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.

Study Overview

• Status: Unknown
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Device: pulsed shortwave therapy

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
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud Maassarani, Ph.D; Phone Number: 96179156547; Email: M.masarani@outlook.fr

Study Locations

• Lebanon
  • Tripoli, Lebanon
    • Recruiting
    • New Mazloum Hospital
    • Contact: Mahmoud Masarani, Ph.D; Phone Number: 96179156547; Email: M.masarani@outlook.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: RecoveryRx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change in pain levels over 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	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.	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.	28 days

Collaborators and Investigators

• Sponsor: BioElectronics Corporation
• Investigators: Principal Investigator: Raed El Hassan, Dr, New Mazloum Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Anticipated): December 15, 2018
• Study Completion (Anticipated): March 15, 2019

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 10, 2018

Study Record Updates

• Last Update Posted (Actual): June 8, 2018
• Last Update Submitted That Met QC Criteria: June 7, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Biel-TKA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No