Trial record 1 of 3 for:    total knee replacement | Lebanon
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Pulsed Shortwave Therapy Adjunct Pain and Recovery in Total Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03395444
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : June 8, 2018
Information provided by (Responsible Party):
BioElectronics Corporation

December 21, 2017
January 10, 2018
June 8, 2018
December 15, 2017
December 15, 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03395444 on Archive Site
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
Pulsed Shortwave Therapy Adjunct Pain and Recovery in Total Knee Replacement
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.

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

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Total Knee Arthroplasty
Device: pulsed shortwave therapy
Pulsed shortwave therapy us the RecoveryRx device. Emits a pulsed signal a the 27.12Mhz wavelength
Other Name: RecoveryRx
  • Active Comparator: Study Group
    Pulsed shortwave therapy device used as an adjunct therapy immediately on the completion of the operation
    Intervention: Device: pulsed shortwave therapy
  • Sham Comparator: Control Group
    Sham pulsed shortwave therapy device used as an adjunct therapy immediately on the completion of the operation
    Intervention: Device: pulsed shortwave therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 15, 2019
December 15, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years to 80 Years   (Adult, Older Adult)
Contact: Mahmoud Maassarani, Ph.D 96179156547
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
BioElectronics Corporation
BioElectronics Corporation
Not Provided
Study Director: Omar Tabbouche, Pharm D New Mazloum Hospital
Principal Investigator: Raed El Hassan, Dr New Mazloum Hospital
BioElectronics Corporation
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP