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Clinical Trials/NCT01528228
NCT01528228CompletedNot Applicable

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

A.T. Still University of Health Sciences2 sites in 1 country20 target enrollmentStarted: July 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 18-60
  • 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

Arms & Interventions

Structured TENS Therapy

Active Comparator

This group will be given an active TENS unit to use.

Intervention: TENS Treatment with functional or disabled unit (Device)

Sham TENS Therapy

Sham Comparator

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.

Intervention: TENS Treatment with functional or disabled unit (Device)

Outcomes

Primary Outcomes

Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.

Time Frame: Two weeks postoperatively.

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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