NCT04292795

Brief Summary

Medial tibial stress syndrome (MTSS) also known as shin splints or tibial periostitis is a common injury in athletes and soldiers/cadets with incidences ranging between 4% and 35% in these populations . It is characterized by pain in the middle and lower end of tibia; the pain is usually elicited by practicing sports or other physical activities. The criteria for diagnosis for MTSS were established by Yates and White. Although the prognosis of MTSS is usually benign, it can evolve to chronicity and be disabling. Several studies have demonstrated the effects of different medical treatment in athletes and cadets with MTSS. Study will correspond to the demonstration of treatment options for medial tibial stress syndrome that lie in the domain of Physical Therapy. Therapeutic Ultrasound and Shortwave Diathermy.

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
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

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

February 26, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

February 26, 2020

Last Update Submit

July 30, 2020

Conditions

Medial Tibial Stress Syndrome

Keywords

Medial Tibial Stress SyndromePainPain SyndromeCadets

Outcome Measures

Primary Outcomes (4)

  • Pre Numeric Pain Rating Scale (NPRS)

    The outcome measure suitable for evaluating the severity of pain in medial tibial stress syndrome

    the outcome will be assessed at baseline (day zero).

  • Post-Numeric Pain Rating Scale (NPRS)

    The outcome measure suitable for evaluating the severity of pain in medial tibial stress syndrome

    the outcome will be assessed at end of 4th week

  • Pre-Medial Tibial Stress Syndrome Score

    The outcome measure suitable for evaluating the severity of medial tibial stress syndrome

    the outcome will be assessed at baseline (day zero)

  • Post-Medial Tibial Stress Syndrome Score

    The outcome measure suitable for evaluating the severity of medial tibial stress syndrome

    the outcome will be assessed after the 4 weeks.

Study Arms (2)

Group A

EXPERIMENTAL

Intervention: Shortwave Diathermy Frequency: 27.12 MHz Time Duration: 10min Duration of Treatment: 4 weeks. Sessions per Week: 2 sessions per week

Device: Short wave diathermy

Group B

EXPERIMENTAL

Intervention: Therapeutic Ultrasound Frequency: 1-3MHz Intensity: 0.2-1W/cm2 Time Duration: 10mins Duration of Treatment: 4 weeks Sessions per Week: 2 sessions per week

Device: Therapeutic Ultrasound

Interventions

Therapeutic UltrasoundDEVICE

The Intervention will be provided according to the set protocols used in previous literature.

Group B
Short wave diathermyDEVICE

The Intervention will be provided according to the set protocols used in previous literature.

Group A

Eligibility Criteria

Age19 Years - 24 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 19-24 years
  • Gender: Male
  • Cadets diagnosed with Medial tibial stress syndrome according to Yates and White Criteria(3).

You may not qualify if:

  • Individuals having stress fractures or history of stress fractures.
  • Local infection or osteomyelitis.
  • Tumor in assessment region.
  • Compartment syndrome.
  • Musculoskeletal problems or other comorbidities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Academy

Abbottābād, KPK, Pakistan

Location

Related Publications (1)

  • Yates B, White S. The incidence and risk factors in the development of medial tibial stress syndrome among naval recruits. Am J Sports Med. 2004 Apr-May;32(3):772-80. doi: 10.1177/0095399703258776.

    PMID: 15090396RESULT

MeSH Terms

Conditions

Medial Tibial Stress SyndromePainSomatoform Disorders

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesLeg InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeutics

Study Officials

  • Tahir Ramzan

    Shifa Tameer-e-Millat University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tahir Ramzan, DPT

CONTACT

923015515598drtahirramzan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 3, 2020

Study Start

November 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

July 31, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)