Mechanical Traction Force and Knee Joint Space

Knee Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05699733
• Other study ID #: H-2022-403
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: July 22, 2023

Study information

• Verified date: September 2023
• Source: University of Hail
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 22, 2023
• Est. primary completion date: July 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Knee Arthritis

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	University of Hail	Hail

Sponsors (1)

Lead Sponsor	Collaborator
University of Hail

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)