NCT05637476

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

November 13, 2022

Last Update Submit

January 12, 2024

Conditions

Keywords

Recreational runnersFrontal plane projection anglePelvic drop heightKinovea software

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (2)

  • Pain severity

    8 weeks

  • Lower extremity function

    8 weeks

Study Arms (2)

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.

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.

Other: Functional strength training of hip abductorsOther: A selected physical therapy exercise program

Interventions

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 .

Group B (Experimental group)

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)

Also known as: Common established treatment exercises
Group A (Active control group)Group B (Experimental group)

Eligibility Criteria

Age25 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 )

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, Egypt

Location

Related Publications (21)

  • 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.

    PMID: 17549951BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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: 10.1177/036354659502300418.

  • 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.

  • 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.

  • Lashien SA, Abdelnaeem AO, Gomaa EF. Effect of hip abductors training on pelvic drop and knee valgus in runners with medial tibial stress syndrome: a randomized controlled trial. J Orthop Surg Res. 2024 Oct 29;19(1):700. doi: 10.1186/s13018-024-05139-3.

MeSH Terms

Conditions

Medial Tibial Stress Syndrome

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesLeg InjuriesWounds and Injuries

Study Officials

  • Ebtessam F Gomaa, Doctorate

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior musculoskeletal physiotherapist ,faculty of physical therapy

Study Record Dates

First Submitted

November 13, 2022

First Posted

December 5, 2022

Study Start

December 1, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

January 16, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations