Effects of TENS Therapy Following Arthroscopic Knee Surgery

Meniscus Tear Clinical Trial

— TENS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528228
• Other study ID #: TENS Study #110518-001
• Status: Completed
• Phase: N/A
• Start date: July 1, 2011
• Est. completion date: April 1, 2012

Study information

• Verified date: January 2019
• Source: A.T. Still University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 1, 2012
• Est. primary completion date: April 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Meniscus Tear

Intervention

Device:
• TENS Treatment with functional or disabled unit
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.

Locations

Country	Name	City	State
United States	North Missouri Sports Medicine and Orthopaedic Surgery	Kirksville	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
A.T. Still University of Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (46)

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.