Knee ArthritisNCT05699733
Mechanical Traction Force and Knee Joint Space
A study testing mechanical traction for knee joint in people with Knee Arthritis, run by University of Hail at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 17 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Arthritis
- What is being tested?
- mechanical traction for knee joint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Mar 2023to 22 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy subject
- males or females
- No previous surgery in lower limbs
Who cannot join
- Diseased knee joint
- Knee osteoarthritis
- Any musculoskeletal problem in the lower extremities
- Varicose veins
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- 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
Read the 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.
- Conditions
- Knee Arthritis
- Being tested
- mechanical traction for knee joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical traction for knee jointDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Mechanical traction force 30% of body weight | Experimental | will receive continuous mechanical traction from semi flexed knee, for 30 minutes using 30% of the body weight as a traction force Receives: Device: mechanical traction for knee joint |
| Mechanical traction force 20% of body weight | Experimental | will receive continuous mechanical traction from semi flexed knee, for 30 minutes using 20% of the body weight as a traction force Receives: Device: mechanical traction for knee joint |
| Mechanical traction force 10% of body weight | Experimental | will receive continuous mechanical traction from semi flexed knee, for 30 minutes using 10 % of the body weight as a traction force Receives: Device: mechanical traction for knee joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: short term (30 minutes after the first session)
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: short term (30 minutes after the first session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Mar 2023
- Primary completion22 Jul 2023
- Study completion22 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 conducted
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hail
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Mohamed Hussein, University of Hail
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699733
- Sponsor's protocol ID
- H-2022-403
- Status last verified
- Sep 2023
- First submitted
- 8 Nov 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: it will available upon request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influences of Mechanical Traction Using Different Forces on Knee Joint Space, Range of Motion, and Hamstring Flexibility in Asymptomatic Subjects: Preliminary Study
- ClinicalTrials.gov ID
- NCT05699733
- Acronym / sponsor ID
- H-2022-403
- Conditions
- Knee Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of HailUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 22 Jul 2023 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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 conducted
| Arm | Type | Receives |
|---|---|---|
| Mechanical traction force 30% of body weight | Experimental | Device: mechanical traction for knee jointwill receive continuous mechanical traction from semi flexed knee, for 30 minutes using 30% of the body weight as a traction force |
| Mechanical traction force 20% of body weight | Experimental | Device: mechanical traction for knee jointwill receive continuous mechanical traction from semi flexed knee, for 30 minutes using 20% of the body weight as a traction force |
| Mechanical traction force 10% of body weight | Experimental | Device: mechanical traction for knee jointwill receive continuous mechanical traction from semi flexed knee, for 30 minutes using 10 % of the body weight as a traction force |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy subject
- males or females
- No previous surgery in lower limbs
Key exclusion criteria (5 listed)
- Diseased knee joint
- Knee osteoarthritis
- Any musculoskeletal problem in the lower extremities
- Varicose veins
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical traction for knee jointAll 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 | Device | Mechanical traction force 10% of body weight, Mechanical traction force 20% of body weight, Mechanical traction force 30% of body weight |
Primary outcome
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
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
4 secondary outcomes
hamstrings flexibility
Time frame: immediate (after first session)
hamstrings flexibility
Time frame: short term (30 minutes after the first session)
knee active range of motion
Time frame: immediate (after first session)
knee active range of motion
Time frame: short term (30 minutes after the first session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: Yes. it will available upon request from the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical traction for knee joint in people with Knee Arthritis, run by University of Hail at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee joint space (time frame: immediate (after first session)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.