NCT03588195

Brief Summary

Sixty patients with a diagnosis of knee osteoarthritis, aged between 40 and 80 years, of both genders were included. The patients were divided into: experimental group that carried out an educational program - 5 consecutive sessions held once a week, with a duration of 60 minutes each class and at the end of the last class, a booklet was delivered for each patient with all the contents of the classes and the Transcutaneous Nerve Electro-Stimulation device - being performed twice weekly, for 5 weeks for 40 minutes each session; and control group who only underwent treatment with the Transcutaneous Nerve Electro-Stimulation in the same parameters as experimental group. The evaluations were performed at the beginning of the treatment, 4 and 12 weeks after the beginning of the treatment using a numerical pain scale; WOMAC; IDATE and SF-36 questionnaires; and 6-minute walk test.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable knee-osteoarthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

1.7 years

First QC Date

July 4, 2018

Last Update Submit

July 24, 2018

Conditions

Knee Osteoarthritis

Keywords

EducationPainFunctionQuality of life

Outcome Measures

Primary Outcomes (1)

  • Change in Pain

    Evaluated using a numeric pain scale

    Baseline and after 4 and 12 weeks

Secondary Outcomes (4)

  • Change in function

    Baseline and after 4 and 12 weeks

  • Change in Anxiety

    Baseline and after 4 and 12 weeks

  • Change in Generic Quality of life

    Baseline and after 4 and 12 weeks

  • Change in Functional capacity

    Baseline and after 4 and 12 weeks

Study Arms (2)

Education Group

EXPERIMENTAL
Other: Educational ProgramDevice: Transcutaneous Nerve Electro-Stimulation

Control Group

ACTIVE COMPARATOR
Device: Transcutaneous Nerve Electro-Stimulation

Interventions

Educational ProgramOTHER

Educational program consist in 5 consecutive sessions held once a week, with a duration of 60 minutes each class and at the end of the last class, a booklet was delivered for each patient with all the contents of the classes. This group also received Transcutaneous Nerve Electro-Stimulation twice weekly, for 5 weeks for 40 minutes each session

Education Group
Transcutaneous Nerve Electro-StimulationDEVICE

Transcutaneous Nerve Electro-Stimulation performed twice weekly, for 5 weeks for 40 minutes each session

Control GroupEducation Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of knee Osteoarthritis by American College of Rheumatology criteria;
  • Age between 40 and 80 years;
  • Both genders;
  • Numerical Pain Scale in the knee between 3 and 8 centimeters on a scale of 0 to 10 centimeters.

You may not qualify if:

  • Systemic inflammatory diseases or any condition that prevents the practice of physical activity;
  • Regular physical activity started or changed in the last twelve weeks;
  • No ambulation;
  • Joint injection in the knee in the previous twelve weeks;
  • Previous knee surgery or surgery planned for the next twenty-four weeks;
  • Physiotherapy in the last twelve weeks;
  • Other disease that affects the lower limbs;
  • Open wounds at the electrode application site;
  • Planned trip in the next twelve weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneePain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 4, 2018

First Posted

July 17, 2018

Study Start

February 1, 2016

Primary Completion

October 24, 2017

Study Completion

June 17, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07