| CTRI Number |
CTRI/2024/05/067852 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| 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
|
Comparing traditional therapy to bilateral hip muscle strengthening for students experiencing non specific low back pain |
|
Scientific Title of Study
|
Comparison of bilateral hip muscle strengthening with conventional therapy in students with non-specific chronic low back pain: A Randomized Controlled 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 |
Lucky Khandelwal |
| Designation |
Post graduate student |
| Affiliation |
NITTE Institute of Physiotherapy, NITTE (Deemed to be university) |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
8233247011 |
| Fax |
|
| Email |
luckykhandelwal47011@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Saumya Srivastava |
| Designation |
Associate Professor |
| Affiliation |
NITTE Institute of Physiotherapy, NITTE (Deemed to be university) |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9740244077 |
| Fax |
|
| Email |
saumyasri2000@nitte.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Lucky Khandelwal |
| Designation |
Post graduate student |
| Affiliation |
NITTE Institute of Physiotherapy, NITTE (Deemed to be university) |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
8233247011 |
| Fax |
|
| Email |
luckykhandelwal47011@gmail.com |
|
|
Source of Monetary or Material Support
|
| NITTE Institute of Physiotherapy, NITTE (Deemed to be unversity) will provide basic infrastructure facilities. no other monitary support is required |
|
|
Primary Sponsor
|
| Name |
Nitte Institute of Physiotherapy NITTE deemed to be university |
| Address |
Department of Physiotherapy, room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, 575018, India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Lucky Khandelwal |
Nitte Institute of Physiotherapy |
Room number 20, Department of Physiotherapy,second base division , Justice K.S. Hedge Charitable Hospital, Deralakatte, Mangaluru Dakshina Kannada KARNATAKA |
8233247011
luckykhandelwal47011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of NITTE Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physical therapy |
The patients will perform an average of three series of 10 repetitions of each exercise. For all exercises, the final static position will be held for 8 sec. There will be a pause of 3 seconds between repetitions and a 60-sec rest between each exercise, there will be an increase in the number of repetitions or load progression according to individual tolerance. A single session will take 30 minutes to complete, treatment will be given for 3 times in a week for 4 weeks.
1) Traditional curls up
2) Single Knee to chest
3) Bridging
4) Prone on elbow
5) Prone on hands
6) Prone hip extension
7) Trunk extension
|
| Intervention |
Hip strengthening protocol |
Exercises will be performed for a frequency of 3 sets of 10 repetitions for each side hold for 10 seconds, and there will be increase in the number of repetitions or load progression according to individual tolerance.A single session will take 45 minutes to complete, treatment will be given 3 times in a week for 4 weeks.
1) Clam shell with resistance band
2) Side lying hip abduction with resistance band
3) Squat with resistance band
4) Lateral stepping with resistance band
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
1) University students of various institutions under Nitte Deemed to be university
2) Age 18-28 years old
3) Nonspecific chronic low back pain
4) Pain intensity on NPRS with a score between 3 to 8
5) BMI range of 18.4 – 24.9 |
|
| ExclusionCriteria |
| Details |
1) Participants with a history of trauma or surgery to the lumbar spine, abdomen,
pelvis, or lower limb in the past 1 year
2) Participants reporting spinal deformity (scoliosis, spondylolysis, spondylolisthesis,
spinal stenosis, or PIVD)
3) Participants with a history of spinal and pelvis fracture in the past 3 months
4) Participants who are taking corticosteroids or anti-inflammatory medication
currently
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pull and Push Dynamometer, Numeric Pain Rating Scale |
Once the individual is included in the study, readings will be taken as baseline values and after 4 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Oswestry Disability Scale,
Single Leg stance test |
Once the individual is included in the study, readings will be taken as baseline values and after 4 weeks of treatment. |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Nonspecific low back pain (NSLBP) is described as low back discomfort with no discernible, well-known pathophysiology, that is not caused by a specific condition. Many diagnoses by researchers have led to the conclusion that no important reason or disease is causing NSLBP. Pain in the lower back region might be caused by lifting large weights by age-related changes in the spine over time or by prolonged sitting in faulty posture in front of laptops or mobiles. Students attend classroom sessions for theory input while also working in front of computers to search for materials, which requires prolonged sitting in most of their everyday activities. Prolonged sitting has become one of the factors causing musculoskeletal discomfort, particularly among university students who have LBP, which is often reported and highly connected with individual variables, work ergonomics, and incorrect posture and mobility. Postural pain is the pain caused by mechanical tension when a person maintains a bad posture for an extended period; the pain is usually eased by movement. There are no functional strength or flexibility limitations, but if the poor posture persists, strength and flexibility imbalances emerge. Chronic NSLBP patients experience pain, muscle atrophy, decrease in muscle strength, endurance, and flexibility these all occur as a result of the long-term reduction in trunk activity and disuse, which aggravates low back pain and causes secondary lumbar segment damage and physical disability. When compared to healthy people, those suffering from low back pain have less capacity to maintain balance. When the human body is subjected to an unexpected load, the muscles should respond quickly to maintain balance and posture against the load, but 3 patients with low back pain have a delayed response time, causing a problem with balance. The prevalence of low back pain among university students is particularly significant due to their prolonged sitting with laptops and mobile phones in poor posture. Many factors influence low back pain in university students, including anthropometric data in individual’s twenties, physiological structure, genetic factors, age, gender, smoking, computer work duration, lumbar support usage, school furniture, sitting position, physical activity, and socioeconomic situations. Studies that have evaluated the hip muscles in chronic NSLBP patients found that there is a significant weakness in hip abductors, adductors, and extensors compared to healthy individuals, which increases the need for administrating the hip muscle strengthening protocol in the physical therapy protocols normally used. Some studies have used the hip strengthening protocol with other conventional therapies they have only targeted the hip abductors and extensors and concluded that the group with the hip strengthening protocols was having better and significant improvement in strength, pain disability, and balance but the population taken was of age 30-50 years of age. There is a clear gap in the literature to test the effectiveness of hip strengthening protocol for non-specific chronic low back pain in the student population. This study aims to compare bilateral hip muscle strengthening with conventional treatment in students with chronic NSLBP. We hypothesized that the addition of hip strengthening exercises to a conventional exercise would result in an increase in strength, a reduction in pain and disability, and improved balance ability. The test components included will be hip muscle strength measurement using a dynamometer with a reliability of 0.98. The numeric pain Rating Scale (NPRS) consisted of 11 points; it exhibits moderate reliability ICC = 0.67; (0.27 – 0.84]. [4] To determine the level of disability caused by LBP, the Oswestry disability index (ODI) is utilized. The ICC value of ODI is 0.93. The single-leg standing test is used to assess LBP patients’ static balance skills. The suggested single-leg stance balancing test is a valid technique for evaluating balance. |