NCT06270329

Brief Summary

The aim of this study was to compare the effects of neuromuscular training program and conventional physical therapy program on pain, functional status, physical performance, balance, muscle strength and quality of life in patients with knee osteoarthritis (KOA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

February 10, 2024

Last Update Submit

February 20, 2024

Conditions

Keywords

Neuromuscular trainingKnee osteoarthritisPhysical therapy

Outcome Measures

Primary Outcomes (6)

  • Visual Analog Scale

    Pain evaluation. The participant is asked to give a score between 1 and 10 for her pain.

    At first and third week

  • Western Ontario and McMasterUniversities Osteoarhritis Index

    Functional status evaluation. The scale consists of 3 subheadings that evaluate pain, stiffness and physical function. High Western Ontario and McMasterUniversities Osteoarhritis Index score indicates increased pain and stiffness and deterioration in physical function.

    At first and third week

  • Time on One Leg Standing

    Balance evaluation. Participants were asked to stand on one leg with their eyes open for as long as possible, and the time was measured with a stopwatch and recorded in seconds.

    At first and third week

  • Five Times Sit to Stand Test

    Physical performance evaluation. The time it takes for the patient to sit and stand up from a chair five times is recorded. As time decreases, it indicates better performance.

    At first and third week

  • Manual Muscle Test

    Muscle strength evaluation. A score between 0 and 5 is given depending on muscle strength.

    At first and third week

  • Short Form

    Quality of life evaluation. It consists of 8 subheadings: physical function, problems caused by physical problems, emotional well-being, problems caused by emotional problems, general health, social function, pain, energy/fatigue. High scores indicate good health, low scores indicate poor health.

    At first and third week

Study Arms (2)

neuromuscular training program

EXPERIMENTAL

Participants were administered the neuromuscular training program 60 min a day, 2 days a week for 8 weeks.

Other: Neuromuscular training program

conventional physical therapy program

ACTIVE COMPARATOR

Participants were administered the conventional physiotherapy program 60 min a day, 2 days a week for 8 weeks.

Other: conventional physical therapy program

Interventions

Hotpack application TENS (transcutaneous electrical stimulation) Warm-up phase: bicycle ergometer (ten minutes) Exercise phase: core stabilization and postural control exercises postural orientation exercises lower extremity strengthening exercises functional exercises (balance and proprioception exercises using a balance board) Cool-down Phase

neuromuscular training program

Hotpack application TENS (transcutaneous electrical stimulation) Conventional physical therapy exercises (straight leg raises, knee flexor and extensor strengthening, hip muscle strengthening)

conventional physical therapy program

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having grade 2 or 3 osteoarthritis according to the Kellgren and Lawrence Classification
  • Having pain score of 2 or above on VAS
  • Not having received physical therapy in the last 3 months
  • Not having received an intra-articular corticosteroid injection in the last 6 months
  • Not having used oral corticosteroids in the last month
  • Being between the ages of 40-80
  • Body mass index being between 19-40 kg/cm2

You may not qualify if:

  • Systemic arthritis
  • Hypertensive condition that prevents exercise
  • Pregnancy, cognitive impairment, parkinson-like neurological disorders
  • Having had a knee or hip joint replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Science University

Kütahya, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled clinical trial design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 10, 2024

First Posted

February 21, 2024

Study Start

January 15, 2022

Primary Completion

January 15, 2023

Study Completion

June 15, 2023

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations