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Neuromuscular Electrical Stimulation and Ultrasound Therapies , Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03727256
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Gul Devrimsel, Recep Tayyip Erdogan University Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: ultrasound therapy Other: neuromuscular electrical stimulation application Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Recep Tayyip Erdogan University Medical School
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : August 30, 2017
Actual Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Visual analog scale [ Time Frame: 3 weeks ]
    Pain was assessed using a 0 to 10 visual analogue pain scale, with 0 meaning 'no pain' and 10 meaning 'excruciating pain'.

  2. Western Ontario and McMaster Universities Arthritis Index [ Time Frame: 3 weeks ]
    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. 15 meter walking test [ Time Frame: 3 weeks ]
    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

  4. Muscle measurements were made before and after treatment. [ Time Frame: 3 weeks ]
    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.



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727256


Locations
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Turkey
Gul Devrimsel
Rize, Turkey, 53100
Sponsors and Collaborators
Recep Tayyip Erdogan University Training and Research Hospital
Investigators
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Study Director: GUL DEVRIMSEL Dr.

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Responsible Party: Gul Devrimsel, Principal Investigator, Recep Tayyip Erdogan University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03727256    
Other Study ID Numbers: No sponsor
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gul Devrimsel, Recep Tayyip Erdogan University Training and Research Hospital:
knee osteoarthritis
neuromuscular electrical stimulation
ultrasound therapy
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases