| CTRI Number |
CTRI/2024/08/072383 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between effectiveness of kinesio taping and rigid taping with common use of cryotherapy in athletes with medial tibial stress syndrome |
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Scientific Title of Study
|
Effectiveness of Kinesio taping versus rigid taping with common use of cryotherapy in athletes with Medial tibial stress syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rupam Nandi |
| Designation |
Master of physiotherapy student |
| Affiliation |
Burdwan Institute of Medical and Life Sciences |
| Address |
Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University CAampus ,Golapbag, University Road,Barddhaman, West Bengal 713104
Barddhaman
WEST BENGAL
713104
India |
| Phone |
9083324907 |
| Fax |
|
| Email |
rupamnandi2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amartya Mallick |
| Designation |
Assistant Professor |
| Affiliation |
Burdwan Institute of medical and life sciences |
| Address |
Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University CAampus ,Golapbag, University Road,Barddhaman, West Bengal 713104
Barddhaman
WEST BENGAL
713104
India |
| Phone |
9547207113 |
| Fax |
|
| Email |
dr.amartyamallick20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyen Bhattacharyya |
| Designation |
Associate Professor |
| Affiliation |
Burdwan Institute of Medical and Life Sciences |
| Address |
Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University CAampus ,Golapbag, University Road,Barddhaman, West Bengal 713104
Barddhaman
WEST BENGAL
713104
India |
| Phone |
8348050005 |
| Fax |
|
| Email |
fitofine.in@gmail.com |
|
|
Source of Monetary or Material Support
|
| Exercise therapy lab, Department of physiotherapy , Burdwan institute of medical and life sciences, University campus , Golapbag, University road, Barddhaman |
|
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Primary Sponsor
|
| Name |
Rupam Nandi |
| Address |
Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University CAampus ,Golapbag, University Road,Barddhaman, West Bengal 713104
|
| Type of Sponsor |
Other [OPD of Physiotherapy College] |
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rupam Nandi |
Burdwan institute of medical and life sciences |
Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road,Barddhaman
Barddhaman
WEST BENGAL |
9083324907
rupamnandi2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF BURDWAN INSTITUTE OF MEDICAL AND LIFE SCIENCES BARDHAMAN INDIA |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kinesio Taping (KT) |
kinesio taping (KT) has emerged as a popular treatment for medial tibial stress syndrome. Kinesio taping (KT) Has been used by elite athletes to provide mechanical support for the musculoskeletal system for injury prevention and post rehabilitation. KT is a thin tape that has elastic properties similar to the skin, which allows it to function in its natural range of motion. when applied with appropriate tension, KT lifts the fascia and soft tissue and produces additional space below the area of application which is said to enhance clearance of extra fluid of edema and bleeding by improving circulation and normalize muscle function by realigning fascial tissue and providing increased proprioceptive input. these effects are postulated to bring about immediate reduction of pain and improved athletic performance. KT decreased the rate of medial plantar loading among patients with a history of MTSS and suggested that application of K-tape may prove beneficial in relieving symptoms of medial tibial stress syndrome. |
| Comparator Agent |
Rigid Taping (RT) |
The primary objective of the tape is to restrict the movement of ligaments, tendons and joints to prevent injury or re-injury under high stress conditions. Stabilize or support associate injury relieve pain by de-loading vulnerable or painful structures Facilitate traditional movement,
muscle action, or bodily property patterns. Acceptable application of tape has been found to cut back the symptoms of medial leg bone stress syndrome or shin splint. Tape recording has vital blessings in aiding the patient in maintaining traditional biomechanics throughout participation. Rigid tape recording plays a big role in the reduction of pain kind to physical activity. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Athletes with medial tibial stress syndrome clinically diagnosed by orthopaedician.
2. Players participating in regular training program presenting with history of pain located on the posteromedial border of the tibia induced by exercise that lasted for hours or days after exercise.
3. Diffuse tenderness/discomfort on palpation of the lower 1/3rd of posteromedial border of the tibia.
4.Age limit: 18 to 30 years.
5.Sex: Male and Female.
6. No history of paresthesia in involved extremity |
|
| ExclusionCriteria |
| Details |
1. Painful passive movement of the ankle.
2. History of fractures or surgery of the lower limb.
3. History of skin allergies to adhesive tape.
4. Preexisting skin conditions such as eczema, dermatitis, and psoriasis.
5. Positive tuning fork test for stress fracture and positive sphygmomanometer test for chronic compartment syndrome. |
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Alternation |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale (NPRS) |
1st day of treatment and after 4 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
23/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
INTRODUCTION Medial tibial stress syndrome (MTSS) is a common complaint among athletes, particularly in distance runners. Medial tibial stress syndrome is a frequent overuse lower extremity injury in athletes. MTSS is exercise-induced pain over the anterior tibia and is an early stress injury in the continuum of tibial stress fracture. MTSS do not usually manifest themselves in the same location. Pain is more common in the distal third of the tibia on the medial side or in the proximal region, as well as the anterior, posterior, lateral or medial side of the leg. Generally, the risk factors causing this syndrome are divided into two group: intrinsic and extrinsic risk factors. Extrinsic risk factors are related to the duration and intensity of exercises, history of activity, inappropriate shoes, and hard and uneven surfaces. Intrinsic factors also include an increase in body mass, a decrease in the foot arch, a drop in navicular, an increase in foot pronation, an increase in range of motion of ankle planter flexion, an increase in external rotation of the hip joint during flexion in men, kinematic changes in the forefoot and hindfoot and high and prolonged soleus muscle activity during the acceleration phase of running and biomechanical alterations when running. CLINICAL PERSPECTIVE Medial tibial stress syndrome in athletes generally involves one or more of several pathological, anatomically specific processes. 1.Bone stress 2.Vascular insufficiency 3.Inflammation 4.Raised intracompartmental pressure 5.Nerve entrapment (e.g. superficial peroneal nerve) MEDIAL TIBIAL STRESS SYNDROME SYMPTOMS Soreness or pain in the medial side of the tibia, more commonly in the distal region. A common source of pain is the central section of the medial tibia. On the other hand, medial tibial stress syndrome can affect the entire length of the leg. It is usual to describe lateral side soreness as dull and unpleasant. On movement, pain increases, and at rest, pain is subsided; it most commonly occurs at the initiation of a workout and lessens as the workout continues. The pain is usually more substantial the following day, but it will go away gradually. Pain can be felt even while the patient rests in severe and persistent MTSS, shin bone may be tender to the touch. Radiation to the foot, as well as dysesthesia, has been observed. Mild oedema with subcutaneous thickening of the tibial line can also be seen in MTSS patients. Pain from medial tibial stress syndrome can: •Commonly be felt on the inner lower part of the leg or front of the shin bone. •Start off as come-and-go discomfort with activity and progress to a steady and persistent pain even after the activity has ended. •Dull ache type of pain. •Get worse after activity. RATIONALE OF THE STUDY Medial tibial stress syndrome (MTSS) is an injury caused by vigorous exercise along the posterior medial part of the tibia. It is one of the most common problems of athletes and is considered one of the most prevalent overuse-induced pain in this population. The condition characterized by pain along the postero-medial aspect of the distal two-thirds of the tibial that occurs before, during or after activity. The exact cause and pathophysiology behind medial tibial stress syndrome are still unclear. Repetitive stress that generates microdamage beyond the repair threshold could be a mechanism for developing medial tibial stress syndrome. The treatment of medial tibial stress syndrome focuses on providing symptomatic relief and modifying the risk factors. In recent years, two approaches to medial tibial stress syndrome have gained popularity: the Kinesio Taping and the Rigid Taping, both of which often use with cryotherapy. While both approaches have been shown to be effective in medial tibial stress syndrome rehabilitation, there is limited research comparing the two approaches with cryotherapy. Therefore, a study comparing the efficacy of the two approaches with cryotherapy would be valuable in determining the optimal rehabilitation protocol for medial tibial stress syndrome in athletes. The effect of Kinesio Taping and Rigid Taping has been documented in several literatures. The study which has been done earlier was only for short-term (for 3 days). There has been no significant improvement noted with Kinesio Taping and Rigid Taping. Therefore, in this study we want to compare the effectiveness of Kinesio Taping and Rigid Taping for reducing the pain. The rationale for conducting such a study is two-fold. First, understanding the relative efficacy of different rehabilitation approaches can help clinicians make informed decisions regarding the most appropriate treatment for individual patients. Secondly, as medial tibial stress syndrome rehabilitation can be a lengthy and costly process, identifying the most effective approach can help reduce the duration and cost of rehabilitation. Overall, a study comparing the Kinesio Taping and Rigid Taping approaches with cryotherapy in medial tibial stress syndrome rehabilitation would provide valuable insights into the most effective and efficient rehabilitation protocols for medial tibial stress syndrome in athletes. RESEARCH HYPOTHESIS NULL HYPOTHESIS (Ho): There will be no significant difference between the Effectiveness of Kinesio Taping vs Rigid Taping with common use of cryotherapy in athletes with medial tibial stress syndrome. ALTERNATIVE HYPOTHESIS (H1): There will be significant difference between the Effectiveness of Kinesio Taping vs Rigid Taping with common use of cryotherapy in athletes with medial tibial stress syndrome.
Athletes will be fully informed about the treatment procedure and written consents will be collected from the athletes. 30 athletes diagnosed by Medial tibial stress syndrome randomly selected by inclusion and exclusion criteria of the study. The athletes will be conveniently selected and randomly allocated into two groups equally, Group A and Group B. Each group will contain 15 athletes. Pre-treatment scores will be taken from subjects, which will include assessment of Numeric pain rating scale. After completion of a treatment period of 4 weeks, post treatment scores will be taken to find out the difference between the pre and post treatment scores. TREATMENT PROCEDURE Group A: Each patient of this group will be treated with Kinesio Taping along with Cryotherapy. This treatment protocol will be done 3 sessions in a week for up to 4 weeks. Cryotherapy will be applied over entire leg by ice cube massage technique for 10 minutes. Thereafter, Kinesio Tape will be applied to the lower leg. The tail of a single Y-strip of Kinesio Tape will be placed on the proximal third of medial tibia. Each half of the Y-strip will be applied in a manner that they lay anterior and posterior to the medial malleolus and terminated under the medial longitudinal arch of the foot. No tension will be applied on the proximal and distal ends of the tape; while the remainder of the tape will be applied with 75% tension. Group B: Each patient of this group will be treated with Rigid Taping along with Cryotherapy. This treatment protocol will be done 3 sessions in a week for up to 4 weeks. Cryotherapy will be applied over entire leg by ice cube massage technique for 10 minutes. A 6inch strip of white nonelastic adhesive tape will be torn and cut into a Y-shape. The tail of the tape will be placed on the base of the proximal third of the medial tibia, and the ends of the tape will be placed medial and lateral to the medial malleolus and terminated under the medial longitudinal arch of the foot. EXPECTED OUTCOME Both groups are expected to show improvement as 4 weeks of intervention should produce some results. However, they are statistically significant and if there will be any difference between the two interventions remains to be seen.
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