Neuromuscular Electrical Stimulation and Ultrasound Therapies , Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Recep Tayyip Erdogan University Medical School

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727256
• Other study ID #: No sponsor
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: October 30, 2017

Study information

• Verified date: October 2018
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• ultrasound therapy
Group 1, ultrasound therapy ;1 watt/cm² dose, 1 MHz, 5 minutes
• neuromuscular electrical stimulation application
Group 2, neuromuscular electrical stimulation application;20 mins/session

Locations

Country	Name	City	State
Turkey	Gul Devrimsel	Rize

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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