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

Medial Tibial Stress Syndrome Clinical Trial

— MTSS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05637476
• Other study ID #: Medial tibial stress syndrome
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 medial tibial stress syndrome patients.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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 )

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Medial Tibial Stress Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Egypt	Orthopedic out clinic of the faculty of Physical therapy, Cairo, University,and Gezira Youth Center.	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (20)

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. eC — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ferber R, Davis IM, Williams DS 3rd. Gender differences in lower extremity mechanics during running. Clin Biomech (Bristol, Avon). 2003 May;18(4):350-7. doi: 10.1016/s0268-0033(03)00025-1. — View Citation

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. — View Citation

Fredericson M, Bergman AG, Hoffman KL, Dillingham MS. Tibial stress reaction in runners. Correlation of clinical symptoms and scintigraphy with a new magnetic resonance imaging grading system. Am J Sports Med. 1995 Jul-Aug;23(4):472-81. doi: 10.1177/03635 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. d — View Citation

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. — View Citation

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. — View Citation

Mehta SP, Fulton A, Quach C, Thistle M, Toledo C, Evans NA. Measurement Properties of the Lower Extremity Functional Scale: A Systematic Review. J Orthop Sports Phys Ther. 2016 Mar;46(3):200-16. doi: 10.2519/jospt.2016.6165. Epub 2016 Jan 26. — View Citation

Menendez C, Batalla L, Prieto A, Rodriguez MA, Crespo I, Olmedillas H. Medial Tibial Stress Syndrome in Novice and Recreational Runners: A Systematic Review. Int J Environ Res Public Health. 2020 Oct 13;17(20):7457. doi: 10.3390/ijerph17207457. — View Citation

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. — View Citation

Skouras AZ, Kanellopoulos AK, Stasi S, Triantafyllou A, Koulouvaris P, Papagiannis G, Papathanasiou G. Clinical Significance of the Static and Dynamic Q-angle. Cureus. 2022 May 11;14(5):e24911. doi: 10.7759/cureus.24911. eCollection 2022 May. — View Citation

Willson JD, Davis IS. Utility of the frontal plane projection angle in females with patellofemoral pain. J Orthop Sports Phys Ther. 2008 Oct;38(10):606-15. doi: 10.2519/jospt.2008.2706. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline frontal plane projection angle at 8 weeks.
Primary	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.	Change from baseline contra-lateral pelvic drop angle at 8 weeks.
Secondary	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	8 weeks
Secondary	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: Extreme difficulty.; Quite a bit of difficulty.; Moderate difficulty.; A little bit of difficulty.; 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.	8 weeks