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 |
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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
|
|
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
|
|
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.â€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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