Meniscus TearTENSNCT01528228

Effects of TENS Therapy Following Arthroscopic Knee Surgery

A study testing TENS Treatment with functional or disabled unit in people with Meniscus Tear, run by A.T. Still University of Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Meniscus Tear
What is being tested?: TENS Treatment with functional or disabled unit
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2011to 1 Apr 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age 18-60
BMI<50
No significant joint malalignment
No significant ligamentous instability
No significant radiographic joint space narrowing
No prior significant knee surgery

Show all 9Show fewer

Unilateral knee surgery
Not workman's compensation
Planned knee arthroscopy for meniscectomy, chondroplasty or synovectomy

Who cannot join

Age <18 or >60
BMI > 50
Significant joint malalignment
Significant ligamentous instability
Significant radiographic joint space narrowing
Prior significant knee surgery

Show all 9Show fewer

Bilateral knee surgery planned
Worker's Compensation
No planned knee arthroscopy for menisectomy, chondroplasty or synovectomy

Trial locations and contacts

1 site in 1 country.

United States1 site

North Missouri Sports Medicine and Orthopaedic Surgery
Kirksville, Missouri, 63501

Other trials in United States

About this study

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

Conditions: Meniscus Tear
Being tested: TENS Treatment with functional or disabled unit

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TENS Treatment with functional or disabled unitDevice
Also called EMPI Select Pain Control System
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.

Study groups in NCT01528228
Study group	Role	What they receive
Structured TENS Therapy	Active comparator	This group will be given an active TENS unit to use. Receives: Device: TENS Treatment with functional or disabled unit
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. Receives: Device: TENS Treatment with functional or disabled unit

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Two weeks postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20111 Apr 2012

First posted7 Feb 2012 (estimated)
Study start1 Jul 2011
Primary completion1 Apr 2012
Study completion1 Apr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (46)Papers the sponsor has linked to this study.
Other trials for Meniscus TearStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01528228
Sponsor's protocol ID: TENS Study #110518-001
Acronym: TENS
Status last verified: Jan 2019
First submitted: 3 Feb 2012
Last updated: 11 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Breit R, Van der Wall H. Transcutaneous electrical nerve stimulation for postoperative pain relief after total knee arthroplasty. J Arthroplasty. 2004 Jan;19(1):45-8. doi: 10.1016/s0883-5403(03)00458-3.
PubMed 14716650
Lewek M, Stevens J, Snyder-Mackler L. The use of electrical stimulation to increase quadriceps femoris muscle force in an elderly patient following a total knee arthroplasty. Phys Ther. 2001 Sep;81(9):1565-71. doi: 10.1093/ptj/81.9.1565.
PubMed 11688592
Paternostro-Sluga T, Fialka C, Alacamliogliu Y, Saradeth T, Fialka-Moser V. Neuromuscular electrical stimulation after anterior cruciate ligament surgery. Clin Orthop Relat Res. 1999 Nov;(368):166-75.
PubMed 10613165
Wang B, Tang J, White PF, Naruse R, Sloninsky A, Kariger R, Gold J, Wender RH. Effect of the intensity of transcutaneous acupoint electrical stimulation on the postoperative analgesic requirement. Anesth Analg. 1997 Aug;85(2):406-13. doi: 10.1097/00000539-199708000-00029.
PubMed 9249122
Hargreaves A, Lander J. Use of transcutaneous electrical nerve stimulation for postoperative pain. Nurs Res. 1989 May-Jun;38(3):159-61.
PubMed 2785684
Arvidsson I, Eriksson E. Postoperative TENS pain relief after knee surgery: objective evaluation. Orthopedics. 1986 Oct;9(10):1346-51. doi: 10.3928/0147-7447-19861001-06.
PubMed 3490659
Tyler E, Caldwell C, Ghia JN. Transcutaneous electrical nerve stimulation: an alternative approach to the management of postoperative pain. Anesth Analg. 1982 May;61(5):449-56. No abstract available.
PubMed 6175251
Neary JM. Transcutaneous electrical nerve stimulation for the relief of post-incisional surgical pain. AANA J. 1981 Apr;49(2):151-5. No abstract available.
PubMed 6111884
Cooperman AM, Hall B, Mikalacki K, Hardy R, Sardar E. Use of transcutaneous electrical stimulation in the control of postoperative pain. Am J Surg. 1977 Feb;133(2):185-7. doi: 10.1016/0002-9610(77)90077-0.
PubMed 319697
Selfe TK, Taylor AG. Acupuncture and osteoarthritis of the knee: a review of randomized, controlled trials. Fam Community Health. 2008 Jul-Sep;31(3):247-54. doi: 10.1097/01.FCH.0000324482.78577.0f.
PubMed 18552606
Eyigor S, Karapolat H, Ibisoglu U, Durmaz B. [Does transcutaneous electrical nerve stimulation or therapeutic ultrasound increase the effectiveness of exercise for knee osteoarthritis: a randomized controlled study]. Agri. 2008 Jan;20(1):32-40. Turkish.
PubMed 18338277
Cetin N, Aytar A, Atalay A, Akman MN. Comparing hot pack, short-wave diathermy, ultrasound, and TENS on isokinetic strength, pain, and functional status of women with osteoarthritic knees: a single-blind, randomized, controlled trial. Am J Phys Med Rehabil. 2008 Jun;87(6):443-51. doi: 10.1097/PHM.0b013e318174e467.
PubMed 18496246
Burch FX, Tarro JN, Greenberg JJ, Carroll WJ. Evaluating the benefits of patterned stimulation in the treatment of osteoarthritis of the knee: a multi-center, randomized, single-blind, controlled study with an independent masked evaluator. Osteoarthritis Cartilage. 2008 Aug;16(8):865-72. doi: 10.1016/j.joca.2007.11.013. Epub 2008 Feb 8.
PubMed 18262443
Kang RW, Lewis PB, Kramer A, Hayden JK, Cole BJ. Prospective randomized single-blinded controlled clinical trial of percutaneous neuromodulation pain therapy device versus sham for the osteoarthritic knee: a pilot study. Orthopedics. 2007 Jun;30(6):439-45. doi: 10.3928/01477447-20070601-11. No abstract available.
PubMed 17598487
Paker N, Tekdos D, Kesiktas N, Soy D. Comparison of the therapeutic efficacy of TENS versus intra-articular hyaluronic acid injection in patients with knee osteoarthritis: a prospective randomized study. Adv Ther. 2006 Mar-Apr;23(2):342-53. doi: 10.1007/BF02850139.
PubMed 16751166

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Meniscus Tear trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01528228
Acronym / sponsor ID: TENS / TENS Study #110518-001
Conditions: Meniscus Tear
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: A.T. Still University of Health SciencesUniversity, hospital or other
Study start: 1 Jul 2011
Primary completion: 1 Apr 2012 (actual)
Study completion: 1 Apr 2012 (actual)
First posted: 7 Feb 2012 (estimated)
Results: Posted 11 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Structured TENS Therapy	Active comparator	Device: TENS Treatment with functional or disabled unitThis group will be given an active TENS unit to use.
Sham TENS Therapy	Sham comparator	Device: TENS Treatment with functional or disabled unitThis group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Age 18-60
BMI<50
No significant joint malalignment
No significant ligamentous instability
No significant radiographic joint space narrowing

Key exclusion criteria (9 listed)

Age <18 or >60
BMI > 50
Significant joint malalignment
Significant ligamentous instability
Significant radiographic joint space narrowing

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TENS Treatment with functional or disabled unitAlso: EMPI Select Pain Control SystemTENS 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.	Device	Sham TENS Therapy, Structured TENS Therapy

Primary outcome

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

Results and safety

Results posted to the registry on 11 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Structured TENS Therapy	10	9
Sham TENS Therapy	10	9

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

Time frame: Two weeks postoperatively.. Least squares mean (95% Confidence Interval). Unit: score on 0-10 pain level scale

Measure	Structured TENS Therapy n = 9	Sham TENS Therapy n = 9
Day 0	5.10 (3.16 to 7.04)	5.24 (3.25 to 7.22)
Day 1	4.68 (2.81 to 6.56)	4.07 (2.19 to 5.95)
Day 2	3.41 (1.54 to 5.28)	3.28 (1.41 to 5.15)
Day 3	2.78 (0.91 to 4.66)	2.95 (1.09 to 4.82)
Day 4	2.49 (0.62 to 4.37)	3.22 (1.36 to 5.09)
Day 5	3.00 (1.13 to 4.88)	3.26 (1.40 to 5.13)
Day 6	2.20 (0.33 to 4.07)	2.72 (0.85 to 4.59)
Day 7	2.42 (0.55 to 4.29)	2.78 (0.92 to 4.65)

Adverse events

Time frame: 2 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Structured TENS Therapy	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Sham TENS Therapy	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 14716650Breit R, Van der Wall H. Transcutaneous electrical nerve stimulation for postoperative pain relief after total knee arthroplasty. J Arthroplasty. 2004 Jan;19(1):45-8. doi: 10.1016/s0883-5403(03)00458-3.
Background: PubMed 11688592Lewek M, Stevens J, Snyder-Mackler L. The use of electrical stimulation to increase quadriceps femoris muscle force in an elderly patient following a total knee arthroplasty. Phys Ther. 2001 Sep;81(9):1565-71. doi: 10.1093/ptj/81.9.1565.
Background: PubMed 10613165Paternostro-Sluga T, Fialka C, Alacamliogliu Y, Saradeth T, Fialka-Moser V. Neuromuscular electrical stimulation after anterior cruciate ligament surgery. Clin Orthop Relat Res. 1999 Nov;(368):166-75.
Background: PubMed 9249122Wang B, Tang J, White PF, Naruse R, Sloninsky A, Kariger R, Gold J, Wender RH. Effect of the intensity of transcutaneous acupoint electrical stimulation on the postoperative analgesic requirement. Anesth Analg. 1997 Aug;85(2):406-13. doi: 10.1097/00000539-199708000-00029.
Background: PubMed 2785684Hargreaves A, Lander J. Use of transcutaneous electrical nerve stimulation for postoperative pain. Nurs Res. 1989 May-Jun;38(3):159-61.
Background: PubMed 3490659Arvidsson I, Eriksson E. Postoperative TENS pain relief after knee surgery: objective evaluation. Orthopedics. 1986 Oct;9(10):1346-51. doi: 10.3928/0147-7447-19861001-06.
Background: PubMed 6175251Tyler E, Caldwell C, Ghia JN. Transcutaneous electrical nerve stimulation: an alternative approach to the management of postoperative pain. Anesth Analg. 1982 May;61(5):449-56. No abstract available.
Background: PubMed 6111884Neary JM. Transcutaneous electrical nerve stimulation for the relief of post-incisional surgical pain. AANA J. 1981 Apr;49(2):151-5. No abstract available.
Background: PubMed 319697Cooperman AM, Hall B, Mikalacki K, Hardy R, Sardar E. Use of transcutaneous electrical stimulation in the control of postoperative pain. Am J Surg. 1977 Feb;133(2):185-7. doi: 10.1016/0002-9610(77)90077-0.
Background: PubMed 18552606Selfe TK, Taylor AG. Acupuncture and osteoarthritis of the knee: a review of randomized, controlled trials. Fam Community Health. 2008 Jul-Sep;31(3):247-54. doi: 10.1097/01.FCH.0000324482.78577.0f.
Background: PubMed 18338277Eyigor S, Karapolat H, Ibisoglu U, Durmaz B. [Does transcutaneous electrical nerve stimulation or therapeutic ultrasound increase the effectiveness of exercise for knee osteoarthritis: a randomized controlled study]. Agri. 2008 Jan;20(1):32-40. Turkish.
Background: PubMed 18496246Cetin N, Aytar A, Atalay A, Akman MN. Comparing hot pack, short-wave diathermy, ultrasound, and TENS on isokinetic strength, pain, and functional status of women with osteoarthritic knees: a single-blind, randomized, controlled trial. Am J Phys Med Rehabil. 2008 Jun;87(6):443-51. doi: 10.1097/PHM.0b013e318174e467.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kevin Marberry, MD principal investigator

A.T. Still University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TENS Treatment with functional or disabled unit in people with Meniscus Tear, run by A.T. Still University of Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. (time frame: Two weeks postoperatively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01528228, which also lists 46 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.