| CTRI Number |
CTRI/2018/04/013028 [Registered on: 04/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/03/2018 |
| 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
|
Comparing Two Methods of Treatments for improving hand function after Wrist Fractures |
|
Scientific Title of Study
|
Comparison of Mobilization with Movement and Muscle Energy Technique for patients with Distal End Radius Fracture |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita Mehta |
| Designation |
PG Student |
| Affiliation |
|
| Address |
Room No- 2, 1st Floor,
Sancheti Institute College of Physiotherapy, Thube Park, Shivajinagar, Pune-411005
Pune
MAHARASHTRA
411005
India |
| Phone |
8007971597 |
| Fax |
|
| Email |
ankitamehta1592@gmial.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nilima Bedekar |
| Designation |
Professor |
| Affiliation |
|
| Address |
Room No- 2, 1st Floor,
Sancheti Institute College of Physiotherapy, Thube Park, Shivajinagar, Pune-411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9420861882 |
| Fax |
|
| Email |
nilimabedekar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nilima Bedekar |
| Designation |
Professor |
| Affiliation |
|
| Address |
Room No- 2, 1st Floor,
Sancheti Institute College of Physiotherapy, Thube Park, Shivajinagar, Pune-411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9420861882 |
| Fax |
|
| Email |
nilimabedekar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room No- 2, 1st Floor,
Sancheti Institute College of Physiotherapy, Thube Park, Shivajinagar, Pune-411005 |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute Of Orthopaedics and Rehabilitation |
| Address |
Cubicle No-4,Basement,
Sancheti Institute of Orthopaedics and Rehabilitation, Shivajinagar, Pune-411005 |
| 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 |
| JAMES GHAGHARE |
Sancheti Institute of Orthopaedics and Rehabilitation |
Room No- 4 ,Basement
Sancheti Hospital
Shivajinagar
Pune
411005
Pune
MAHARASHTRA |
9923006964
jamesphysio_2002@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board Sancheti Insitute for Orhtopaedics and Rehabilition, Pune |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Distal End Radius Fracture (Post 6 weeks after injury), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Exercises Group |
(INSTITUTIONAL PROTOCOL)
Patient position-Sitting/ standing-All exercises for 10 times each thrice in the day.
1.Shoulder shrugs
2.Scapular retraction
3.ISOMETRIC EXERCISE-Wrist flexors and extensors
4.ACTIVE ROM EXERCISE
•Assisted stretch to forearm flexors and extensors and radial/ulnar deviation
•Weight bearing wrist extension exercise(hands on the table with the patient leaning forward on them) to patient tolerance
•Repetitive squeezing of smiley ball
•Active stretch to shoulder girdle and rotator cuff musculature ,elbow flexor and extensor musculature
•Active ROM exercises of Shoulder and Elbow
•Composite fist with help of unaffected hand
•Various types of grasping exercises like- hook grasp, pinch grasp, Lateral prehension
5.INTRINSIC HAND MUSCLE EXERCISE
•Thumb/digit opposition
•Repetitive squeezing of theraputy
•Repetitive towel wringing exercise
6.TENDON GLIDING EXERCISES
A] Immobilized wrist
•Straight position(MP, PIP, and DIP joints extended)
•Platform position(MP joints flexed, PIP and DIP joints extended)
•Straight fist(MP and PIP joints flexed, DIP joints extended)
•Hook fist(MP joints extended, PIP and DIP joints flexed)
•Full fist (MP, PIP, and DIP joints flexed)
B] Mobile wrist
•Synergistic wrist flexion and finger extension and vice versa
•Active and passive finger extension with wrist extended
•Active and passive thumb extension with wrist neutral in ulnar deviation
7.PATIENT EDUCATION-Patient were encouraged to resume pre-accident activities that involve the affected extremity (eg. Writing, typing, cooking, etc)
Elevation to be maintained at home periodically to reduce swelling
To apply ice for 5-7 mins post exercise for 3-4 times/ day for 1 week
Contrast Bath was adviced in the 2nd week.Patients were asked to immerse their hand in cold water followed by luke warm water in 1:2 ratio as regards the time.They had been asked to repeat the same for 3 times/day for 2 weeks.
|
| Intervention |
Mulligan Mobilization Group |
Patients in this group received Mulligan’s Mobilization With Movement along with other exercise programme as given to Group A.
MWM was given for Wrist Flexion/Extension,Radial/Ulnar Deviation and Pronation/Supination at both Superio and Inferior Radio-ulnar Joint
A rule of three was followed i.e.3 repetitions of MWM were given on the first day followed by 3 sets of 10 repetitions each.
The glide was maintained for 5-10 seconds. The period of time between each repetition was no longer than 60 s. |
| Intervention |
Muscle Energy Technique |
Patients in this group received Muscle Energy Technique in the form of Reciprocal Inhibition and Post Isometric Relaxation along with other exercise programme as given to Group A .
The procedure was repeated 3-5 times as per patient’s tolerance with one session per day.8-10 repititions.
Post Isometric Relaxation (PIR):
For Example for Wrist Extension :
Patient was in supine position with elbow rested on plinth.
The targeted muscle group was taken at a point where the first resistance was perceived.
The patient was asked to use no more than 20% of available strength to attempt to take the wrist in extension.
The therapist applied the resistance equally without allowing any movement by the patient, seeing to it that the contraction was slow, without any jerking, wobbling or bouncing.
The contraction was held for about 7-10 seconds and was repeated 7-10 times with an interval of 10-20 seconds which is a latent period during which the extensor muscles were taken to its new resting length. RI for Wrist Flexion
Reciprocal Inhibition (RI):
Patient was taken to the range at which first resistance is obtained. The resistance was given by the therapist against the action of flexors, not allowing patient to overcome the resistance and was held for 20 seconds.The patient was asked to relax after 20 seconds and the extensors were taken to its new length. The patient was then asked to do active wrist extension to help the effective contraction of extensors.
The same procedure was followed for all the movements at the Wrist i.e. Flexion, Radial Deviation and Ulnar Deviation and at the Radio-Ulnar Joint i.e. Pronation and Supination. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Pain –VAS score >5/10
2.Only Unilateral cases
3.Patient diagnosed with Distal End Radius Fracture (Post 6weeks from day of injury)
Mode of Treatment selected were – Conervatively managed with Plaster of Paris cast, Closed reduction with K-wire, open reduction internal fixation with Ellis plating, External Fixator.
|
|
| ExclusionCriteria |
| Details |
Patients having any recent injuries to the Hand ,Wrist, Elbow and Shoulders in the past 1 year on the ipsilateral side.
Patients who have had Distal End Radius Fracture in the past. (Re-fracture cases due to osteoporosis or any other reasons)
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain evaluation- Visual Analogue Scale
ROM- Wrist and Radioulnar Joint Range of Motion with half cicrle goniometer
Function-Disability of Arm, Shoulder and Hand (DASH)
Grip Strength- Grip Dynamometer
|
1.On the day of 1st session(Pre-treatment)
2.At end of 2 weeks post treatment
3.At end of 4 weeks post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain evaluation- Visual Analogue Scale
ROM- Wrist and Radioulnar Joint Range of Motion with half cicrle goniometer
Function-Disability of Arm, Shoulder and Hand (DASH)
Grip Strength- Grip Dynamometer
|
Patients were assessed on the first day before treatment ,at end of 2nd weeks and at the end of 4th weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/05/2016 |
| Date of Study Completion (India) |
10/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
BACKGROUND: Fracture of the distal radius is a common clinical problem particularly in elderly women with osteoporosis. The effects of various
physiotherapeutic techniques have been studied with less literature proving the
efficacy of one over the other.
OBJECTIVE:. To compare the effects of Mobilization
With Movement (MWM) and Muscle Energy Technique (MET) in patients with distal
end radius fracture for reducing pain, improving Range of Motion ,Grip Strength
and Functional Status.
DESIGN: Double blinded, randomized
controlled trial.
METHOD: 60 patients , 40-60 yrs , with
unilateral Distal End Radius Fracture included in the study and randomized with
computer generated allocation, being 20 in each group. Group A received
Conventional Exercises, Group B Mulligan Mobilization with movement and Conventional
Exercises and Group C Muscle Energy Technique and Conventional Exercises. The
VAS score, DASH score, Grip Strength and Radio-Carpal and Radio-Ulnar ROM were
evaluated before the intervention was started, at end of 2 week (supervised
intervention- minimum of 12 sessions out of 15) and at end of 4 week (home
exercise program- 15days). All groups were advised contrast bath at home and
home exercise program which included strengthening exercises. A mixed ANOVA was
done to analyze the data obtained.
RESULTS: All 3 groups showed a
significant improvement in all the parameter over time (p<0.05) Although, in
comparison among groups, MET with Conventional Exercises showed better results
as compared to MWM with Conventional Exercises.
LIMITATIONS: The study included patients
having any type of fracture of Distal End of Radius and mode of Treatment was
also not considered.
CONCLUSION: MET, MWM and Conventional Therapy
all are effective in reducing pain, improving ROM, Grip Strength and Functional
Status(DASH Score). MET with
Conventional Exercises ,being more effective as compared to other two treatment
techniques on basis of the same outcome measure at the end of 4 weeks.
|