Mechanical Traction Force and Knee Joint Space

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

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

Study Overview

• Status: Completed
• Conditions: Knee Arthritis
• Intervention / Treatment: Device: mechanical traction for knee joint

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Hail, Saudi Arabia, 3994
    • University of Hail

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy subject
2. males or females
3. No previous surgery in lower limbs

Exclusion Criteria:

1. Diseased knee joint
2. Knee osteoarthritis
3. Any musculoskeletal problem in the lower extremities
4. Varicose veins
5. Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mechanical traction force 30% of body weight; will receive continuous mechanical traction from semi flexed knee, for 30 minutes using 30% of the body weight as a traction force	Device: mechanical traction for knee joint; 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
Experimental: Mechanical traction force 20% of body weight; will receive continuous mechanical traction from semi flexed knee, for 30 minutes using 20% of the body weight as a traction force	Device: mechanical traction for knee joint; 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
Experimental: Mechanical traction force 10% of body weight; will receive continuous mechanical traction from semi flexed knee, for 30 minutes using 10 % of the body weight as a traction force	Device: mechanical traction for knee joint; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
knee joint space	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	immediate (after first session)
knee joint space	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	short term (30 minutes after the first session)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hamstrings flexibility	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	immediate (after first session)
hamstrings flexibility	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	short term (30 minutes after the first session)
knee active range of motion	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	immediate (after first session)
knee active range of motion	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	short term (30 minutes after the first session)

Collaborators and Investigators

• Sponsor: University of Hail

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): July 22, 2023
• Study Completion (Actual): July 22, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: H-2022-403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: it will available upon request from the principal investigator
• IPD Sharing Time Frame: 1 year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No