Pulsed Shortwave Therapy Adjunct Pain and Recovery in Total Knee Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-15

Study Completion Date

2019-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pulsed Shortwave Therapy for Postoperative Analgesia

NCT05796583

Postoperative Pain, Acute

COMPLETED NA

Effect of Pulsed Signal Therapy in Patella Chondromalacia

NCT02012413

Patella Chondromalacia

COMPLETED NA

Pulsed Electromagnetic Fields for Post-Amputation Pain

NCT05392803

Phantom Limb Pain Residual Limb Pain

COMPLETED NA

Shock Wave Therapy Versus Neuromuscular Training in Women With Patellofemoral Pain

NCT03324204

Patellofemoral Pain Syndrome Knee Pain Chronic

UNKNOWN NA

Study of Effectiveness and Safety of Extracorporeal Shock Wave Therapy (ESWT) for Treatment of Painful Heel Syndrome

NCT00720694

Plantar Fasciitis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Total Knee Arthroplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Group

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

Group Type ACTIVE_COMPARATOR

pulsed shortwave therapy

Intervention Type DEVICE

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

Control Group

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

Group Type SHAM_COMPARATOR

pulsed shortwave therapy

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pulsed shortwave therapy

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RecoveryRx

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No