| CTRI Number |
CTRI/2024/04/066549 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| 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
|
finding the effects of dynamic neuromuscular stabilization on respiratory function , pain , balance ability and level of disability in patients suffering from low back ache due to prolapsed intervertebral disc(PIVD) |
|
Scientific Title of Study
|
Effects of Dynamic Neuromuscular Stabilization on Balance Ability, Pain, Disability, and Respiratory Function In Patients Suffering From Low Back Ache Secondary to PIVD.†|
| Trial Acronym |
PIVD- Prolapsed Intervertebral Disc |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRIYANSHI AGGARWAL(PT) |
| Designation |
PG STUDENT |
| Affiliation |
SGT University |
| Address |
D Block, Lower Ground Floor, Room number-LG-07, Department of Physiotherapy, SGT Hospital and Research Institute, Gurugram, Haryana, India 122505
Gurgaon
HARYANA
122505
India |
| Phone |
7428548670 |
| Fax |
|
| Email |
Priyanshiaggarwal28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SNIGDHA TIWARI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SGT University |
| Address |
D Block, Lower Ground Floor, Room number-LG-01, Department of Physiotherapy, SGT Hospital and Research Institute, Gurugram, Haryana, India 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9893533630 |
| Fax |
|
| Email |
SNIGDHA_FPHY@SGTUNIVERSITY.ORG |
|
Details of Contact Person
Public Query
|
| Name |
PRIYANSHI AGGARWAL |
| Designation |
PG STUDENT |
| Affiliation |
SGT University |
| Address |
D Block, Lower Ground Floor, Room number-LG-07, Department of Physiotherapy, SGT Hospital and Research Institute, Gurugram, Haryana, India 122505
Gurgaon
HARYANA
122505
India |
| Phone |
7428548670 |
| Fax |
|
| Email |
Priyanshiaggarwal28@gmail.com |
|
|
Source of Monetary or Material Support
|
| SGT Hospital and Research Institute, Gurugram, Haryana, India 122505 |
|
|
Primary Sponsor
|
| Name |
SGT Hospital and Research Institute |
| Address |
SGT Hospital and Research Institute, Gurugram, Haryana, India 122505 |
| 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 |
| Priyanshi Aggarwal |
SGT Hospital and Research Institute |
OPD number-13, Ground floor, Physiotherapy department, SGT Hospital,Gurugram ,Haryana , India, 122505
Gurgaon
HARYANA |
7428548670
Priyanshiaggarwal28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical CommitteeFPHY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M512||Other thoracic, thoracolumbar andlumbosacral intervertebral disc displacement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dynamic neuromuscular stabilisation |
Rehabilitation initially addresses the stabilization of the trunk and integrated spinal stabilization system. The core must be able to brace before movement though stabilization generally is subconscious and automatic and as a result, easily compromised and difficult to retrain. First, the patient will be taught to recognize the feeling of the right position versus the compromised stabilization. This is followed by the ability to hold the optimal stabilization posture in different positions and finally during movement. (Kobesova A et al 2014) it includes
1. Neutral Chest Position and Correct Breathing Stereotype:
2. Supine 3-month position
3. Prone 3-month position
4. Side lying 5-month position
5. 7-month oblique sitting position with forearm support
6. 8-month, all fours (quadruped) position:
|
| Comparator Agent |
lumbar stabilisation |
Group b received conventional lumbar stabilization exercises along with a Moist heat pack for 15 minutes before the treatment.
Exercise includes:
1. Spinal isometrics exercise
2. Bridge - In the prone position, the participant flexed both knees and elevated the pelvis to align with the thighs.
3. Superman: In the prone position, the participant raised both arms and legs.
4. Bird dog: Starting from a four-legged pose, participants lifted one arm and extended the opposite leg parallel to the floor. After maintaining this position for 5 seconds, they repeated the movement on the other side.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 18-60 years.
2. Both male and female participants.
3. Clinically diagnosed patients with PIVD
4. Complaints of LBP with NPRS 5 and above.
5. Non-smoker
|
|
| ExclusionCriteria |
| Details |
1. Patients complaining of lumbar pain with a history of spinal surgery.
2. Patients with other specific diagnoses (e.g., Myelopathy, TB of the spine, Fracture, Dystonia, Malignancy, Osteoporosis, and Fibromyalgia)
3. Patients with current pregnancy or early postpartum period.
4. Patients with any breathing disorder ( e.g., COPD , TB etc)
4. Incompletely worked-up cases.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain
2. Balance ability
3. Respiratory function
4. Disability
|
BASELINE AND 4TH WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to calculate fvc/fev1 ratio specific to PIVD |
after baseline measurment |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/05/2024 |
| Date of Study Completion (India) |
08/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study Aims to see the Effects of dynamic neuromuscular stabilization on balance ability, pain, respiratory function, and disability in patients suffering from low back pain secondary to PIVD.The study utilized a Pretest Posttest Control group design over a 4-week period at the Physiotherapy OPD of SGT Medical College, hospital, and research institute in Gurugram, Delhi, NCR. Ethical approval was obtained from the Departmental Ethical Committee of the Faculty of Physiotherapy at SGT University. A sample size of 33 patients, including a 10% dropout rate, was calculated using G power version, with participants selected through convenience sampling for easy accessibility. Inclusion criteria comprised individuals aged 18-60, clinically diagnosed with PIVD, experiencing lower back pain (NPRS 5 and above), and non-smokers, while exclusion criteria included those with a history of spinal surgery, specific diagnoses, pregnancy or early postpartum period, breathing disorders, and incompletely worked-up cases. Dependent variables encompassed pain, balance ability, respiratory function, and disability, while the independent variable was Dynamic Neuromuscular Stabilization. |