| CTRI Number |
CTRI/2024/07/070080 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Spinal Stabilization Exercises to Reduce Pain and Improve Kyphotic Posture in Women after Delivery
|
|
Scientific Title of Study
|
Effectiveness of Spinal Stabilization Exercises on Musculoskeletal Pain and Posture Among Postpartum Women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhavi dholiya |
| Designation |
Post Graduation Student |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical Sciences and Allied Health Sciences. |
| Address |
Room No. 4, Department of Physiotherapy, North Block Basement, Shri Mahant Indiresh Hospital. Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8160796925 |
| Fax |
|
| Email |
madhavidholiya20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Tabassum Azmi |
| Designation |
Assistant Professor |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical Sciences and Allied Health Sciences. |
| Address |
Room no. 4, Department of Physiotherapy, North Block Basement, Shri Mahant Indiresh Hospital. Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9340473424 |
| Fax |
|
| Email |
drtabassumazm22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Tabassum Azmi |
| Designation |
Assistant Professor |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical Sciences and Allied Health Sciences. |
| Address |
Room no. 4, Department of Physiotherapy, North Block Basement, Shri Mahant Indiresh Hospital. Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9340473424 |
| Fax |
|
| Email |
drtabassumazm22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Guru Ram Rai University, School of Para Medical and Allied Health and Sciences, Pathribag, Dehradun, Uttaranchal. 248001 |
|
|
Primary Sponsor
|
| Name |
Madhavi Dholiya |
| Address |
Room no. 3, Physiotherapy department. Shri Guru Ram Rai University, School of Paramedical and Allied Health and Sciences, Pathribag, Dehradun, Uttaranchal. 248001 |
| 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 |
| Dr Tabassum Azmi |
Shri Mahant Indiresh Hospital |
Department of Physiotherapy, North Block Basement, Shri Mahant Indiresh Hospital, Dehradun
Dehradun
UTTARANCHAL |
9340473424
drtabassumazm22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) SHRI GURU RAM RAI INSTITUTE OF MEDICAL & HEALTH SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Stretching and Strengthening Exercises |
The given stretching exercises are as follows:
1. Gluteal stretch
2. Piriformis Stretch
3. Iliopsoas stretch
4. Scalene Stretch
5. Trapezius Stretch
6. Pectoralis major and minor stretch.
Each stretching exercises will be given for 3 days per week for 8 weeks. With 3 Repetition and 30 seconds hold and 10 seconds rest in between the sets.
The given Strengthening Exercises will be as follows:
1. Static back
2. Static Glutes
3. Cat and Camel
4. Chin Tuck
5. Bird dog
6. Pelvic Tilt
7. Trunk rotation
8. Pelvic Bridging
9. Crunches
Each exercises will be given for 10 Repetition with 10 seconds hold. 3 days in a week for 8 weeks.
Number of Repetition and set will be increased on weekly basis.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Kyphotic Posture and related musculoskeletal pain such as knee pain, upper back pain, lower back pain, neck pain and pelvic pain or aged 20 to up to 40 years and should be within 6 months to 3 years post-delivery and whether they are primigravida (first-time mothers) or multigravida (have had multiple pregnancies), and have experienced either vaginal or cesarean section deliveries, |
|
| ExclusionCriteria |
| Details |
Patients who have experienced severe trauma during childbirth, such as a coccyx fracture, or suffer from ankylosing spondylitis, significant lower limb-length discrepancy, acute inflammation or infectious diseases like osteomyelitis or septic arthritis, or have a history of previous spinal and pelvic fractures, require specialized medical attention to address their complex health needs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical Pain Rating Scale for Accessing Pain Level. |
1st day, 29th day, 58th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Flesche test |
1st Day, 29th Day, 58th Day |
| Oswestry Low Back Disability Questionnaire For assessing lower back disability |
1st Day, 29th Day, 58th Day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
Modification(s)
|
Phase 1 |
|
Date of First Enrollment (India)
|
16/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A specific rehabilitation program, including spinal stabilization exercises and stretching exercises,
after pregnancy can effectively strengthen abdominal, back, and pelvic muscles,
thereby improving posture, increasing weight-bearing ability, significantly
reducing pain, and enhancing overall quality of life. Spine stability is primarily managed by the local muscles, whereas the
global muscles, which are generally multisegmented, are the primary producers
of movement and it’s also provided Therapeutic effect for musculoskeletal pain
and posture |