| CTRI Number |
CTRI/2024/01/061863 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Core Stabilization exercises and Lumbar mobilization in Degenerative lower back pain |
|
Scientific Title of Study
|
Effect of Core Stabilization exercises and Lumbar mobilization on pain,IL-6 and muscle activity
in Lumbar Spondylosis.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lilima Patel |
| Designation |
Assistant Professor |
| Affiliation |
PhD Scholar |
| Address |
Department of Physiotherapy,
Apollo Institute od Mediocal Sciences and Research,Jubilee Hills
JN Clinic , Madhapur
Hyderabad
TELANGANA
500096
India |
| Phone |
9330664224 |
| Fax |
|
| Email |
lilimapatel853@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lilima Patel |
| Designation |
Assistant Professor |
| Affiliation |
Assistant Professor and Ph.D Scholar |
| Address |
Department of Physiotherapy,Apollo Institute of Medical Sciences and Research,Hyderabad
JN Clinic,Hyderabad
Hyderabad
TELANGANA
500096
India |
| Phone |
9330664224 |
| Fax |
|
| Email |
lilimapatel853@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lilima Patel |
| Designation |
Assistant Professor |
| Affiliation |
Assistant Professor and Ph.D Scholar |
| Address |
Department of Physiotherapy,Apollo Institute of Medical Sciences and Research,Hyderabad
JN Clinic,Hyderabad
Hyderabad
TELANGANA
500096
India |
| Phone |
9330664224 |
| Fax |
|
| Email |
lilimapatel853@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Institute and JN Clinic |
|
|
Primary Sponsor
|
| Name |
Lilima Patel |
| Address |
Department of Physiotherapy
Apollo Institute of Medical Sciences And Research |
| Type of Sponsor |
Other [] |
|
|
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 |
| LILIMA PATEL |
Apollo Hospital & JN Clinic |
Department of Physiotherapy,Apollo Institute of Medical Sciences and Research,Hyderabad
JN Clinic,Hyderabad
Hyderabad
TELANGANA |
09330664224
lilimapatel853@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Apollo Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M479||Spondylosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group will receive standardized exercises program.
|
Control group will receive standardized exercises program for three days per week for four weeks. |
| Intervention |
Core Stabilization and Lumbar Mobilization Group |
Intervention group will receive Maitland Lumbar mobilization and Core stabilization exercises along with standardized exercise program for three days per week for four weeks.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Lumbar spondylosis without radiculopathy.
(Kellegren Lawrence grading 2 to 3)
2.Age groups—40 to 60 years.
3.Gender—male and female.
4.History of slow, insidious onset of pain.
5.On Physical examination
Limited ROMs of lumbar spine like extension, flexion or side flexion.
Nature of pain -aching pain.
6.Diagnosis confirmed by X-Ray showing signs of degeneration.
|
|
| ExclusionCriteria |
| Details |
1.Subject with history of Previous spinal surgery & fractures.
2.Presence of Spinal deformity-scoliosis, Spinal neoplasm or metastatic disease
3.Progressive neuropathy or progressive lumbosacral radiculopathy, neurological deficits.
4.Spondylolysis, Spondylolisthesis & Osteoporosis.
5.Known rheumatic, neurologic, or mental diseases.
6.Other red flags (contra-indications) to manual therapy and LASER.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale
IL6 Blood Test
Surface EMG |
Baseline and at the end of 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Bubble Inclinometer.
Oswestry Disability Index.
|
Baseline and at the end of 4th week |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 16-12-2023 and end date provided 16-12-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NOT APPLICABLE
|
|
Brief Summary
|
Effect of Core Stabilization Exercises and Lumbar Mobilization on Pain, IL-6 and Muscle activity in Lumbar Spondylosis Lumbar Spondylosis (LS) is a
degenerative condition of lumbar spine affecting intervertebral disc and
vertebral bodies.With advancing age,
degenerated disc released proinflammatory mediators like IL6 which initiate the
inflammation resulting into pain and alter muscles activity as well as recruitment
pattern of deep core muscles like Transverse Abdominis and Lumbar
multifidus, which might affect stability of
spine.Apart from this, Interleukin-6 also
induces bone resorption and degeneration which reduces lumbar mobility.
Hence, the purpose of this trial
is to find out the added effect of
core stabilization exercise and lumbar mobilization in Lumbar spondylosis on
pain intensity, IL6, muscle activity, lumbar ROM and function. |