Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-29 @ 8:28 AM
Study NCT ID:
NCT04292795
Status:
UNKNOWN
Last Update Posted:
2020-07-31
First Post:
2020-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Shortwave Diathermy and Therapeutic Ultrasound on Medial Tibial Stress Syndrome Among Military Cadets
Sponsor:
Shifa Clinical Research Center
Organization:
Study Overview
Official Title:
Effect of Shortwave Diathermy Versus Therapeutic Ultrasound on Medial Tibial Stress Syndrome Among Military Cadets
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: