NCT03727256

Brief Summary

To determine the effects of ultrasound therapy and neuromuscular electrical stimulation on the muscle architecture and functional capacity of patients with knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

October 22, 2018

Last Update Submit

October 30, 2018

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritisneuromuscular electrical stimulationultrasound therapy

Outcome Measures

Primary Outcomes (4)

  • Visual analog scale

    Pain was assessed using a 0 to 10 visual analogue pain scale, with 0 meaning 'no pain' and 10 meaning 'excruciating pain'.

    3 weeks

  • Western Ontario and McMaster Universities Arthritis Index

    The WOMAC (Westren Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee using 24 parameters.To assess pain, stiffness, and physical function in patients with hip and / or knee osteoarthritis, Minimum total score: 0, maximum total score: 96.Disability scores increase as Womac osteoarthritis index scores increase.

    3 weeks

  • 15 meter walking test

    The patients were asked to walk as fast as possible along a level, unobstructed corridor on the command "go." The patients stood before the starting line. A hand-held stopwatch was started as the subjects passed a predetermined start mark and stopped as they passed a second mark 15meter from the start mark.Walking duration was determined as second before and after treatment

    3 weeks

  • Muscle measurements were made before and after treatment.

    Ultrasonography was used to measure muscle thickness, pennation angle and fascicle length. Muscle thickness was measured as the mean distance between the superficial and deep aponeurosis at both image muscles. The distance between the intersection composed of the superficial aponeurosis and muscle fascicle, and the intersection composed of the deep aponeurosis and muscle fascicle was defined as muscle fascicle length. The results was measured as millimeter.The angle between the muscle fascicle and deep aponeurosis was defined as Pennation angle.

    3 weeks

Study Arms (2)

Group 1 patients

ACTIVE COMPARATOR

Patients have grade 2 or 3 knee osteoarthritis ultrasound therapy

Other: ultrasound therapy

Group 2 patients

ACTIVE COMPARATOR

Patients have grade 2 or 3 knee osteoarthritis neuromuscular electrical stimulation application

Other: neuromuscular electrical stimulation application

Interventions

ultrasound therapyOTHER

Group 1, ultrasound therapy ;1 watt/cm² dose, 1 MHz, 5 minutes

Group 1 patients
neuromuscular electrical stimulation applicationOTHER

Group 2, neuromuscular electrical stimulation application;20 mins/session

Group 2 patients

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of knee osteoarthritis

You may not qualify if:

  • Cardiovascular diseases
  • Inflammatory diseases
  • Infectious diseases
  • Lower extremity weakness
  • Tumoral diseases
  • Knee surgery in the past six months
  • Intra-articular injection in the past six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gul Devrimsel

Rize, 53100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeutics

Study Officials

  • GUL DEVRIMSEL

    Dr.

    STUDY DIRECTOR

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
Principal Investigator

Study Record Dates

First Submitted

October 22, 2018

First Posted

November 1, 2018

Study Start

February 1, 2017

Primary Completion

August 30, 2017

Study Completion

October 30, 2017

Last Updated

November 1, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)