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

Primary Purpose

Medial Tibial Stress Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Therapeutic Ultrasound
Short wave diathermy
Sponsored by
Shifa Clinical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medial Tibial Stress Syndrome focused on measuring Medial Tibial Stress Syndrome, Pain, Pain Syndrome, Cadets

Eligibility Criteria

19 Years - 24 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Military Academy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pre Numeric Pain Rating Scale (NPRS)
The outcome measure suitable for evaluating the severity of pain in medial tibial stress syndrome
Post-Numeric Pain Rating Scale (NPRS)
The outcome measure suitable for evaluating the severity of pain in medial tibial stress syndrome
Pre-Medial Tibial Stress Syndrome Score
The outcome measure suitable for evaluating the severity of medial tibial stress syndrome
Post-Medial Tibial Stress Syndrome Score
The outcome measure suitable for evaluating the severity of medial tibial stress syndrome

Secondary Outcome Measures

Full Information

First Posted
February 26, 2020
Last Updated
July 30, 2020
Sponsor
Shifa Clinical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT04292795
Brief Title
Effect of Shortwave Diathermy and Therapeutic Ultrasound on Medial Tibial Stress Syndrome Among Military Cadets
Official Title
Effect of Shortwave Diathermy Versus Therapeutic Ultrasound on Medial Tibial Stress Syndrome Among Military Cadets
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
February 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shifa Clinical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Primary objective of the study includes: To determine the effect of Shortwave Diathermy on Medial Tibial Stress Syndrome among military cadets. To determine the effect of Therapeutic Ultrasound on Medial Tibial Stress Syndrome among military cadets. 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 Awareness will be provided regarding MTSS among community. Long term complications leading to physical limitations and disability will be prevented. Awareness regarding Physical Therapy treatment for MTSS will be provided

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medial Tibial Stress Syndrome
Keywords
Medial Tibial Stress Syndrome, Pain, Pain Syndrome, Cadets

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Intervention: Shortwave Diathermy Frequency: 27.12 MHz Time Duration: 10min Duration of Treatment: 4 weeks. Sessions per Week: 2 sessions per week
Arm Title
Group B
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Therapeutic Ultrasound
Intervention Description
The Intervention will be provided according to the set protocols used in previous literature.
Intervention Type
Device
Intervention Name(s)
Short wave diathermy
Intervention Description
The Intervention will be provided according to the set protocols used in previous literature.
Primary Outcome Measure Information:
Title
Pre Numeric Pain Rating Scale (NPRS)
Description
The outcome measure suitable for evaluating the severity of pain in medial tibial stress syndrome
Time Frame
the outcome will be assessed at baseline (day zero).
Title
Post-Numeric Pain Rating Scale (NPRS)
Description
The outcome measure suitable for evaluating the severity of pain in medial tibial stress syndrome
Time Frame
the outcome will be assessed at end of 4th week
Title
Pre-Medial Tibial Stress Syndrome Score
Description
The outcome measure suitable for evaluating the severity of medial tibial stress syndrome
Time Frame
the outcome will be assessed at baseline (day zero)
Title
Post-Medial Tibial Stress Syndrome Score
Description
The outcome measure suitable for evaluating the severity of medial tibial stress syndrome
Time Frame
the outcome will be assessed after the 4 weeks.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 19-24 years Gender: Male Cadets diagnosed with Medial tibial stress syndrome according to Yates and White Criteria(3). Exclusion Criteria: Individuals having stress fractures or history of stress fractures. Local infection or osteomyelitis. Tumor in assessment region. Compartment syndrome. Musculoskeletal problems or other comorbidities.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tahir Ramzan, DPT
Phone
923015515598
Email
drtahirramzan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tahir Ramzan
Organizational Affiliation
Shifa Tameer-e-Millat University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Military Academy
City
Abbottābād
State/Province
KPK
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IRB Shifa
Phone
0092518463075
Email
irbshifa@shifa.com.pk
First Name & Middle Initial & Last Name & Degree
Dr. Tahir Ramzan, DPT, MS-CPPT
Phone
03015515598

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15090396
Citation
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.
Results Reference
result

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

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