Neuromuscular Electrical Stimulation and Ultrasound Therapies , Knee Osteoarthritis

Recep Tayyip Erdogan University Medical School

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: ultrasound therapy; Other: neuromuscular electrical stimulation application

Detailed Description

All participants who were satisfied with the inclusion criteria were randomly assigned to one of two study groups: Group 1- ultrasound therapy group; Group 2 - the neuromuscular electrical stimulation group. Group allocation was randomized in two blocks of 30 sealed envelopes without external marks, which were mixed and numbered from 1 to 30, containing a piece of paper with the group allocation. The researchers responsible for outcome measures and ultrasonograhic measurements were blinded to the patients' diagnosis or intervention.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Rize, Turkey, 53100
    • Gul Devrimsel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

1. Inclusion Criteria:

   Clinical diagnosis of knee osteoarthritis

2. Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 patients; Patients have grade 2 or 3 knee osteoarthritis ultrasound therapy	Other: ultrasound therapy; Group 1, ultrasound therapy ;1 watt/cm² dose, 1 MHz, 5 minutes
Active Comparator: Group 2 patients; Patients have grade 2 or 3 knee osteoarthritis neuromuscular electrical stimulation application	Other: neuromuscular electrical stimulation application; Group 2, neuromuscular electrical stimulation application;20 mins/session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital
• Investigators: Study Director: GUL DEVRIMSEL, Dr.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): August 30, 2017
• Study Completion (Actual): October 30, 2017

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2018
• Last Update Submitted That Met QC Criteria: October 30, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: knee osteoarthritis; neuromuscular electrical stimulation; ultrasound therapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: No sponsor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No