Effects of TENS Therapy Following Arthroscopic Knee Surgery

Study Overview
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Brief Summary
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Following standard of care procedures for arthroscopy knee surgery it is anticipated that Transcutaneous Electrical Nerve Stimulation (TENS) will provide improved pain relief and improve functional outcomes.

Official Title
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Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Postoperative Pain and Function Following Arthroscopic Knee Surgery: A Prospective Randomized Clinical Trial Pilot Study

Conditions
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Meniscus Tear

Intervention / Treatment
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* Device: TENS Treatment with functional or disabled unit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-60 BMI<50 No significant joint malalignment No significant ligamentous instability No significant radiographic joint space narrowing No prior significant knee surgery Unilateral knee surgery Not workman's compensation Planned knee arthroscopy for meniscectomy, chondroplasty or synovectomy Exclusion Criteria: Age <18 or >60 BMI > 50 Significant joint malalignment Significant ligamentous instability Significant radiographic joint space narrowing Prior significant knee surgery Bilateral knee surgery planned Worker's Compensation No planned knee arthroscopy for menisectomy, chondroplasty or synovectomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Structured TENS Therapy<br>This group will be given an active TENS unit to use. | Device: TENS Treatment with functional or disabled unit<br>* TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units.<br>* Other names: EMPI Select Pain Control System;|
| Sham Comparator: Sham TENS Therapy<br>This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse. | Device: TENS Treatment with functional or disabled unit<br>* TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units.<br>* Other names: EMPI Select Pain Control System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | The patient participant will record pain levels during the immediate post-op 2-week time period every day. Day 0 is pain level before surgery. Pain perception measured on a scale from 0-10 with 0 representing no or lowest level pain and 10 representing the highest level of pain | Two weeks postoperatively. |