Medial Tibial Stress SyndromeNCT04292795
Effect of Shortwave Diathermy and Therapeutic Ultrasound on Medial Tibial Stress Syndrome Among Military Cadets
A study testing Therapeutic Ultrasound and Short wave diathermy in people with Medial Tibial Stress Syndrome, run by Shifa Clinical Research Center at 1 site in Pakistan.
Trial 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 . Read more about this study
- Who is it for?
- Ages 19 to 24 years, men only
- Conditions the study is for
- Medial Tibial Stress Syndrome
- What is being tested?
- Therapeutic Ultrasound and Short wave diathermy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2020to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 24 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 19-24 years
- Gender: Male
- Cadets diagnosed with Medial tibial stress syndrome according to Yates and White Criteria(3).
Who cannot join
- Individuals having stress fractures or history of stress fractures.
- Local infection or osteomyelitis.
- Tumor in assessment region.
- Compartment syndrome.
- Musculoskeletal problems or other comorbidities.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Military Academy
Abbottābād, KPK
IRB Shifa, 0092518463075, irbshifa@shifa.com.pk
Dr. Tahir Ramzan, DPT, MS-CPPT, 03015515598
About this study
Official title: 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.
Read the 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
- Conditions
- Medial Tibial Stress Syndrome
- Being tested
- Therapeutic Ultrasound, Short wave diathermy
- Keywords
- Medial Tibial Stress Syndrome, Pain, Pain Syndrome, Cadets
- Medical subject headings
- Medial Tibial Stress Syndrome, Pain, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic UltrasoundDevice
The Intervention will be provided according to the set protocols used in previous literature.
Short wave diathermyDevice
The Intervention will be provided according to the set protocols used in previous literature.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Therapeutic Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre Numeric Pain Rating Scale (NPRS)
The outcome measure suitable for evaluating the severity of pain in medial tibial stress syndrome
Measured: 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
Measured: 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
Measured: 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
Measured: the outcome will be assessed after the 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medial Tibial Stress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa Clinical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tahir Ramzan, Shifa Clinical Research Center
- Investigators
- Tahir Ramzan, Principal investigator, Shifa Tameer-e-Millat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292795
- Sponsor's protocol ID
- Applied_for_IRB
- Status last verified
- Jul 2020
- First submitted
- 26 Feb 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15090396
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shortwave Diathermy Versus Therapeutic Ultrasound on Medial Tibial Stress Syndrome Among Military Cadets
- ClinicalTrials.gov ID
- NCT04292795
- Acronym / sponsor ID
- Applied_for_IRB
- Conditions
- Medial Tibial Stress Syndrome
- Keywords
- Medial Tibial Stress Syndrome, Pain, Pain Syndrome, Cadets
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shifa Clinical Research CenterUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Short wave diathermyIntervention: Shortwave Diathermy Frequency: 27.12 MHz Time Duration: 10min Duration of Treatment: 4 weeks. Sessions per Week: 2 sessions per week |
| Group B | Experimental | Device: Therapeutic UltrasoundIntervention: 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 |
Who may qualify
- Ages
- 19 to 24 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 19-24 years
- Gender: Male
- Cadets diagnosed with Medial tibial stress syndrome according to Yates and White Criteria(3).
Key exclusion criteria (5 listed)
- Individuals having stress fractures or history of stress fractures.
- Local infection or osteomyelitis.
- Tumor in assessment region.
- Compartment syndrome.
- Musculoskeletal problems or other comorbidities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic UltrasoundThe Intervention will be provided according to the set protocols used in previous literature. | Device | Group B |
| Short wave diathermyThe Intervention will be provided according to the set protocols used in previous literature. | Device | Group A |
Primary outcome
Pre Numeric Pain Rating Scale (NPRS)
Time frame: the outcome will be assessed at baseline (day zero).
The outcome measure suitable for evaluating the severity of pain in medial tibial stress syndrome
Post-Numeric Pain Rating Scale (NPRS)
Time frame: the outcome will be assessed at end of 4th week
The outcome measure suitable for evaluating the severity of pain in medial tibial stress syndrome
Pre-Medial Tibial Stress Syndrome Score
Time frame: the outcome will be assessed at baseline (day zero)
The outcome measure suitable for evaluating the severity of medial tibial stress syndrome
Post-Medial Tibial Stress Syndrome Score
Time frame: the outcome will be assessed after the 4 weeks.
The outcome measure suitable for evaluating the severity of medial tibial stress syndrome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Results publication: PubMed 15090396Yates 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tahir Ramzan principal investigator
Shifa Tameer-e-Millat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Ultrasound and Short wave diathermy in people with Medial Tibial Stress Syndrome, run by Shifa Clinical Research Center at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tahir Ramzan, DPT (923015515598, drtahirramzan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre Numeric Pain Rating Scale (NPRS) (time frame: the outcome will be assessed at baseline (day zero).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04292795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.