Pulsed Shortwave Therapy Adjunct Pain and Recovery in Total Knee Replacement

NCT03395444 | Unknown

• 1 other identifier: Biel-TKA-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The Oxford Knee Score

  3 months

• The Knee Injury and Osteoarthritis Outcome Score

  3 months

• Pain Pressure Threshold

  3 months

• The Pain and Sleep Questionnaire three-item index

  3 months

• Active Range of Motion

  3 months

Study Arms (2)

Study Group

ACTIVE COMPARATOR

Pulsed shortwave therapy device used as an adjunct therapy immediately on the completion of the operation

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

Device: pulsed shortwave therapy

Interventions

pulsed shortwave therapy DEVICE

Pulsed shortwave therapy us the RecoveryRx device. Emits a pulsed signal a the 27.12Mhz wavelength

Also known as: RecoveryRx

Control Group; Study Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioElectronics Corporation: lead

Study Sites (1)

New Mazloum Hospital

Tripoli, Lebanon

RECRUITING

Study Officials

• Omar Tabbouche, Pharm D

  New Mazloum Hospital

  STUDY DIRECTOR

• Raed El Hassan, Dr

  New Mazloum Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Maassarani, Ph.D

CONTACT

96179156547; M.masarani@outlook.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 10, 2018
• Study Start: December 15, 2017
• Primary Completion: December 15, 2018
• Study Completion: March 15, 2019
• Last Updated: June 8, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)