| CTRI Number |
CTRI/2024/09/073685 [Registered on: 10/09/2024] 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, Active Controlled Trial |
|
Public Title of Study
|
Impact of Foot Correction Exercises on Low Back Pain and Function: A Study on Patients with Non-Specific Low Back Pain |
|
Scientific Title of Study
|
Effect of flexible flat foot correction exercise on pain and function in patients with chronic non-specific low back pain: 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 |
KHUSHI VIRANI |
| Designation |
Post Graduate Student |
| Affiliation |
SPB Physiotherapy College |
| Address |
OPD 1 and 4, Department of musculoskeletal physiotherapy,Ugat bhesan road, Morabhagal,rander road, Surat
Surat
GUJARAT
395005
India |
| Phone |
9727508940 |
| Fax |
|
| Email |
khushivirani2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Neeti Mishra |
| Designation |
Professor |
| Affiliation |
SPB Physiotherapy College |
| Address |
OPD 1 and 4, Department of musculoskeletal physiotherapy,Ugat bhesan road, Morabhagal,rander road, Surat
Surat
GUJARAT
395005
India |
| Phone |
9879697384 |
| Fax |
|
| Email |
dr.neetimishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KHUSHI VIRANI |
| Designation |
Post Graduate Student |
| Affiliation |
SPB Physiotherapy College |
| Address |
OPD 1 and 4, Department of musculoskeletal physiotherapy,Ugat bhesan road, Morabhagal,rander road, Surat
Surat
GUJARAT
395005
India |
| Phone |
09727508940 |
| Fax |
|
| Email |
khushivirani2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| SPB Physiotherapy College
Ugat bhesan road, Morabhagal,rander road, Surat,Gujarat,India,395005 |
|
|
Primary Sponsor
|
| Name |
SPB Physiotherapy College |
| Address |
OPD 1 and 4, Department of musculoskeletal physiotherapy ,Ugat bhesan road, Morabhagal,rander road, Surat,Gujarat,India, 395005 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Khushi Virani |
SPB Physiotherapy College |
OPD 1 and 4, Department of musculoskeletal physiotherapy ,Ugat bhesan road, Morabhagal,rander road, Surat
Surat
GUJARAT |
09727508940
khushivirani2000@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: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional physiotherapy for non-specific low back pain |
Hot Pack for 10 mins
Static back exercise- (10 repetitions; 5 days per week for 4 weeks)
Static abdomen exercise- (10 repetitions; 5 days per week for 4 weeks)
Single and double knee to chest (10 repetitions; 5 days per week for
4 weeks)
Cycling in supine
Bridging exercises (10 repetitions; 2 set; 5 days per week for 4
weeks)
|
| Intervention |
Flat foot correction exercises |
Calf stretching in long sitting position for 3 repetitions, 30 sec holds,for 5 days per week for 4 weeks.
Short foot exercises :10 repetitions,5 sec hold for 2 sets/ day, for 5 days per week for 4 weeks; Patient initially initiates in sitting position then progress to double stance position and then to single stance position. Patient with be in normal relaxed sitting position and feet on floor, then they were asked to form medial arch by slightly lifting medial aspect of foot. Similarly, then exercise is performed in standing with double stance and later to single stance.
Concentric foot exercises (10 repetition; 2 sets; 5 days a week for 4 weeks): concentric dorsiflexion with manual resistance (in long sitting); inversion of the foot with manual resistance (in long sitting); Towel curling exercises (sitting on chair) (figure 3); Heel raises with ball (stand straight with ball placed between the malleoli) (figure 4).
Eccentric foot exercises: (10 repetition; 2 sets; 5 days a week for 4 weeks): eccentric dorsiflexion with manual resistance (in long sitting); eccentric inversion of the foot with manual resistance (in long sitting).
Hot Pack for 10 mins
Static back exercise- (10 repetitions; 5 days per week for 4 weeks)
Static abdomen exercise- (10 repetitions; 5 days per week for 4 weeks)
Single and double knee to chest (10 repetitions; 5 days per week for
4 weeks)
Cycling in supine
Bridging exercises (10 repetitions; 2 set; 5 days per week for 4
weeks)
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient referred with clinically diagnosed chronic mechanical LBP.
Patient having low back pain more than 3 months.
Patient having flexible flat foot (Navicular drop- more than equal to 10 mm)
Disability- mild to moderate disability (score-0 to 24)
|
|
| ExclusionCriteria |
| Details |
History of any surgery especially lower limb, trunk and foot in last 6 months.
History of any congenital cardiovascular disease.
History of any systemic disease.
History of any recent infectious disease in patients.
History of trauma or other accident relating to injury.
History of any neurological disease (cauda equina syndrome) or radiculating pain.
Back pain that is brought on by ankylosing spondylitis, cancer, sepsis, and fractures.
Patient with complain of radiculating pain in lower extremity.
Patient with fixed flat foot.
Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oswestry Disability Index (ODI)
Numerical Pain Rating Scale (NPRS) |
0 day and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Navicular Drop Test (NDT) |
0 day and 28th day |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
16/09/2024 |
| 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
|
EFFECT OF FLEXIBLE FLAT FOOT CORRECTION EXERCISE ON PAIN AND FUNCTIONS IN PATIENTS WITH CHRONIC NON-SPECIFIC LOW BACK PAIN: AN EXPERIMENTAL STUDY 1.1 Significance for the study: In the patient with chronic non specific low back pain there is effect of podiatrical deviations such as flat feet, ankle instability, and hallux valgus deformity. As in flexible flat foot there is decrease in medial longitudinal arch (MLA) which leads to many biomechanical alterations which would in turn increase strain over back and abdominal muscles giving rise to pain persistence for prolong period which can further lead to disability. Many studies had showed correlation and prevalence of low back pain with flat foot. So, this study will help in introducing protocol for correction of flexible foot via flat foot correction exercises and it may help in reducing pain and improve functions in patients having Chronic Non-Specific Low Back Pain. 1.2 Objectives of the present study To evaluate the effect of conventional therapy exercises on pain and functions in patients with chronic non-specific low back pain. To evaluate the effect of flexible flat foot correction exercises along with conventional therapy exercises on pain and functions in patients with chronic non-specific low back pain. To compare effect of flexible flat foot correction exercises along with conventional therapy exercise v/s conventional exercises on pain and functions in patients with chronic non-specific low back pain. 1.3 Procedure: - The patient will be selected according to inclusion and exclusion criteria. Further consent form will be provided and complete details about study will be explained and patient assessment sheet containing demographic data will be filled. After selection of patients, they will be randomly allocated to two groups by using lottery method. Here: · Group A-Conventional Therapy for Non-Specific Low Back Pain · Group B Conventional Therapy for Non-Specific Low Back Pain + Flexible Flat foot correction exercises. Baseline assessment for Non-Specific Low Back Pain (NSLBP) will be done by Numerical Pain Rating Scale (NPRS) and functional evaluation will be done by Oswestry Disability Index (ODI) and flexible flat foot will be assessed by Navicular Drop Test (NDT). After 4 weeks of intervention again assessment for Non-Specific Low Back Pain (NSLBP) by NPRS and functional evaluation will be done by ODI. |