| CTRI Number |
CTRI/2024/09/073483 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Finding Relief McGill Exercises vs Feldenkrais Method for Better Back Strength functionality and Less Pain |
|
Scientific Title of Study
|
Comparative effect of McGill stabilization
exercise vs Feldenkrais method on pain
functional disability and core strength in
patients with lumbar spondylosis
An Experimental study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Disha Lapani |
| Designation |
post graduate student |
| Affiliation |
SPB physiotherapy college |
| Address |
musculoskeletal physiotherapy department, SPB Physiotherapy college, Ugat Bhesan Road, Rander Road Near Bhestan Jakatnaka, Jahangirabad, Morabhagal, Surat, Gujarat 395004
Surat
GUJARAT
395004
India |
| Phone |
7818845477 |
| Fax |
|
| Email |
lapanidisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dharti Pansala |
| Designation |
Associate Professor |
| Affiliation |
SPB physiotherapy college |
| Address |
Department of Musculoskeletal, SPB Physiotherapy College, Ugat Bhesan Road, Nr. Mora Bhagal, Surat, Gujarat, India
Surat
GUJARAT
395005
India |
| Phone |
8141570075 |
| Fax |
|
| Email |
hingarajiadharti85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Disha Lapani |
| Designation |
post graduate student |
| Affiliation |
SPB physiotherapy college |
| Address |
musculoskeletal physiotherapy department, SPB Physiotherapy college, Ugat Bhesan Road, Rander Road Near Bhestan Jakatnaka, Jahangirabad, Morabhagal, Surat, Gujarat
Surat
GUJARAT
395004
India |
| Phone |
7818845477 |
| Fax |
|
| Email |
lapanidisha@gmail.com |
|
|
Source of Monetary or Material Support
|
| SPB Physiotherapy college,, Ugat Bhesan Road, Rander Road Near Bhestan Jakatnaka, Jahangirabad, Morabhagal, Surat, Gujarat, India, 395004 |
|
|
Primary Sponsor
|
| Name |
SPB physiotherapy college |
| Address |
Ugat Bhesan Road, Rander Road Near Bhestan Jakatnaka, Jahangirabad, Morabhagal, Surat, Gujarat 395004 |
| 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 Disha Lapani |
SPB Physiotherapy college |
musculoskeletal physiotherapy department, SPB Physiotherapy college, Ugat Bhesan Road, Rander Road Near Bhestan Jakatnaka, Jahangirabad, Morabhagal, Surat, Gujarat 395004
Surat
GUJARAT |
7818845477
lapanidisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of SPB Physiotherapy College |
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 |
Conventional Exercise |
Exercises including single and double knee to chest (for stretching and flexibility
of the back extensor and strengthening of the rectus-obliques muscles), prone lying with
pillow with one leg sliding (for strengthening the back extensor muscles), cycling in
supine (for strengthening the abdominal muscles and coordinating anterior and posterior
lumbar muscles), and bridging exercises (for strengthening back extensor muscles).(8)
The duration of session will be 10 to 15 minutes for 6 days a week and 10
repetitions of each exercise for a period of 6 weeks and a rest interval of 2 minutes
between exercises. |
| Intervention |
Feldenkrais method |
Each session will be base on the exploration of specific movements, with a focus
on increasing awareness and enhancing pain-free effective function. To enhance self-
image, habitual movement patterns will be explored in each session, guided by the
therapists verbal instructions. Participants will be directed towards body parts that are
often overlooked during movements. As Feldenkrais method work on principle of
awareness through movement, therapist will be educate the patient in certain movement
(which will difficult to do).
The duration of session will be 10 to 15 minutes. 3 session per week for period of
6 week. Conventional Exercises including single and double knee to chest (for stretching and flexibility of the back extensor and strengthening of the rectus-obliques muscles), prone lying with pillow with one leg sliding (for strengthening the back extensor muscles), cycling in supine (for strengthening the abdominal muscles and coordinating anterior and posterior lumbar muscles), and bridging exercises (for strengthening back extensor muscles). The duration of session will be 10 to 15 minutes for 6 days a week and 10 repetitions of each exercise for a period of 6 weeks and a rest interval of 2 minutes between exercises. |
| Intervention |
McGill stabilization exercises |
Patients will be perform Curl up (for training the rectus and obliques abdominis
muscles and controlling pelvic motion), Side Bridge (for training the quadratus
lumborum muscles, as a key muscle in spinal stability), Bird Dog with (for training the
anterior and posterior lumbar muscles, especially the transverse abdominis).
For each exercise there will be 3 sets, 10 repetitions with 5 seconds contraction
hold. 3 days a week for a period of 6 weeks and a rest interval of 2 minutes between
exercises. The duration of session will be 10 to 15 minutes. Conventional Exercises including single and double knee to chest (for stretching and flexibility
of the back extensor and strengthening of the rectus-obliques muscles), prone lying with
pillow with one leg sliding (for strengthening the back extensor muscles), cycling in
supine (for strengthening the abdominal muscles and coordinating anterior and posterior
lumbar muscles), and bridging exercises (for strengthening back extensor muscles).
The duration of session will be 10 to 15 minutes for 6 days a week and 10
repetitions of each exercise for a period of 6 weeks and a rest interval of 2 minutes
between exercises. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with lumbar spondylosis in x ray findings.
Persistence low back pain more than 12 weeks
Patient who able to understand either Gujarati or English.
NPRS less than 7.
ODI less than equal to 40%. |
|
| ExclusionCriteria |
| Details |
History of trauma or surgery in spine in past 3 months.
Subjects with rheumatoid arthritis, fibromyalgia, polyarthralgia or any other systemic
wide spread pain disease.
Any condition which may restrict weight on upper extremities.
Subject diagnosed with infective, neurological, cardio-pulmonary, psychosomatic
disorders.
History of cancer.
History of congenital and structural malalignments.
Professional athletes and Gymers or who engaged in sports and recreational activities.
Subjects consuming analgesics or non-surgical anti-inflammatory drugs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) NPRS for pain assessment
2) ODI for functional disability assessment
3) pressure biofeedback for core strength |
first day of treatment and after 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
20/09/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Comparative effect of McGill stabilization
exercise vs Feldenkrais method on pain,
functional disability and core strength in
patients with lumbar spondylosis:
An Experimental study
1.1 Need of the study There are no studies
available which compare the McGill stabilization exercises to the Feldenkrais method in
patient with lumbar spondylosis. There is need to evaluate specific techniques or methods
that could prove helpful in enhancing self-awareness and functional improvement while
concurrently reducing costs for patients.
1.2 Objective 1. To determine the effectiveness of McGill stabilization exercises on patient with
lumbar spondylosis in terms of pain, functional disability and core strength. 2. To determine the effectiveness of Feldenkrais method on patient with lumbar
spondylosis in terms of pain, functional disability and core strength. 3. To compare the effect of McGill stabilization exercises and Feldenkrais method on
patient with lumbar spondylosis in terms of pain, functional disability and core
strength.
1.3 Methodology 1 Study Design: A pre-post experimental study 2 Study Population: Patients with pre diagnosed lumbar spondylosis 3 Study sample: Male and female between 30-60 years of age having chronic
lumbar spondylosis 4 Sampling technique: Purposive Sampling
1.4 Inclusion criteria • Patient diagnosed with lumbar spondylosis in x ray findings. • Both males and females aged 30 to 60 years. • Persistence low back pain more than 12 weeks • Patient who able to understand either Gujarati or English. • NPRS<7, ODI≤40%
1.5 Exclusion criteria • History of trauma or surgery in spine in past 3 months. • Subjects with rheumatoid arthritis, fibromyalgia, polyarthralgia or any other systemic
wide spread pain disease. • Any condition which may restrict weight on upper extremities. • Subject diagnosed with infective, neurological, cardio-pulmonary, psychosomatic
disorders. • History of cancer. • History of congenital and structural malalignments. • Professional athletes and Gymers or who engaged in sports and recreational activities. • Subjects consuming analgesics or non-surgical anti-inflammatory drugs.
1.6 Procedure • Participants will be preliminary screened based on the inclusion and exclusion criteria. • Demographic details will be obtained from all the participants. • The purpose of the study will be explained and all the participants will be asked to sign
written informed consent. • They will be randomly allocated into three groups by chit method. GROUP A: Participants will undergo for McGill stabilization exercise and conventional
treatment GROUP B: Participants will undergo for Feldenkrais method and conventional treatment GROUP C: Participants will undergo for conventional treatment. (Control group) On the first day of the first week, baseline measurements of Pain, functional
disability, core strength will be taken. Total treatment will be of 6 weeks with 3 sessions
per week for Group A and Group B. Post assessment data of Pain, functional disability
and core strength will be taken at the end of 6 week. |