| CTRI Number |
CTRI/2019/03/018262 [Registered on: 26/03/2019] Trial Registered Prospectively |
| Last Modified On: |
09/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Manual Therapy for ankle sprain |
|
Scientific Title of Study
|
The effectiveness of Mobilization with Movement on pain, balance and function following acute and subacute inversion ankle sprain – A placebo 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 |
Neha Gogate |
| Designation |
Post graduate student |
| Affiliation |
Smt. Kashibai Navale College of physiotherapy |
| Address |
Smt. Kashibai Navale College of Physiotherapy Department of Musculoskeletal Physiotherapy Off Westerly By pass, Narhe Pune
Pune
MAHARASHTRA
411009
India |
| Phone |
7798989643 |
| Fax |
|
| Email |
nehagog25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kiran Satpute |
| Designation |
Assistant Professor |
| Affiliation |
Smt. Kashibai Navale College of physiotherapy |
| Address |
Smt. Kashibai Navale College of Physiotherapy
Department of Musculoskeletal Physiotherapy
Off Westerly By pass, Narhe Pune
Pune
MAHARASHTRA
411041
India |
| Phone |
9604515338 |
| Fax |
|
| Email |
kiran_ptist@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Kiran Satpute |
| Designation |
Assistant Professor |
| Affiliation |
Smt. Kashibai Navale College of physiotherapy |
| Address |
Smt. Kashibai Navale College of Physiotherapy
Department of Musculoskeletal Physiotherapy
Off Westerly By pass, Narhe Pune
Pune
MAHARASHTRA
411041
India |
| Phone |
9604515338 |
| Fax |
|
| Email |
kiran_ptist@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Smt. Kashibai Navale College of Physiotherapy
Department of Musculoskeletal Physiotherapy
Off Westerly By pass, Narhe Pune |
|
|
Primary Sponsor
|
| Name |
Smt Kashibai Navle College of Physiotherapy |
| Address |
Off Westerly Bypass Narhe Pune 411041 Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Neha Gogate |
Smt Kashibai Navale College of Physiotherapy |
Department of Musculoskeletal Physiotherapy
Off Westerly By pass, Narhe Pune
Pune
MAHARASHTRA |
7798989643
nehagog25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt. Kashibai Navale College of Physiotherapy, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobilisation with movement(MWM) and Conventional treatment |
1. MWM for inversion ankle sprain as described by Mulligan - Patient is lying supine with foot and ankle resting on the end of the plinth, a pain-free posterior glide of the distal fibula is carried out with respect to the stabilized tibia. While the fibula glide is sustained the patient performs pain-free ankle inversion to the maximum available range.
2. 6 to 8 repetitions per set, with 3 sets
3. Following the MWM 2 layers of rigid tape will be applied to the patient’s distal fibula spiraling proximally around the leg, replicating the MWM procedure
4. Conventional treatment-
Immobilization in posterior ankle brace for not more than 2 weeks
Non weight bearing or weight bearing ambulation as tolerated.
Ice application X 20 mins / 3 times a day
Compression- using a compression bandage
Elevation of the leg while lying or resting
Non weight bearing ankle dorsiflexion and plantarflexion mobility exercises for initial 1 week
Weight bearing ankle dorsiflexion range of motion progressed based on patient response.
Strengthening exercises to ankle musculature progressed based on patient response.
Proprioceptive and balance trainingprogressed based on patient response.
|
| Comparator Agent |
Placebo and Conventional treatment |
1. Sham MWM - Patient is lying supine with foot and ankle resting on the end of the plinth, Contact round the fibula and tibia in similar manner to that of MWM but no force is applied directly to the fibula while the patient does ankle inversion within limit of pain.
2. 6 to 8 repetitions per set, with 3 sets
3. Sham tape will be applied to the ankle 10 cms above to that of the MWM position without replicating the MWM procedure
4. Conventional treatment -
Immobilization in posterior ankle brace for not more than 2 weeks
Non weight bearing or weight bearing ambulation as tolerated.
Ice application X 20 mins / 3 times a day
Compression- using a compression bandage
Elevation of the leg while lying or resting
Non weight bearing ankle dorsiflexion and plantarflexion mobility exercises for initial 1 week
Weight bearing ankle dorsiflexion range of motion progressed based on patient response.
Strengthening exercises to ankle musculature progressed based on patient response.
Proprioceptive and balance trainingprogressed based on patient response.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Grade 1 and 2 inversion acute and subacute ankle sprain |
|
| ExclusionCriteria |
| Details |
1. Grade 3 ankle sprain
2. Associated fractures of the lower extremity
3. Any open wound around the ankle
4. Chronic ankle injury
5. If pain increases by 2 or more on the Numerical Rating Scale (NRS) during the MWM intervention
6. Contraindications to manual therapy
7. Contraindications to tape application
8. Withdrawal of informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Worst pain intensity in the previous 24 will be measured on Numeric Rating Scale (NRS) for Pain:
NRS is a single 11-point numeric scale with 0 representing “no pain†and 10 representing the “worst pain imaginable
|
2 weeks, 1 month and 6 months post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Ankle Disability by Foot Ankle Disability index (FADI)
2. Ankle Functional dorsiflexion range of motion
3. Peripheral sensitization by pain pressure threshold
4. Y balance test (YBT)
5. Central sensitization by pain pressure threshold over mid-deltoid |
2 weeks , 1 month and 6 months post intervention |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2019 |
| Date of Study Completion (India) |
09/06/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a parallel group single blind, placebo controlled randomised trial with the objective of comparing the effect of Mobilization with movement and conventional therapy with placebo and conventional treatment. Total 32 subjects with grade 1 or grade 2, acute or sub-acute ankle inversion sprain will be recruited and will be allocated to either group with simple computer generated allocation. Worst pain intensity in the previous 24 will be measured on Numeric Rating Scale (NRS) for Pain as primary outcome. Secondary outcomes include Foot Ankle Disability index (FADI), Ankle Functional dorsi-flexion range of motion, Peripheral sensitization by pain pressure threshold, Y balance test (YBT), Central sensitization by pain pressure threshold over mid-deltoid. Outcome measures will be assessed at baseline prior to treatment, at the end of 2 week, 1 month and 6 months post intervention. Subjects will receive treatment for 2 weeks, 3 sessions per week, for a total of 6 sessions. Home exercise program will be given at the end of trial which will be progressed as per patient’ s response. After completing data collection, analysis will be done on intention to treat basis. |