The Efficacy of Exercise and Alternative Applications of NMES on Pain and Function in Patients With Knee OA

NCT03571698 | Completed DMC

• 1 other identifier: IstU
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study was to investigate the efficacy of exercise and different size electrodes of neuromuscular electrical stimulation (NMES) applications on pain, range of motion (ROM), muscle strength, function status and depression in knee osteoarthritis. 60 voluntary patients were included in the study and these patients divided into three groups randomly. For Group 1 only exercise, for Group 2 simultaneously active contraction with NMES with standard size electrodes, for Group 3 simultaneously active contraction with NMES with large electrodes applied for 3 days per week, 18 session. Pain was measured with Visual analog Scale (VAS), ROM was measured with digital goniometer, muscle strength was measured with "Hand-held" dynamometer (Lafayette Instrument®, Lafayette, IN), functional status were measured with WOMAC (Western Ontario and McMaster Universities) Index and stair climbing test, balance was analysed with one leg standing test, depression was scored with Hospital Anxiety Depression Scale and patients satisfaction was scored with Global Rating Change Scales. The cases evaluated before and after treatment.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Neuromuscular Electrical Stimulation; Exercise; Pain; Function

Outcome Measures

Primary Outcomes (2)

• Visual Analoque Scale

  Pain intensity was assessed using the VAS; each patient was asked the pain during the rest, activity, and at night time.

  The rest, night time and pain in activity were assessed by VAS before treatment versus after 6 weeks of treatment.

• Knee Extensor Muscle Strength

  Quadriceps Femoris Muscle strength was measured using a Hand-held Dynomometer.

  Quadriceps Femoris Muscle strength was measured before treatment versus after 6 weeks of treatment.

Secondary Outcomes (7)

• Knee Range of Motion

  Knee Flexion and extension were measured with Digital Goniometer on sitting position before treatment versus after 6 weeks.

• Knee Range of Motion

  Knee Flexion and extension were taken using Digital Goniometer before treatment versus after 6 weeks treatent.

• Muscle Strength using a Hand-held Dynomometer

  Hip flexor, extensor, adductor, abductor groups muscles, knee flexor groups muscles strength were measaured before treatment versus after 6 weeks of treatment.

• WOMAC (Western Ontario and McMaster Universities Index)

  Pain, stiffness and physical function were assessed by WOMAC before treatment versus after 6 weeks of treatment.

• Stair Climbimg Test (SCT)

  Balance was assessed by SCT before treatment versus after 6 weeks of treatment.

Study Arms (3)

Exercise programme only

NO INTERVENTION

The treatment group received only exercise programme. The exercises was done by a physical therapist in clinical center. The treatment group received exercise programme with simultaneously active contraction with NMES with large electrodes.

Exercise with NMES standard electrodes

ACTIVE COMPARATOR

The treatment group received exercise programme with simultaneously active contraction with NMES with standard electrodes.The exercises was done by a physical therapist in clinical center. The treatment group received exercise programme with simultaneously active contraction with NMES with large electrodes.

Device: Neuromuscular Electrical Stimulator

Exercise with NMES large electrodes

ACTIVE COMPARATOR

The treatment group received exercise programme with simultaneously active contraction with NMES with large electrodes.The exercises was done by a physical therapist in clinical center. The treatment group received exercise programme with simultaneously active contraction with NMES with large electrodes.

Device: Neuromuscular Electrical Stimulator

Interventions

Neuromuscular Electrical Stimulator DEVICE

The treatment group received exercise programme with simultaneously active contraction with NMES with large or standart electrodes.

Exercise with NMES large electrodes; Exercise with NMES standard electrodes

Eligibility Criteria

• Age: 47 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acceppting to participate Being between 45-74 years according to the description of the World Health Organisation Being women Having Osteoarthritis on right knee. Having the symptoms of Grade 2-3 according to Kellgren ve Lawrence Classification Having a value below 30 according to Body Mass Index

You may not qualify if:

• Not accepting to partipate Having left knee Osteoarthritis Having an orthopedic problem on lower extremity Having uncontrollable hypertension Having arteriovenous problem on lower extremity Having confusion about regular participation Having a neurogical problem Having learning and perception problem Having heart implant Being included in physiotherapy and rehabilitation program for knee OA in last 6 month Having injection application for knee in last 6 month

Sponsors & Collaborators

• Istanbul University: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yıldız Analay Akbaba, Assist Prof.

  Istanbul University

  STUDY DIRECTOR

• Ekin Aktay, MSc

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist Master in Science

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 27, 2018
• Study Start: October 15, 2016
• Primary Completion: August 2, 2017
• Study Completion: August 2, 2017
• Last Updated: June 27, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share