| CTRI Number |
CTRI/2020/01/022923 [Registered on: 23/01/2020] Trial Registered Prospectively |
| Last Modified On: |
22/01/2020 |
| 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 Mckenzie exercises and motor control exercises on pain, disability and global improvement in patients suffering from low back pain over 3 months. |
|
Scientific Title of Study
|
Comparison between Mckenzie method versus motor control exercises on pain, disability and global improvement in patients with chronic low back pain. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raveena Vinod Gade |
| Designation |
Postgraduate student |
| Affiliation |
MGM Institute of Physiotherapy, Aurangabad. |
| Address |
MGM Institute of Physiotherapy,N-6, Cidco, Aurangabad.
OPD no 1, Musculoskeletal department, MGM Institute of Physiotherapy, N-6 Cidco Aurangabad-431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9561013107 |
| Fax |
|
| Email |
drraveenagade25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sibi Daniel Joseph |
| Designation |
Associate professor |
| Affiliation |
MGM Institute of Physiotherapy,N-6, Cidco, Aurangabad. |
| Address |
MGM Institute of Physiotherapy,N-6, Cidco, Aurangabad.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9096834592 |
| Fax |
|
| Email |
sibdanjo2k@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Raveena Vinod Gade |
| Designation |
Postgraduate student |
| Affiliation |
MGM Institute of Physiotherapy,N-6, Cidco, Aurangabad. |
| Address |
MGM Institute of Physiotherapy,N-6, Cidco, Aurangabad.
OPD no 1, Musculoskeletal department, MGM Institute of Physiotherapy, N-6 Cidco Aurangabad-431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9561013107 |
| Fax |
|
| Email |
drraveenagade25@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy, N 6, Cidco, Aurangabad 431003 |
|
|
Primary Sponsor
|
| Name |
MGM Institute of PhysiotherapyAurangabad |
| Address |
MGM Institute of Physiotherapy,N-6 Cidco, Aurangabad-431003 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Raveena Vinod Gade |
MGM Institute of Physiotherapy, Aurangabad |
OPD no 1, Musculoskeletal department, MGM Institute of Physiotherapy, N-6 Cidco Aurangabad-431003
Aurangabad
MAHARASHTRA |
9561013107
drraveenagade25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM-ECRHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mckenzie and Motor control exercise |
Treatment involved mechanical therapy including patient and therapist generated forces utilizing repeated or sustained end range loading strategies in loaded or unloaded postures according to the patients’ directional preference. The force and loading strategy was guided by symptom response.
Patients will be instruct to practice exercises daily at home for 30-minutes. Patients will be encourage to attend twice a week for the first four weeks and once per week for the remaining four weeks Patients will be instruct to practice exercises daily at home for 30-minutes.
Independent contraction of the deep stabilizing muscles such as Transversus abdominis and multifidus will be facilitated by pelvic floor contraction leading to their co-contraction, Instructions for the patient:
1. Drawing in maneuver
2. Slowly and gently swell the muscle into examiner’s fingers. (Lateral to spinous process in the lumbar spine).
3. Tense the PFM as if stopping the flow of urine.3
And instructions to control breathing by maintaining resting tidal volumes throughout deep trunk activation maneuvers.
•Progression will be achieved when mastery of contraction in static tasks will be achieved progressing to implementation of deep muscle contraction during dynamic tasks.
•Therapists provided feedback on the performance of exercises while less prompting will be provided as the patient mastered the skill.
•Objectively skill mastery of Transversus abdominis recruitment will be measured by palpation and visual assessment for a reduction of over activity of the superficial trunk muscles during static and dynamic tasks.
Patients will be instruct to practice exercises daily at home for 30-minutes.
Patients will be encourage to attend twice a week for the first four weeks and once per week for the remaining four weeks Patients will be instruct to practice exercises daily at home for 30-minutes. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Greater than 3 – month history of Low back pain.
2.A directional preference observed with a mechanical assessment based on the McKenzie method.
3.The area of pain localized between the twelfth rib and the buttock crease.
4.Patients reporting referred pain with or without sensory and motor changes.
5.Patients reporting referred pain in one or both the legs.
|
|
| ExclusionCriteria |
| Details |
1 Lacked adequate comprehension of language skills to comply with treatment or read study material.
2 Metastatic disease.
3 History of spinal fracture and previous surgery.
4 Pregnancy.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Visual Analogue scale
2 Modified Oswestry low back pain disability questionnaire
3 Global perceived effect questionnaire
|
Baseline on the 1st day
postintervention at the end of 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Visual Analogue scale at the end of 8 week.
2 Modified Oswestry low back pain disability questionnaire at the end of 8 week.
3 Global perceived effect questionnaire at the end of 8 week.
|
10-15 minutes |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/01/2020 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This randomized clinical trial is to compare the effects
between the McKenzie method and Motor control exercises on pain, disability and
global improvement in 76 patients with chronic low back pain. Exercise therapy
has been shown to have beneficial effects for the management of chronic LBP.
Two popular forms of exercise used to manage LBP are Mechanical Diagnosis and
Therapy referred to as the McKenzie method and motor control exercises. The
study had done to compare the McKenzie method to motor control exercises in
people with chronic low back pain. However the primary outcome used in the
study was the recruitment of the trunk muscles Transversus abdominis, obliqus
externus and obliqus internus using ultrasound images. Change in muscle
thickness measure is not clinically important to patients. Patient reported
outcomes of pain and disability are clearly more important than muscle
thickness changes for investigating the clinical importance of different
interventions. There will be two groups McKenzie method group and Motor control
exercises group. Patients will receive 12 treatment sessions over an 8-weeks
period. The outcome measures are Visual Analogue scale, Modified Oswestry low
back pain disability questionnaire, Global perceived effect questionnaire at
baseline and at 8th week. |