CTRI Number |
CTRI/2023/11/060139 [Registered on: 22/11/2023] Trial Registered Prospectively |
Last Modified On: |
20/11/2023 |
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
|
Exercises to improve low back pain |
Scientific Title of Study
|
Effectiveness of kinetic control versus mckenzie exercises on functional outcomes in patients with lumbar radiculopathy - A Single Blinded Randomized Control Trial |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR KANCHAN DINKARRAO JOSHI |
Designation |
MPT First year Musculoskeletalsciences |
Affiliation |
D V V P Fs College of Physiotherapy |
Address |
Department of musculoskeltal physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar Ahmadnagar
MAHARASHTRA 414111 India
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar MAHARASHTRA 414111 India |
Phone |
7020410341 |
Fax |
|
Email |
joshikanchan1812@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR KANCHAN DINKARRAO JOSHI |
Designation |
MPT First year Musculoskeletalsciences |
Affiliation |
D V V P Fs College of Physiotherapy |
Address |
Department of musculoskeltal physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar Ahmadnagar
MAHARASHTRA 414111 India
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar MAHARASHTRA 414111 India |
Phone |
7020410341 |
Fax |
|
Email |
joshikanchan1812@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Deepak Anap |
Designation |
HOD Musculoskeletal sciences |
Affiliation |
D V V P Fs College of Physiotherapy |
Address |
Department of musculoskeltal physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar Ahmadnagar
MAHARASHTRA 414111 India
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar MAHARASHTRA 414111 India |
Phone |
9890200972 |
Fax |
|
Email |
deepak.anap@hotmail.com |
|
Source of Monetary or Material Support
|
DVVPFs College of Physiotherapy opp Govt milk dairy MIDC Ahmednagar |
|
Primary Sponsor
|
Name |
DVVPFs College of Physiotherapy |
Address |
Department of musculoskeletal sciences Block 1 basement DVVPFs
college of physiotherapy Oppo Govt Milk Dairy MIDC 414111
Ahmadnagar MAHARASHTRA |
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 |
DR DEEPAK ANAP |
D V V P Fs College of Physiotherapy |
Department of Musculo
skeletalsciences Opp
Govt Milk Dairy M I D C
Ahmednagar 414111
Ahmadnagar
MAHARASHTRA
Ahmadnagar
Ahmadnagar
MAHARASHTRA Ahmadnagar MAHARASHTRA |
9890200972
deepak.anap@hotmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
DVVPFS College of Physiotherapy Institutional ethical Committe Ahmednagar |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M488||Other specified spondylopathies, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Mckenzie Exercises |
Mckenzie Exercises: In this intervention patient have to perform directional based exercises on the basis of centralization or peripheralization of neurological symptoms .It includes Extension biased or Flexion Biased exercises for lumbar spine. Each exercise will be performed for 10 repetitions. |
Intervention |
Motor control exercises.
|
Kinetic control exercises: Each patient in group (A) will receive kinetic control retraining 3 sessions per week, for 4 weeks. For each movement direction, specific control tests will be conducted. The direction and site of the uncontrolled movement will be evaluated using special tests in accordance with the pain history of the patient. The tests will be chosen according to the patient’s symptoms; screening of all patients will done through at least three tests in each direction according to the patient’s symptoms. The aim of each test and the way of its performance will be explain to each patient.The tests of each direction of movement control included flexion movement control tests, extension movement control tests and rotation/side bending control tests.Kinesthetic training for awareness of safe motion & positions must procedes stabilization training. Activation of deep segmental muscles of trunk with extremity motions are added to the stabilization program to coordinate segmental muscle activity with global stabilizing musculature. Hence Lumbar Stabilization exercises will be performed by the patients.
|
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
•Subjects from both Genders diagnosed low back pain with radiculopathy and flexion and extension uncontrolled movement.
•Patients with lumbar radiculopathy due to lumbar disc prolapse(posterolateral or lateral disc prolapse (L4-L5/ L5-S1 levels) with clinical confirmation through the applied examination with MRI.
•Patients who are on the medications for the lumbar radiculopathy.
•The radiculopathy signs will be identified by the presence of LBP with numbness radiating below the knee, and the duration of illness will be from 3-6 months.
•Muscle strength deficit in any of the L4-S1myotomes;
|
|
ExclusionCriteria |
Details |
•Females with Gynecological problems that may cause low back pain.
•Patients with a previous spinal surgery, other radicular symptoms causes (e.g.: piriformis syndrome, diabetic neuropathy).
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Pain, Disability, Range Of Motion, Strength |
Baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
Pain,Disability, Range Of Motion, Strength |
4 week |
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
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)
|
30/11/2023 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [joshikanchan1812@gmail.com].
- For how long will this data be available start date provided 18-12-2024 and end date provided 31-12-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
The study is to see the effectiveness of kinetic control versus Mckenzie exercises on functional outcomes in patients with lumbar radiculopathy: A Single Blinded Randomized Control Trial. 52 subjects 26 in each group will be recruited based on inclusion and exclusion criteria. There will be 2 groups, Motor control exercises and Mckenzie exercise program will be given to each group for 4 weeks. Total treatment protocol will be of 4 weeks. Intervention should be given thrice a week upto 4 weeks. Data will be analyzed statistically |