questionnaire three-item index
The Pain and Sleep Questionnaire three-item index (PSQ-3): A reliable and valid measure of the impact of pain on sleep in chronic nonmalignant pain of various etiologies.
Measured: 3 months
Active Range of Motion
Active range of motion (A-ROM) is an important component of the assessment of total knee replacement (TKR) outcome. The goal of knee replacement recovery is to achieve flexion of 135 degrees. Range of motion will be measured by observational method by two separate individuals.
Measured: 3 months
Analgesic medication use
Analgesic medication use for the postoperative period of 7 days as well as a further 21 days will be recorded - 28 day total.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start15 Dec 2017
- Primary completion15 Dec 2018 (estimated)
- Study completion15 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioElectronics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Omar Tabbouche, Pharm D, Study director, New Mazloum HospitalRaed El Hassan, Dr, Principal investigator, New Mazloum Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395444
- Sponsor's protocol ID
- Biel-TKA-001
- Status last verified
- Dec 2017
- First submitted
- 21 Dec 2017
- Last updated
- 8 Jun 2018
- 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 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Placebo-controlled Clinical Trial to Assess Pulsed Shortwave Therapy as an Adjunct Pain Therapy & Knee Recovery for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03395444
- Acronym / sponsor ID
- Biel-TKA-001
- Conditions
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- BioElectronics CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 15 Mar 2019 (estimated)
- First posted
- 10 Jan 2018 (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.
This clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to the postoperative pain and recovery protocol following total knee replacement. Pulsed shortwave therapy is a safe adjunct pain therapy for acute and chronic pain.
Detailed description
Despite the recent advances in the understanding of pain mechanisms and the introduction of new drugs and new techniques in the postoperative management, pain after total knee arthroplasty (TKA) is still an unresolved issue. It affects the quality of life and rehabilitation of an important percentage of patients undergoing TKA. A recent study looked at the percentage of patients with chronic knee pain after knee replacement at a minimum of one year following surgery in 272 patients, 107 patients (nearly 40%) reported that they still had persistent pain at one-plus year following surgery. Central sensitization is now well established as an integral factor in many chronic pain states, including the commonly occurring knee and back pain. Many patients undergoing TKA are likely to have a significant degree of Central Sensitization, therefore the likely hood of high pain levels postoperative and persistent long standing pain after TKA is increased in this patient population.
Pulsed shortwave therapy negates central sensitization by imputing new
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Device: pulsed shortwave therapyPulsed shortwave therapy device used as an adjunct therapy immediately on the completion of the operation |
| Control Group | Sham comparator | Device: pulsed shortwave therapySham pulsed shortwave therapy device used as an adjunct therapy immediately on the completion of the operation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet the diagnostic criteria for knee osteoarthritis;
- Planned spinal anesthesia; American Society of Anesthesiologists (ASA) physical status I-II;
- Scheduled for unilateral TKA;
- Patients aged 50 to 80 years old.
- Willingness to give written informed consent and willingness to participate in and comply with the study.
Key exclusion criteria (5 listed)
- Unwillingness of the patient;
- Presence of neuropathic pain or sensory disorders in the leg to be operated on;
- Intolerance to the study drugs;
- Failure of spinal anesthesia;
- Previous major knee surgery, re-operation or trauma to the knee within the study period.
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 |
|---|---|---|
| pulsed shortwave therapyAlso: RecoveryRxPulsed shortwave therapy us the RecoveryRx device. Emits a pulsed signal a the 27.12Mhz wavelength | Device | Control Group, Study Group |
Primary outcome
Change in Visual Analogue Pain
Time frame: Change in pain levels over 3 months
The visual analog scale (VAS) has been used extensively for rating pain intensity in previous studies. Postoperative pain at 2, 6, 10, 18, 26, 34, 42, 50, 58, 64, and 72 hours after surgery will be recorded using a 10-cm horizontal line with 1-cm vertical lines at each end labeled "no pain" (left side) and "worst possible pain" (right side). VAS scores will also be recorded also at day 4, 7, 14 and 28 and finally at three months. Different time point assessments are being conducted to look at the change in pain level from baseline through recovery.
6 secondary outcomes
The Oxford Knee Score
Time frame: 3 months
The Knee Injury and Osteoarthritis Outcome Score
Time frame: 3 months
Pain Pressure Threshold
Time frame: 3 months
The Pain and Sleep Questionnaire three-item index
Time frame: 3 months
Active Range of Motion
Time frame: 3 months
Analgesic medication use
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Omar Tabbouche, Pharm D study director
New Mazloum Hospital
Raed El Hassan, Dr principal investigator
New Mazloum Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed shortwave therapy in people with Total Knee Arthroplasty, run by BioElectronics Corporation at 1 site in Lebanon.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Jun 2018. 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 Lebanon. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Maassarani, Ph.D (96179156547, M.masarani@outlook.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analogue Pain (time frame: Change in pain levels over 3 months). 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 Jun 2018.