Effect of Shortwave Diathermy and Therapeutic Ultrasound on Medial Tibial Stress Syndrome Among Military Cadets

Effect of Shortwave Diathermy Versus Therapeutic Ultrasound on Medial Tibial Stress Syndrome Among Military Cadets

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.

Study Overview

• Status: Unknown
• Conditions: Medial Tibial Stress Syndrome
• Intervention / Treatment: Device: Short wave diathermy; Device: Therapeutic Ultrasound

Detailed Description

Primary objective of the study includes:

1. To determine the effect of Shortwave Diathermy on Medial Tibial Stress Syndrome among military cadets.
2. To determine the effect of Therapeutic Ultrasound on Medial Tibial Stress Syndrome among military cadets.
3. To compare the effects of Shortwave Diathermy and Therapeutic Ultrasound on Medial Tibial Stress Syndrome among military cadets.

study hypothesis is "Shortwave diathermy and Therapeutic Ultrasound are equally effective in Medial Tibial Stress Syndrome among military cadets.".

Study Design : Randomized Control trial Study Settings is Pakistan Military Academy Abbottabad. Sample Size: The sample size calculation is done through epitool to obtain a sample size ratio 1:1 for both treatment groups with Power of 0.8, Confidence interval of 0.95 and Variance = 5.

Mean of experimental group was 2.17 and mean of control group was 4.26 taken from the parent article.

Results obtained from epitool:

Total sample size: 36 Sample size per group: 18(each group) Sampling Technique: Non-probability Purposive Sampling- subjects will be recurited into the groups through sealed enveloped method.

Work Plan/Timeline for Participants:

Timeline for the participants will be one month after the approval of IRB form.

Follow ups:

There will be 2 follow ups per week for a period of 4 weeks.

Statistical Analysis:

Data will be analyzed on Statistical Package for Social Sciences (SPSS) version 21.

Descriptive Results:

• Quantitative data will be interpreted in terms of means and standard deviation whereas qualitative data will be presented in the form of frequencies and percentages.
• Quantitative data will be represented in form of histogram whereas qualitative data is shown in the form of bar charts and graphs.

Interferential Results:

• Data will be assessed for its normality by applying Shapiro-Wilk test and its value of 0.05 or lesser than that shows that the data is normally distributed at baseline and at the end of treatment.
• Parametric test will be used for normally distributed data whereas non parametric test would be applied for skewed sample or away from normality data.
• For comparison between two groups, Independent T Test (parametric) or Mann-Whitney Test(non-parametric) will be used both a baseline and at the end of sessions.
• For within the group comparison at intervals (baseline and post treatment), Pared T test (parametric) or Wilcoxon Rank Test (non-parametric) will be applied.

ADVERSE/SERIOUS ADVERSE EFFECTS / POTENTIAL HAZARDS:

No adverse effects are present in this study. Onsite clinical arrangements will be made available for subjective and objective assessment and for the treatment protocol as well. For this purpose portable modalities will be used which will be easy to transfer and operate. The total expenses required will be provided by the students themselves

No potential risk present to the participants or community as a whole

POTENTIAL BENEFIT TO THE PARTICIPANTS OR COMMUNITY AS WHOLE

1. Awareness will be provided regarding MTSS among community.
2. Long term complications leading to physical limitations and disability will be prevented.
3. Awareness regarding Physical Therapy treatment for MTSS will be provided

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tahir Ramzan, DPT; Phone Number: 923015515598; Email: drtahirramzan@gmail.com

Study Locations

• Pakistan
  • KPK
    • Abbottābād, KPK, Pakistan
      • Military Academy
      • Contact: IRB Shifa; Phone Number: 0092518463075; Email: irbshifa@shifa.com.pk
      • Contact: Dr. Tahir Ramzan, DPT, MS-CPPT; Phone Number: 03015515598

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 24 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Individuals having stress fractures or history of stress fractures.
2. Local infection or osteomyelitis.
3. Tumor in assessment region.
4. Compartment syndrome.
5. Musculoskeletal problems or other comorbidities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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; The Intervention will be provided according to the set protocols used in previous literature.
Experimental: Group B; 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; The Intervention will be provided according to the set protocols used in previous literature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Shifa Clinical Research Center
• Investigators: Principal Investigator: Tahir Ramzan, Shifa Tameer-e-Millat University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: March 1, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Medial Tibial Stress Syndrome; Pain Syndrome; Cadets
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Leg Injuries; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Medial Tibial Stress Syndrome
• Other Study ID Numbers: Applied_for_IRB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No