Pulsed Shortwave Therapy Adjunct Pain and Recovery in Total Knee Replacement

BioElectronics Corporation

Status: Unknown

Conditions: Total Knee Arthroplasty

Treatments: Device: pulsed shortwave therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03395444

Biel-TKA-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Study Group

Active Comparator group

Description:

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

Treatment:

Device: pulsed shortwave therapy

Control Group

Sham Comparator group

Description:

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

Treatment:

Device: pulsed shortwave therapy