Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Postoperative Pain and Function Following Arthroscopic Knee Surgery: A Prospective Randomized Clinical Trial Pilot Study
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
This group will be given an active TENS unit to use.
Intervention: TENS Treatment with functional or disabled unit (Device)
Sham TENS Therapy
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