| CTRI Number |
CTRI/2025/04/084035 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| 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
|
comparing two treatment for back pain |
|
Scientific Title of Study
|
To compare the effectiveness of dynamic neuromuscular stabilization and Pilates on non-specific chronic 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 |
Lipika Aggarwal |
| Designation |
MPT student |
| Affiliation |
Gurugram University |
| Address |
Department of physiotherapy ,Gurugram university sec- 87 kakrola village gurugram.
Gurgaon
HARYANA
122505
India |
| Phone |
8168462705 |
| Fax |
|
| Email |
lipikaaggarwal03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gurpreet Singh |
| Designation |
Assistant Professor |
| Affiliation |
Gurugram University |
| Address |
Deartment of physiotherapy gurugram university sec- 87 kakrola village gurugram.
Gurgaon
HARYANA
122505
India |
| Phone |
9350567096 |
| Fax |
|
| Email |
physio11r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lipika Aggarwal |
| Designation |
MPT Student |
| Affiliation |
Gurugram University |
| Address |
Department Of Physiotherapy Gurugram University sec- 87 Kakrola village, Gurugram.
Gurgaon
HARYANA
122505
India |
| Phone |
9350567096 |
| Fax |
|
| Email |
lipikaaggarwal03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy, Gurugram University , sec-87 , Kakrola, gurugram pin code-122505, haryana |
|
|
Primary Sponsor
|
| Name |
Gurugram University |
| Address |
Department of Physiotherapy Gurugram University sec- 87 Kakrola village Gurugram pincode-122505. |
| Type of Sponsor |
Other [Gurugram University] |
|
|
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 |
| lipika aggarwal |
Quality Physio Advanced chiropractor physiotherapy |
Quality Physio Advanced chiropractor physiotherapy,2nd floor, plot no. 2 road opp. Vega school, Aron Ville Dhani , Fazilpur Jharsa sec-48,Gurugram , Haryana 122108
Gurgaon
HARYANA |
8168462705
lipikaaggarwal03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R299||Unspecified symptoms and signs involving the nervous and musculoskeletal systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dynamic neuromuscular stabilization |
Group A: (DNS Group) give treatment with Dynamic Neuromuscular Stabilization with conventional therapy The exercises for this group were structured as follows: the DNS groups protocol consisted of a 5-minute warm-up [ankle pump] movts, 40 minutes of DNS movements combined with breathing exercises, and a 5-minute cool-down[relaxation and stretching]. As per the DNS method, the exercises involved.
diaphragmatic breathing,
Baby Rock (supine 90–90),
Prone, Rolling,
Side Lying,
Oblique Sit,
Tripod, Kneeling, Squat and Czech Get Up
|
| Comparator Agent |
pilates |
Group B:(Pilates group) will receive pilates exercises with CPT for the same duration. Exercises for this group are as follow :
Single leg stretch
Double leg stretch
Leg floats
Bridging
Roll up
Pelvic curls
Exercises will done with breathing and conventional therapy
Pilates training will be conducted for 6 weeks, three times a week, with each session lasting about an hour. In each session, a 5-minute warm-up and preparation procedure will be performed first. At the end, stretching and walking will be done to return to the baseline condition. Four extension-type exercises and two flexion-type exercises will be included. The extension-type exercises will be performed in prone positions, and the flexion-type exercises will be done in supine positions. Each exercise will be performed ten times.
Each exercise is for 6 min40 secs and 10 reps and 15sec hold 1 min relaxation between exercise and 40 secs for changeing
10 mins of IFT total duration is 60 mins.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
patient is suffering from musculoskeletal chronic low back pain
patient age from 18 to 45 years is included
patient willing to sign the Informed consent
patient referred by orthopedician is included
patient with Non- specific chronic low back pain for more than 3 months is included
Patient will be Male and female.
|
|
| ExclusionCriteria |
| Details |
patient with any cardiopulmonary condition
patient is a having degenerative disease, inflammatory condition and any specific cause of low back pain
patient is having metallic implants in body
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
pain intensity
functional disability |
baseline after 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| abdominal muscle strength |
baseline after 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 2 |
|
Date of First Enrollment (India)
|
13/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="21" |
|
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
|
Low back pain, generally described as pain located below the ribcage and above the lower buttocks, with or without accompanying leg pain, is the most common and disabling condition globally that is believed to benefit from rehabilitation •Although several studies have investigated the effectiveness of Dynamic neuromuscular stabilization and Pilates individually, there is a paucity of research directly comparing their efficacy in Low back pain management. A comparative study would provide valuable insights into the relative benefits of Dynamic neuromuscular stabilization and Pilates, enabling clinicians to make informed decisions about treatment recommendations for individuals with Non specific chronic low back pain. In past couple of years there has been high reporting of cases with low back pain in the Physiotherapy our OPD from nearby locality. There is a paucity of research directly comparing the Dynamic neuromuscular stabilization and Pilates .This comparative study would provide valuable insight into the relative benefits of Dynamic neuromuscular stabilization and Pilates , enabling clinicians to make informed decision about the treatment recommendations for individuals with Nonspecific chronic low back pain Although several studies have investigated the effectiveness of Dynamic neuromuscular stabilization and Pilates individually, there is a paucity of research directly comparing their efficacy in Low back pain management. A comparative study would provide valuable insights into the relative benefits of Dynamic neuromuscular stabilization and Pilates, enabling clinicians to make informed decisions about treatment recommendations for individuals with Non specific chronic low back pain. In past couple of years there has been high reporting of cases with low back pain in the Physiotherapy our OPD from nearby locality. There is a paucity of research directly comparing the Dynamic neuromuscular stabilization and Pilates .This comparative study would provide valuable insight into the relative benefits of Dynamic neuromuscular stabilization and Pilates , enabling clinicians to make informed decision about the treatment recommendations for individuals with Nonspecific chronic low back pain |