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Pulsed Shortwave Therapy Adjunct Pain and Recovery in Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT03395444
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
BioElectronics Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Device: pulsed shortwave therapy Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind Placebo-controlled Clinical Trial to Assess Pulsed Shortwave Therapy as an Adjunct Pain Therapy & Knee Recovery for Total Knee Arthroplasty
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Study Group
Pulsed shortwave therapy device used as an adjunct therapy immediately on the completion of the operation
Device: pulsed shortwave therapy
Pulsed shortwave therapy us the RecoveryRx device. Emits a pulsed signal a the 27.12Mhz wavelength
Other Name: RecoveryRx

Sham Comparator: Control Group
Sham pulsed shortwave therapy device used as an adjunct therapy immediately on the completion of the operation
Device: pulsed shortwave therapy
Pulsed shortwave therapy us the RecoveryRx device. Emits a pulsed signal a the 27.12Mhz wavelength
Other Name: RecoveryRx




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The Oxford Knee Score [ Time Frame: 3 months ]
    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.

  2. The Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 3 months ]
    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).

  3. Pain Pressure Threshold [ Time Frame: 3 months ]
    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.

  4. The Pain and Sleep Questionnaire three-item index [ Time Frame: 3 months ]
    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.

  5. Active Range of Motion [ Time Frame: 3 months ]
    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.

  6. Analgesic medication use [ Time Frame: 28 days ]
    Analgesic medication use for the postoperative period of 7 days as well as a further 21 days will be recorded - 28 day total.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395444


Contacts
Contact: Mahmoud Maassarani, Ph.D 96179156547 M.masarani@outlook.fr

Locations
Lebanon
New Mazloum Hospital Recruiting
Tripoli, Lebanon
Contact: Mahmoud Masarani, Ph.D    96179156547    M.masarani@outlook.fr   
Sponsors and Collaborators
BioElectronics Corporation
Investigators
Study Director: Omar Tabbouche, Pharm D New Mazloum Hospital
Principal Investigator: Raed El Hassan, Dr New Mazloum Hospital

Responsible Party: BioElectronics Corporation
ClinicalTrials.gov Identifier: NCT03395444     History of Changes
Other Study ID Numbers: Biel-TKA-001
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No