Medial Tibial Stress SyndromeMTSSNCT05637476

Effect of Functional Strength Training of Hip Abductors in Runners With Medial Tibial Stress Syndrome

A study testing Functional strength training of hip abductors and A selected physical therapy exercise program in people with Medial Tibial Stress Syndrome, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study will be the first project to investigate the effect of functional strength training of hip abductors on pain, function, hip, and knee kinematics including contra-lateral pelvic drop angle (hip frontal plane projection angle) and dynamic knee valgus (knee frontal plane projection angle) in runners with… Read more about this study

Who is it for?: Ages 25 to 35 years
Conditions the study is for: Medial Tibial Stress Syndrome
What is being tested?: Functional strength training of hip abductors and A selected physical therapy exercise program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteEgypt
Study dates: 1 Dec 2022to 30 Jun 2024
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 25 to 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male and female Athletes (runners) with a referred diagnosis of MTSS for at least 1 month
Participants with bilateral affection, the most affected limb will be included in measurements.
Body mass index range between (18.5-25 kg /m2 )

Who cannot join

History of previous lower extremity surgery
Neurological problems that will affect lower extremity function
Recent or old fractures at lower limbs
Cognitive impairment
Medications (anti-inflammatory/muscle relaxant)
Tumours

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Orthopedic out clinic of the faculty of Physical therapy, Cairo, University,and Gezira Youth Center.
Cairo

Other trials in Egypt

About this study

Official title: Effect of Functional Strength Training of Hip Abductors in Runners With Medial Tibial Stress :(Randomised Clinical Trail)

Read the detailed description

Forty participants with medial tibial stress syndrome will be recruited from orthopedic out clinic of the faculty of Physical therapy, Cairo, University, and Gezira Youth Center. They will be asked to sign the informed consent form .

The selected participants will be randomly assigned to two groups using a simple randomization method to allocate participants to the groups through the available online website www.randomization.com considering the control group as active control group. A flow diagram according to the Consolidated Standards of Reporting Trials (CONSORT) statement will be presented to illustrate the progression of this clinical trial .

Sample size calculation was performed using G*POWER statistical software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) based on data of knee valgus angle derived from Pourahmad et al., (2021) who investigated the effect of strengthening the abductor and external rotator on lower limb kinematics in volleyball players with patellofemoral complications. The sample size required for this study was approximately 15 subjects in each group. Calculation is made with α=0.05, power = 80% and effect size = 1.1. The sample size increased to 18 subjects per group for possible dropout of 20%.

For statistical analysis:

Unpaired t-test will be conducted for comparison of the subject characteristics between groups.
Chi- squared test will be conducted for comparison of sex distribution between groups.
Mixed MANOVA will be conducted to investigate the effect of treatment on pain, function, contralateral pelvic drop angle and dynamic knee valgus.
Post-hoc tests using the Bonferroni test were carried out for subsequent multiple comparison.
Statistical measures will be performed through the statistical package for social studies (SPSS) version 25 for windows.
The level of significance for all statistical tests will be set at p < 0.05.

Conditions: Medial Tibial Stress Syndrome
Being tested: Functional strength training of hip abductors, A selected physical therapy exercise program
Keywords: Recreational runners, Frontal plane projection angle, Pelvic drop height, Kinovea software
Medical subject headings: Medial Tibial Stress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Functional strength training of hip abductorsOther
Every participant will perform three sets of fifteen repetitions, fifteen seconds rest in between, three times per week for the following exercises:
1. Pelvic drop.
2. Single leg -bridge.
3. Side-lying hip abduction with hip internal rotation.
4. Lateral step-up.
5. Standing hip abduction on stance or swing leg with extra resistance .
A selected physical therapy exercise programOther
Also called Common established treatment exercises
Every participant will perform three sets of fifteen repetitions, fifteen seconds rest in between, three times per week for the following exercises:
1. Strength dorsiflexors of the ankle-using rubber band.
2. Eccentric calf exercise (calf raise) .
3. Balance and proprioceptive exercise using wobble boards.
4. Stretch planter flexors (three sets of thirty repetitions, thirty seconds rest in between, three times per week)

Study groups in NCT05637476
Study group	Role	What they receive
Group A (Active control group)	Active comparator	Group A (number=20): which is the control group with medial tibial stress syndrome, they will receive a selected physical therapy exercise program. Receives: Other: A selected physical therapy exercise program
Group B (Experimental group)	Experimental	Group B (number=20): which is the experimental group with Medial tibial stress syndrome, they will receive the same physical therapy exercise program as group A in addition to, functional strength training of hip abductors. Receives: Other: Functional strength training of hip abductors; Other: A selected physical therapy exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

The Frontal Plane Projection Angle
It is a measure of the degree of dynamic knee valgus during functional tasks. FPPA is an angle that consists of two lines. One line between the thigh and hip markers and the other line between the ankle and knee markers .So that,from a frontal view, when the knee marker is medial to a line from the ankle marker to the thigh marker,the FPPA is negative (knee valgus).While,The FPPA is positive if the knee marker is lateral to a line drawn from ankle marker to the thigh marker (knee varus).
Measured: Change from baseline frontal plane projection angle at 8 weeks.
The contra-lateral pelvic drop angle
It is determined as the angle subtended by one line connecting the anterior superior iliac spine with the stance and swing limb and a second line drawn perpendicular to the stance limb anterior superior iliac spine then, the measurement will be subtracted from 90 degrees.
Measured: Change from baseline contra-lateral pelvic drop angle at 8 weeks.

Secondary outcomes (2)

Pain severity
Through using the visual analogue scale to detect the change from the baseline pain severity at eight weeks exercises treatment program. The participant will be asked to assess the worst pain level experience at last three days. The pain visual analogue scale is a uni-dimensional measure of pain severity,a straight horizontal line of fixed length,usually 10 cm.Using a ruler, the score is determined by measuring the distance (mm)on the 10-cm line between the no pain anchor and the patient's mark,providing a range of scores from 0-100. A higher score indicates greater pain intensity,while a lower score indicates lesser pain
Measured: 8 weeks
Lower extremity function
Through using the lower extremity functional scale to detect the change from the baseline lower extremity function at eight weeks exercises treatment program.It is a self-report questionnaire.Twenty questions that assesses a person's capacity doing twenty different everyday activities.Patients select an answer from the following scale for each activity listed:
1. Extreme difficulty.
2. Quite a bit of difficulty.
3. Moderate difficulty.
4. A little bit of difficulty.
5. No difficulty.
Scoring guidelines to determine the final score,the scale's columns are added together, thus, the maximum possible score is 80 points, indicating very high function. The minimum possible score is 0 points, indicating very low function.While 9 scale points are the smallest difference that may be seen and the smallest variation that is clinically significant.Percentage of maximum function=(lower extermity function scale score)/80*100.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202230 Jun 2024

First posted5 Dec 2022
Study start1 Dec 2022
Primary completion30 Jun 2024 (estimated)
Study completion30 Jun 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Medial Tibial Stress SyndromeStudies of the same condition, open and under way.
More trials run by Cairo UniversityThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05637476
Sponsor's protocol ID: Medial tibial stress syndrome
Acronym: MTSS
Status last verified: Jan 2024
First submitted: 13 Nov 2022
Last updated: 16 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Robinson RL, Nee RJ. Analysis of hip strength in females seeking physical therapy treatment for unilateral patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2007 May;37(5):232-8. doi: 10.2519/jospt.2007.2439.
PubMed 17549951
Irawan DS, Huoth C, Sinsurin K, Kiratisin P, Vachalathiti R, Richards J. Concurrent Validity and Reliability of Two-dimensional Frontal Plane Knee Measurements during Multi-directional Cutting Maneuvers. Int J Sports Phys Ther. 2022 Feb 2;17(2):148-155. doi: 10.26603/001c.31651. eCollection 2022.
PubMed 35136683
Almeida GP, Silva AP, Franca FJ, Magalhaes MO, Burke TN, Marques AP. Q-angle in patellofemoral pain: relationship with dynamic knee valgus, hip abductor torque, pain and function. Rev Bras Ortop. 2016 Feb 9;51(2):181-6. doi: 10.1016/j.rboe.2016.01.010. eCollection 2016 Mar-Apr.
PubMed 27069887
Cashman GE. The effect of weak hip abductors or external rotators on knee valgus kinematics in healthy subjects: a systematic review. J Sport Rehabil. 2012 Aug;21(3):273-84. doi: 10.1123/jsr.21.3.273.
PubMed 22894982
Chuter VH, Janse de Jonge XA. Proximal and distal contributions to lower extremity injury: a review of the literature. Gait Posture. 2012 May;36(1):7-15. doi: 10.1016/j.gaitpost.2012.02.001. Epub 2012 Mar 21.
PubMed 22440758
Cichanowski HR, Schmitt JS, Johnson RJ, Niemuth PE. Hip strength in collegiate female athletes with patellofemoral pain. Med Sci Sports Exerc. 2007 Aug;39(8):1227-32. doi: 10.1249/mss.0b013e3180601109.
PubMed 17762354
Craig DI. Medial tibial stress syndrome: evidence-based prevention. J Athl Train. 2008 May-Jun;43(3):316-8. doi: 10.4085/1062-6050-43.3.316.
PubMed 18523568
Dierks TA, Manal KT, Hamill J, Davis IS. Proximal and distal influences on hip and knee kinematics in runners with patellofemoral pain during a prolonged run. J Orthop Sports Phys Ther. 2008 Aug;38(8):448-56. doi: 10.2519/jospt.2008.2490. Epub 2008 Aug 1.
PubMed 18678957
Ferber R, Davis IM, Williams DS 3rd. Gender differences in lower extremity mechanics during running. Clin Biomech (Bristol). 2003 May;18(4):350-7. doi: 10.1016/s0268-0033(03)00025-1.
PubMed 12689785
Franklyn M, Oakes B. Aetiology and mechanisms of injury in medial tibial stress syndrome: Current and future developments. World J Orthop. 2015 Sep 18;6(8):577-89. doi: 10.5312/wjo.v6.i8.577. eCollection 2015 Sep 18.
PubMed 26396934
Galbraith RM, Lavallee ME. Medial tibial stress syndrome: conservative treatment options. Curr Rev Musculoskelet Med. 2009 Oct 7;2(3):127-33. doi: 10.1007/s12178-009-9055-6.
PubMed 19809896
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
PubMed 22588748
Hreljac A, Marshall RN, Hume PA. Evaluation of lower extremity overuse injury potential in runners. Med Sci Sports Exerc. 2000 Sep;32(9):1635-41. doi: 10.1097/00005768-200009000-00018.
PubMed 10994917
Ireland ML, Willson JD, Ballantyne BT, Davis IM. Hip strength in females with and without patellofemoral pain. J Orthop Sports Phys Ther. 2003 Nov;33(11):671-6. doi: 10.2519/jospt.2003.33.11.671.
PubMed 14669962
Leetun DT, Ireland ML, Willson JD, Ballantyne BT, Davis IM. Core stability measures as risk factors for lower extremity injury in athletes. Med Sci Sports Exerc. 2004 Jun;36(6):926-34. doi: 10.1249/01.mss.0000128145.75199.c3.
PubMed 15179160

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Functional Strength Training of Hip Abductors in Runners With Medial Tibial Stress :(Randomised Clinical Trail)
ClinicalTrials.gov ID: NCT05637476
Acronym / sponsor ID: MTSS / Medial tibial stress syndrome
Conditions: Medial Tibial Stress Syndrome
Keywords: Recreational runners, Frontal plane projection angle, Pelvic drop height, Kinovea software
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (actual)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Study start: 1 Dec 2022 (actual)
Primary completion: 30 Jun 2024 (estimated)
Study completion: 30 Jun 2024 (estimated)
First posted: 5 Dec 2022 (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.

Detailed description

For statistical analysis:

Unpaired t-test will be conducted for comparison of the subject characteristics between groups.
Chi- squared test will be conducted for comparison of sex distribution between groups.
Mixed MANOVA will be conducted to investigate the effect of treatment on pain, function, contralateral pelvic drop angle and dynamic knee valgus.
Post-hoc tests using the Bonferroni test were carried out for subsequent multiple comparison.
Statistical measures will be performed through the statistical package for social studies (SPSS) version 25 for windows.
The level of significance for all statistical tests will be set at p < 0.05.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Group A (Active control group)	Active comparator	Other: A selected physical therapy exercise programGroup A (number=20): which is the control group with medial tibial stress syndrome, they will receive a selected physical therapy exercise program.
Group B (Experimental group)	Experimental	Other: Functional strength training of hip abductors, Other: A selected physical therapy exercise programGroup B (number=20): which is the experimental group with Medial tibial stress syndrome, they will receive the same physical therapy exercise program as group A in addition to, functional strength training of hip abductors.

Who may qualify

Ages: 25 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Male and female Athletes (runners) with a referred diagnosis of MTSS for at least 1 month
Participants with bilateral affection, the most affected limb will be included in measurements.
Body mass index range between (18.5-25 kg /m2 )

Key exclusion criteria (6 listed)

History of previous lower extremity surgery
Neurological problems that will affect lower extremity function
Recent or old fractures at lower limbs
Cognitive impairment
Medications (anti-inflammatory/muscle relaxant)

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
Functional strength training of hip abductorsEvery participant will perform three sets of fifteen repetitions, fifteen seconds rest in between, three times per week for the following exercises: 1. Pelvic drop. 2. Single leg -bridge. 3. Side-lying hip abduction with hip internal rotation. 4. Lateral step-up. 5. Standing hip abduction on stance or swing leg with extra resistance .	Other	Group B (Experimental group)
A selected physical therapy exercise programAlso: Common established treatment exercisesEvery participant will perform three sets of fifteen repetitions, fifteen seconds rest in between, three times per week for the following exercises: 1. Strength dorsiflexors of the ankle-using rubber band. 2. Eccentric calf exercise (calf raise) . 3. Balance and proprioceptive exercise using wobble boards. 4. Stretch planter flexors (three sets of thirty repetitions, thirty seconds rest in between, three times per week)	Other	Group A (Active control group), Group B (Experimental group)

Primary outcome

The Frontal Plane Projection Angle
Time frame: Change from baseline frontal plane projection angle at 8 weeks.
It is a measure of the degree of dynamic knee valgus during functional tasks. FPPA is an angle that consists of two lines. One line between the thigh and hip markers and the other line between the ankle and knee markers .So that,from a frontal view, when the knee marker is medial to a line from the ankle marker to the thigh marker,the FPPA is negative (knee valgus).While,The FPPA is positive if the knee marker is lateral to a line drawn from ankle marker to the thigh marker (knee varus).
The contra-lateral pelvic drop angle
Time frame: Change from baseline contra-lateral pelvic drop angle at 8 weeks.
It is determined as the angle subtended by one line connecting the anterior superior iliac spine with the stance and swing limb and a second line drawn perpendicular to the stance limb anterior superior iliac spine then, the measurement will be subtracted from 90 degrees.

2 secondary outcomes

Pain severity
Time frame: 8 weeks
Lower extremity function
Time frame: 8 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
Background: PubMed 17549951Robinson RL, Nee RJ. Analysis of hip strength in females seeking physical therapy treatment for unilateral patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2007 May;37(5):232-8. doi: 10.2519/jospt.2007.2439.
Results publication: PubMed 35136683Irawan DS, Huoth C, Sinsurin K, Kiratisin P, Vachalathiti R, Richards J. Concurrent Validity and Reliability of Two-dimensional Frontal Plane Knee Measurements during Multi-directional Cutting Maneuvers. Int J Sports Phys Ther. 2022 Feb 2;17(2):148-155. doi: 10.26603/001c.31651. eCollection 2022.
Results publication: PubMed 27069887Almeida GP, Silva AP, Franca FJ, Magalhaes MO, Burke TN, Marques AP. Q-angle in patellofemoral pain: relationship with dynamic knee valgus, hip abductor torque, pain and function. Rev Bras Ortop. 2016 Feb 9;51(2):181-6. doi: 10.1016/j.rboe.2016.01.010. eCollection 2016 Mar-Apr.
Results publication: PubMed 22894982Cashman GE. The effect of weak hip abductors or external rotators on knee valgus kinematics in healthy subjects: a systematic review. J Sport Rehabil. 2012 Aug;21(3):273-84. doi: 10.1123/jsr.21.3.273.
Results publication: PubMed 22440758Chuter VH, Janse de Jonge XA. Proximal and distal contributions to lower extremity injury: a review of the literature. Gait Posture. 2012 May;36(1):7-15. doi: 10.1016/j.gaitpost.2012.02.001. Epub 2012 Mar 21.
Results publication: PubMed 17762354Cichanowski HR, Schmitt JS, Johnson RJ, Niemuth PE. Hip strength in collegiate female athletes with patellofemoral pain. Med Sci Sports Exerc. 2007 Aug;39(8):1227-32. doi: 10.1249/mss.0b013e3180601109.
Results publication: PubMed 18523568Craig DI. Medial tibial stress syndrome: evidence-based prevention. J Athl Train. 2008 May-Jun;43(3):316-8. doi: 10.4085/1062-6050-43.3.316.
Results publication: PubMed 18678957Dierks TA, Manal KT, Hamill J, Davis IS. Proximal and distal influences on hip and knee kinematics in runners with patellofemoral pain during a prolonged run. J Orthop Sports Phys Ther. 2008 Aug;38(8):448-56. doi: 10.2519/jospt.2008.2490. Epub 2008 Aug 1.
Results publication: PubMed 12689785Ferber R, Davis IM, Williams DS 3rd. Gender differences in lower extremity mechanics during running. Clin Biomech (Bristol). 2003 May;18(4):350-7. doi: 10.1016/s0268-0033(03)00025-1.
Results publication: PubMed 26396934Franklyn M, Oakes B. Aetiology and mechanisms of injury in medial tibial stress syndrome: Current and future developments. World J Orthop. 2015 Sep 18;6(8):577-89. doi: 10.5312/wjo.v6.i8.577. eCollection 2015 Sep 18.
Results publication: PubMed 19809896Galbraith RM, Lavallee ME. Medial tibial stress syndrome: conservative treatment options. Curr Rev Musculoskelet Med. 2009 Oct 7;2(3):127-33. doi: 10.1007/s12178-009-9055-6.
Results publication: PubMed 22588748Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
Individual participant dataSharing planned: No

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.

Ebtessam F Gomaa, Doctorate study chair

Cairo University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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: status not confirmed, as of the sponsor's last update on 16 Jan 2024. 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 Egypt. 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?

Results are not available in the source record.

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?

The Frontal Plane Projection Angle (time frame: Change from baseline frontal plane projection angle at 8 weeks.). 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?

On the ClinicalTrials.gov record for NCT05637476, which also lists 21 linked publications.

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 16 Jan 2024.