| CTRI Number |
CTRI/2023/08/056228 [Registered on: 07/08/2023] Trial Registered Prospectively |
| Last Modified On: |
09/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two different exercise training programme on reducing pain and movement fear and to improve quality of life in patients with long term low back pain |
|
Scientific Title of Study
|
Comparison of Dynamic Neuromuscular Stabilization along with Lumbar Stabilization Exercise and Lumbar Stabilization Exercise alone on Pain, Kinesiophobia and Quality of life in patients with Chronic Non-specific Low Back Pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Loka Janani |
| Designation |
Postgraduate Student |
| Affiliation |
Kovai Medical Center and Hospital College of Physiotherapy |
| Address |
Room number:019
Orthopedic-Physiotherapy Division
Orthopedics Physiotherapy Department
Kovai Medical Center and Hospital College of Physiotherapy
Kalapatti post
Coimbatore 641048
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9361399438 |
| Fax |
|
| Email |
slokajananipt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
J Prakash |
| Designation |
Professor in MPT Orthopedics |
| Affiliation |
Kovai Medical Center and Hospital College of Physiotherapy |
| Address |
Room number:019
Orthopedic-Physiotherapy Division
Orthopedics Physiotherapy Department
Kovai Medical Center and Hospital College of Physiotherapy
Kalapatti post
Coimbatore 641048
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9944087135 |
| Fax |
|
| Email |
prakashjayabalan4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Loka Janani |
| Designation |
Postgraduate Student |
| Affiliation |
Kovai Medical Center and Hospital College of Physiotherapy |
| Address |
Room number:019
Orthopedic-Physiotherapy Division
Orthopedics Physiotherapy Department
Kovai Medical Center and Hospital College of Physiotherapy
Kalapatti post
Coimbatore 641048
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9361399438 |
| Fax |
|
| Email |
slokajananipt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number:019
Ortho- Physiotherapy Division
Orthopedics Physiotherapy Department
KMCH College of Physiotherapy
Kalapatti post
Coimbatore 641048 Tamilnadu |
|
|
Primary Sponsor
|
| Name |
KMCH Institute of Health Sciences and Research |
| Address |
KMCH Institute of Health Sciences and Research
Coimbatore
641048 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 S Loka Janani |
Kovai Medical Centre and Hospital (KMCH) |
Kovai Medical Centre and Hospital
Orthopedic Division
Orthopedic Physiotherapy Department
Coimbatore
641014
Coimbatore
TAMIL NADU |
9361399438
slokajananipt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCH INSTITUTE OF HEALTH SCIENCES AND RESEARCH - INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M539||Dorsopathy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dynamic neuromuscular stabilization exercises along with Lumbar Stabilization exercises |
Physiotherapy education will be given to the patient on the first day of the assessment. By the second day, patient will perform Dynamic neuromuscular stabilization exercises along with lumbar stabilization exercise. Total duration of the intervention is 4 weeks, 5 days per week, 1 session per day, 1 Hour per session, Totally 20 sessions. |
| Comparator Agent |
Lumbar Stabilization Exercises |
Physiotherapy education will be given to the patient on the first day of the assessment. By the second day, patient will perform lumbar stabilization exercises alone. Total duration of the intervention is 4 weeks, 5 days per week, 1 session per day, 1 Hour per session, Totally 20 sessions. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Low back pain for more than 3 months.
2. Low back pain patients with the NPRS Score: 4-8
3. Patients with Low back pain without any other specific pathology confirmed by the Orthopaedician by clinical examination or CT scan or MRI scan.
4. Low back pain patients with the age group – 35 to 50 years.
5. Both male and female patients.
6. Stable medical condition to allow participation in the intervention and testing protocol.
7. Patients with the ability to understand and follow the therapist instructions.
8. Low back pain patients in the geographic area - Coimbatore city. |
|
| ExclusionCriteria |
| Details |
1. Low Back Pain with specific pathology. (eg, infection, tumour, osteoporosis, lumbar spine fracture, structural or congenital deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome)
2. Patients with the history of recent spinal surgery or other surgeries which interrupts the exercise training or worsens the patient‘s condition.
3. Pregnant women.
4. Patients with Neurological problem or other musculo-skeletal conditions which interrupts the exercise training or worsens the patient‘s condition.
5. Patients with metal implant.
6. Patients with rheumatoid disorders.
7. Patients with unstable cardiac conditions. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain |
Baseline- before commencing the treatment
Post test- at the end of 4th week of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Kinesiophobia
|
Baseline- before commencing the treatment
Post test- at the end of 4th week of treatment |
| Quality of life |
Baseline- before commencing the treatment
Post test- at the end of 4th week of treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
10/08/2023 |
| 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)
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 - NO
|
|
Brief Summary
|
Non-speciï¬c low back pain is deï¬ned as low back pain (LBP) not attributable to a recognizable, known speciï¬c pathology (eg, infection, tumour, osteoporosis, lumbar spine fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome). Non-specific low back pain is usually categorized in 3 sub-types: acute, sub-acute and chronic low back pain. This sub-division is based on the duration of the back pain. Chronic low back pain lasts for 12 weeks or more. Most cases are non-specific, but in about 10% of cases a specific cause is identified. LBP has been found to have chronic widespread pain.
Non-specific low back pain accounts for more than 90% of episodes. It usually affects people aged 20–55 years. 80 % of the population is affected by this symptom at sometime in life. Impairments of back and spine are ranked as the most frequent cause of limitation of activity in people younger than 45 years. For 78 % men and 89 % women, specific cause was not known. It was believed that bad posture was responsible for most of these cases. All age groups can be affected by non-specific low back pain. But the impact on quality of life is lower in adolescents than in adults. Low back pain is more common in heavy manual workers, particularly those in occupations that involve heavy lifting and twisting. Psychological factors (e.g. job dissatisfaction, depression, anxiety) are important risk factors for both acute back pain and the transition to chronic pain and disability.
Interventions of the study are Dynamic Neuromuscular Stabilization (DNS) and Lumbar Stabilization Exercises (LSE) .
Dynamic Neuromuscular Stabilization (DNS) is an evolving concept in the field of rehabilitation. It is used successfully for the rehabilitation of various neurological, musculoskeletal, paediatric and sports injury cases. But only fewer studies have shown the effect of DNS on Low Back Pain.
Lumbar Stabilization Exercises (LSE) has become a popular treatment for low back pain. LSE are commonly used to improve lumbar stability and increase trunk muscle strength.
To date, no studies compares the combined effectiveness of dynamic neuromuscular stabilization along with lumbar stabilization exercise and lumbar stabilization exercise alone on pain, kinesiophobia and quality of life in patients with chronic non-specific low back pain.
Hence, the need for the study is to compare the combined the effectiveness of dynamic neuromuscular stabilization along with lumbar stabilization exercise and lumbar stabilization exercise alone on pain, kinesiophobia and quality of life in patients with chronic non-specific low back pain.
The primary objective of the study is to evaluate the combined effectiveness of dynamic neuromuscular stabilization along with lumbar stabilization exercise and lumbar stabilization exercise alone on pain by using Numerical Pain Rating Scale (NPRS) in patients with Chronic non-specific low back pain among 2 groups. Secondary objectives of the study is to evaluate the combined effectiveness of dynamic neuromuscular stabilization along with lumbar stabilization exercise and lumbar stabilization exercise alone on kinesiophobia and quality of life by using Tampa Scale of Kinesiophobiasis (TSK – 11) and World Health Organization Quality of Life Scale (WHO QOL – BREF) in patients with Chronic non-specific low back pain among 2 groups.
60 patients with Chronic non-specific low back pain who fall under inclusion and exclusion criteria will be recruited from orthopedics and physiotherapy department through purposive sampling technique. Then the subjects will be divided into two groups, group A (30) and group B (30) by lottery method. Group A will be receiving Dynamic neuromuscular stabilization exercises along with lumbar stabilization exercises and Group B will be receiving Lumbar stabilization Exercises alone. The demographic details of the participants will be collected and pre test evaluation of the following domains will be recorded by the principal investigator: 1. Pain by using Numerical Pain Rating Scale (NPRS) 2. Kinesiophobia by using Tampa Scale of Kinesiophobiasis (TSK – 11) 3. Quality of life by using World Health Organization Quality of Life Scale (WHO QOL – BREF)
At the end of 4th week, the post test evaluation will be done to measure the variables. |