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Completed

NCT Number: NCT05699733

Mechanical Traction Force and Knee Joint Space

the purposes of this crossover study are to Purpose

1. To determine the most effective traction force for knee joint that can be used in the treatment of patients with KOA. 2. To determine the influence of knee joint traction on ROM ok knee joint flexion and extension 3. To determine the influence of knee joint traction on the flexibility of hamstring muscles

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Key information

Conditions

Knee Arthritis

Age range

17 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hail

Ha'il, 3994, Saudi Arabia

About this study

this study is a pilot study design aiming to determine the most effective mechanical traction force used for knee joint treatment. this effectiveness was assessed in favor of the separation of the joint surfaces in cm in addition to the hamstring flexibility measured in cm and active knee flexion range of motion.

according to previous literature, there is no consensus regarding the most appropriate traction force that can produce statistical and clinically meaningful differences so we started this pilot study.

the results of this study will be used to conduct a larger-scale study using the most appropriate traction force on patients having knee osteoarthritis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subject
  • males or females
  • No previous surgery in lower limbs

Exclusion criteria

  • Diseased knee joint
  • Knee osteoarthritis
  • Any musculoskeletal problem in the lower extremities
  • Varicose veins
  • Pregnancy

Treatment and study plan

mechanical traction for knee joint

Device

All participants will receive a single session per condition. This session will consist of continuous mechanical knee traction for 30 minutes while the participant assumes a supine position with the treated limb in semiflexion (30° of flexion). the treated limb will be supported using the traction bed's table that is used for this purpose. The knee position angle will be measured by a standard goniometer. Pelvis and thigh straps will be used to fix the body and prevent slippage during the application of the traction force. A customized leg cuff will be placed around the lower leg (above the ankle joint), and a traction rope will be extending horizontally from the cuff to the traction device. 48 hours of washing out will separate the sessions of different conditions

Primary outcomes

  1. knee joint space

    Time frame: immediate (after first session)

    the distance in millimeters will be measured between the articilar acriliges of femur and tibia in non-weight bearing position from the medial and lateral aspects of the knee joint using ultrasonography device designed to assess musculoskeletal conditions

  2. knee joint space

    Time frame: short term (30 minutes after the first session)

    the distance in millimeters will be measured between the articilar acriliges of femur and tibia in non-weight bearing position from the medial and lateral aspects of the knee joint using ultrasonography device designed to assess musculoskeletal conditions

Secondary outcomes

  1. hamstrings flexibility

    Time frame: immediate (after first session)

    using the Sit and reach test: The Sit and reach test is one of the linear flexibility tests which helps to measure the extensibility of the hamstrings and lower back. it is also a field test which is easy to administer in a community setting with a large scale of population size

  2. hamstrings flexibility

    Time frame: short term (30 minutes after the first session)

    using the Sit and reach test: The Sit and reach test is one of the linear flexibility tests which helps to measure the extensibility of the hamstrings and lower back. it is also a field test which is easy to administer in a community setting with a large scale of population size

  3. knee active range of motion

    Time frame: immediate (after first session)

    Bubble inclinometer will be used to assess the active knee joint flexion range. Participant will assume supine position and after proper placement of the goniometer, she will be asked to bend her knee and hip joints as much as possible

  4. knee active range of motion

    Time frame: short term (30 minutes after the first session)

    Bubble inclinometer will be used to assess the active knee joint flexion range. Participant will assume supine position and after proper placement of the goniometer, she will be asked to bend her knee and hip joints as much as possible

Sponsors and collaborators

Lead sponsor

University of Hail

Other

Registry information

Official study title

Influences of Mechanical Traction Using Different Forces on Knee Joint Space, Range of Motion, and Hamstring Flexibility in Asymptomatic Subjects: Preliminary Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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