Mechanical Traction Force and Knee Joint Space

Sponsor

University of Hail (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05699733

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

the purposes of this crossover study are to Purpose

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

Condition or Disease	Intervention/Treatment	Phase
Knee Arthritis	Device: mechanical traction for knee joint	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

the recruited sample will be subjected to 3 treatment conditions according to the traction force used. pre-post comparisons and between conditions comparisons will be conductedthe recruited sample will be subjected to 3 treatment conditions according to the traction force used. pre-post comparisons and between conditions comparisons will be conducted

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 30, 2023

Anticipated Study Completion Date :

May 30, 2023

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

knee joint space [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
knee joint space [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 Outcome Measures

hamstrings flexibility [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
hamstrings flexibility [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
knee active range of motion [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
knee active range of motion [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Hail	Hail		Saudi Arabia	3994

Sponsors and Collaborators

University of Hail

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hisham Mohamed Hussein, assistant professor, University of Hail

ClinicalTrials.gov Identifier:

NCT05699733

Other Study ID Numbers:

H-2022-403

First Posted:

Jan 26, 2023

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Study Results

No Results Posted as of Jan 26, 2023