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CTRI Number  CTRI/2022/04/041799 [Registered on: 11/04/2022] Trial Registered Prospectively
Last Modified On: 01/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment For Unstable Ankles. 
Scientific Title of Study   The Effectiveness Of Strain Counter-Strain With Passive MWM In The Treatment Of Patients With Chronic Ankle Instability: A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pooja Yadav 
Designation  MPT STUDENT 
Affiliation  DR. A.P.J. ABDUL KALAM COLLEGE OF PHYSIOTHERAPY 
Address  DR. A.P.J.ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, PRAVARA INSTITUTE OF MEDICAL SCIENCES, LONI, AHMADNAGAR
DR. A.P.J.ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, PRAVARA INSTITUTE OF MEDICAL SCIENCES, LONI, AHMADNAGAR
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8652552561  
Fax    
Email  dr.pooja.yadav333@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejas Suryavanshi 
Designation  Professor 
Affiliation  DR. A.P.J. ABDUL KALAM COLLEGE OF PHYSIOTHERAPY 
Address  DR. A.P.J.ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, PRAVARA INSTITUTE OF MEDICAL SCIENCES, LONI, AHMADNAGAR
DR. A.P.J.ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, PRAVARA INSTITUTE OF MEDICAL SCIENCES, LONI, AHMADNAGAR
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9552310517  
Fax    
Email  tejaskshitija@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tejas Suryavanshi 
Designation  Professor 
Affiliation  DR. A.P.J. ABDUL KALAM COLLEGE OF PHYSIOTHERAPY 
Address  DR. A.P.J.ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, PRAVARA INSTITUTE OF MEDICAL SCIENCES, LONI, AHMADNAGAR
DR. A.P.J.ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, PRAVARA INSTITUTE OF MEDICAL SCIENCES, LONI, AHMADNAGAR
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9552310517  
Fax    
Email  tejaskshitija@gmail.com  
 
Source of Monetary or Material Support  
Dr.A.P.J.Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences 
 
Primary Sponsor  
Name  NONE 
Address  NONE 
Type of Sponsor  Other [NONE] 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Pooja Yadav  Dr. A.P.J. Abdul Kalam College of Physiotherapy  orthopaedic physiotherapy department, 4th floor, 403
Ahmadnagar
MAHARASHTRA 
8652552561

dr.pooja.yadav333@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Ankle Instability 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  None  None 
Intervention  Strain Counter Strain With Movement With Mobilization  1.Ethical clearance will be obtained from the IEC 2.Patient will be evaluated based on the inclusion exclusion criteria and based on the assessment form including demographic data, age, gender, history of ankle sprain, involved side, frequency of giving away and activity level. 3.Participants will go a physical examination where their ROM of ankle will be assessed by universal goniometer. 4.Participants will be assessed for MMT, ankle stability test (ant drawer test, talar tilt test and medial subtalar glide test) for assessment of mechanical instability and SCS tender points will also be evaluated. 5.Participants meeting the inclusion criteria will be randomized into 3 groups. 6.Group A will be receiving pre-set protocol of SCS with passive MWM (3 times /week) for 4 weeks. 7.Group B will receive pre-set protocol of SCS. (3 times /week) for 4 weeks. 8.Group C will be the control group hence conventional treatment will be given. 9.All the instructions will be given verbally, provided demonstration and guided. 10.Patients will be assessed twice during the treatment, once before the commencement of treatment and once after the treatment is done. i.e post 4 weeks. 11.Data will be collected and comparison will be done based on the result obtained in the outcome measures.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.History of minimum one episode of ankle sprain 3 months earlier.
2.Feeling of giving way in ankle.
3.Subjects of either gender in an age group of 18-55 years.

 
 
ExclusionCriteria 
Details  1.History of ankle fracture/surgery.
2.Recent soft tissue injury at ankle.
3.Neurologic deficit.
4.Pregnant woman.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Balance Master  baseline, 2 weeks post treatment, 4 weeks post treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Chronic Ankle Instability Tool  baseline, post 2 weeks, post 4 weeks 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/04/2022 
Date of Study Completion (India) 31/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/01/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Ankle sprain is considered as the most common injury occurring in the active population.1 All patients with the history of previous ankle sprain developed symptoms such as decreased range of motion of dorsiflexion, laxity of ligaments, loss of proprioception, pain during activity, swelling and also the feeling of “giving way” and ankle instability.1 chronic ankle instability is defined by Hertel et al. as “repetitive bouts of lateral ankle instability resulting in numerous ankle sprains.”1 Chronic ankle instability is also considered as a complex ankle disorder that was caused by mechanical instability, functional instability, or could be the combination of both the conditions.1 Mechanical instability is objective and involves ankle joint movement beyond physiological range of motion, Whereas Functional instability is considered as the feeling of instability which is subjective in nature and is in relation with a proprioceptive neuromuscular dysfunction.1 intrinsic and extrinsic are the predisposing factors that could lead to chronic ankle instability.1 extrinsic factors are type of ground surface, types of footwear, physical activity. Intrinsic factors include ratio of increased ankle eversion to inversion strength, dorsiflexion to plantarflexion strength ratio, plantarflexion strength, dominance of limb, decreased ROM, postural control or lower leg alignment. Manual therapy approach tends to lengthen the joint capsule and ligaments associated with it by stretching them through accessory motion in order to restore dorsiflexion range of motion by increasing the extensibility of non-contractile tissues.  Mobilization with movement is considered effective in improving function, persistent instability feeling, ankle range of motion of dorsiflexion, reducing swelling and pain, improving function and postural control in patients suffered with lateral ankle sprains. Some of these symptoms are present together or individually in which conventional treatment has been inefficient. In chronic ankle instability it appears that functional and mechanical impairments co-exist. Muscle inhibition has been identified in the fibularis longus and soleus muscles in cases of functional instability of ankle.2 Needle et al suggested that subjective instability might be related to deficits in muscle spindle function during mechanical loading of the ankle.2 Pietrosimone et al concluded that alterations were seen in neuromuscular function post joint injury contributed to altered biomechanics affecting long term functional outcomes.2 Hence these studies are in support that there is presence of neuromuscular dysfunction in CAI.2

Strain counterstrain is an indirect osteopathic treatment which describes the theatrical mode of neuro-muscular skeletal dysfunction where a mechanical strain injury leads to changes in muscle spindle around the involved segment known as the proprioceptive theory. Based on this theory, during lateral ankle sprain the affected foot turns into inversion hence the spindles of invertor muscles adapt to a newly shortened muscle length.2 The quick stretch and resulting contraction of the evertor muscles causes the invertor muscles to be quickly stretched from the adapted shortened position, leaving the invertor muscles in a state of increased neuromuscular hyperactivity with a facilitated spindle system. According to the proprioceptive theory, this scenario leaves the ankle in a state of neuro muscular skeletal dysfunction which in future leads to chronic ankle instability and hence repeated episodes of ankle sprains.

In strain counterstrain dysfunctional muscle groups are identified through localization of significant tender points which are defined as small zones of tense, tender, and edematous muscle  and fascial tissue about 1 cm in diameter and is 4 times more tender as compared to the normal tissue.2  authors like Stillwell and melzack [48] concluded that there may not be any significant difference  between SCS point and trigger point, a reduction in the tenderness degree of SCS tender point  is associate with a modification of body position. However, till date no assessment too is available which can assess SCS tender points.

The role of soleus and gastrocnemius muscle tightness has also been considered as the contributing factor for restriction of the range of motion of dorsiflexion nevertheless following the results obtained by Johanson in 2008, range of motion of  dorsiflexion seems to be more in relation with subtalar joint than muscle tightness.1 there are some manual therapy techniques which are based on talocrural joint mobilization which have proven the effectiveness of this kind of stimuli in postural control, ROM of dorsiflexion and improvement in arthrokinematic. [2,9,20,21] during dynamic balance tasks balance is usually altered in patients with chronic ankle instability, this seems to be because of deficit in neuromuscular control and proprioception of the ankle joint.

 

NEED FOR THE STUDY

Conventional physical therapy techniques such as electrotherapy, taping, etc has been shown good results in decreasing the edema and pain which is associated with ankle sprain.1 nevertheless the improvement obtained with such therapies does not provide a remedy to the possible sequelae associated with sprain of ankles, such as muscle weakness, postural control deficits, nerve deficits, invertor  and evertor strength deficits, sensorimotor deficits, delayed peroneal muscle reaction time ,damage to ligamentous and capsular mechanoreceptors with dysfunction in the afferent–efferent mechanism, alterations in the dorsiflexion ROM of ankle joint, proprioception deficits, etc.1,2 for these reasons it is important to make integral approaches in the treatment of ankle sprain in order to avoid its reoccurrence. It is estimated that about 70% re-sprain occurs after the previous episode of ankle sprain. After the onset of ankle sprain range of motion of dorsiflexion at the ankle joint is affected, this is considered as a predisposing factor of re-injury. Range of motion of Dorsiflexion at the ankle joint is associated with positional alteration of the talus in relation with the ankle mortise or an alteration in normal talar arthrokinematics, being a reduced posterior talar glide.1 Another factor for recurrent ankle sprain is the decreased balance. Mobilization of joint is effective in reducing predisposing factors to re-injury and whose improvement is hypothesized to be derived by the posterior talar glide alteration. Literature suggests that the stretching of articular which is occurring due to mobilization of joints tends to increase the sensory output of mechanoreceptors in ligaments and capsules due to the activation of gamma motor neurons by tissue traction which is related to improvement of postural control. MWM can be used in acute and sub-acute ankle sprains in weight bearing or non-weight bearing conditions with the particularity of patient moves actively.1

Lack of required strength, functional weakness, foot laxity, neuromuscular imbalance etc. are proven intrinsic risk factors for increase in chances chronic ankle instability, hence it is imperative to study the effects of passive MWM with strain counterstrain to achieve functional as well as mechanical stability in the ankle and thus treating the root cause of chronic ankle instability.

 

 

Research question

 What will be the effect of Strain Counter Strain With Passive MWM In Patients With Chronic Ankle Instability, in terms of postural control, ankle stability and dynamic balance?

Hypotheses

Null hypotheses (H0)

There will be no effect in Strain Counter Strain With Passive MWM In Patients With Chronic Ankle Instability in terms of postural control and dynamic balance.

Alternate hypotheses (H1)

There will be significant effect in Strain Counter Strain With Passive MWM In Patients With Chronic Ankle Instability, in terms of postural control and dynamic balance.


 
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