Clinical trial NCT03395444: Pulsed Shortwave Therapy Adjunct Pain and Recovery in Total Knee Replacement
Official title: Double Blind Placebo-controlled Clinical Trial to Assess Pulsed Shortwave Therapy as an Adjunct Pain Therapy & Knee Recovery for Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: BioElectronics Corporation
Sponsor class: INDUSTRY
First posted: 2018-01-10
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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.

Primary outcomes:
measure: Change in Visual Analogue Pain
timeFrame: Change in pain levels over 3 months
Secondary outcomes:
measure: The Oxford Knee Score
timeFrame: 3 months
measure: The Knee Injury and Osteoarthritis Outcome Score
timeFrame: 3 months
measure: Pain Pressure Threshold
timeFrame: 3 months
measure: The Pain and Sleep Questionnaire three-item index
timeFrame: 3 months
measure: Active Range of Motion
timeFrame: 3 months
measure: Analgesic medication use
timeFrame: 28 days
Other outcomes:
Locations:
city: Tripoli
country: Lebanon
facility: New Mazloum Hospital
Study officials:
affiliation: New Mazloum Hospital
name: Omar Tabbouche, Pharm D
role: STUDY_DIRECTOR
affiliation: New Mazloum Hospital
name: Raed El Hassan, Dr
role: PRINCIPAL_INVESTIGATOR
References: