| CTRI Number |
CTRI/2025/01/079351 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [The study intervention also use combined physiotherapy exercises and Yoga asanas(Physioyoga) ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Physioyogic exercises in non-specific low back pain among post menopausal women |
|
Scientific Title of Study
|
Integrating physioyogic exercises in non-specific low back pain among post menopausal women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riya Sirari |
| Designation |
PG Scholar |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125 Noida Uttar Pradesh (201313)
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8920420199 |
| Fax |
|
| Email |
riyasirari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rabab Kaur |
| Designation |
Assistant Professor Grade 1 |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125 Noida Uttar Pradesh (201313)
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9654478155 |
| Fax |
|
| Email |
rkaur4@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rabab Kaur |
| Designation |
Assistant Professor Grade 1 |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125 Noida Uttar Pradesh (201313)
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9654478155 |
| Fax |
|
| Email |
rkaur4@amity.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125 Noida 201313 Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Riya Sirari |
| Address |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125 Noida Uttar Pradesh (201313) |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Riya Sirari |
Amity Institute of Health Allied Sciences |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, F1 LGF Sector 125 Noida 201313
Gautam Buddha Nagar
UTTAR PRADESH |
8920420199
riyasirari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Department of Physiotherapy Amity Institute of Health Allied Sciences, Amity University, Noida, Uttar Pradesh |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Core Stabilization exercises |
The core stabilization exercise session will be for 3 days in one week. The total duration of intervention will be 6 weeks. The core stabilization intervention include 4 exercises- spinus multifidus exercise(bird dog),straight leg raise from prone, pelvic floor exercises and abdominal hollowing. The core stabilization session will be for 30 minutes and it consist of exercises having 1 set of 10 repetitions containing 7-8 seconds hold except pelvic floor exercises(long holding and quick squeeze) that include 5 repetitions each of 6 seconds hold followed by 6 seconds relaxation. Patient will be provided 1 minute rest in between the exercises and 3 seconds rest in between repetitions. |
| Intervention |
Physioyoga(core stabilization in addition to yoga asanas) |
The total duration of Physioyoga intervention will be 6 weeks with 3 days session in one week. The intervention combines the core stabilization and Yoga asanas having specific dosage. The dosage for core stabilization- 1 set of 5 repetitions of only 4-5 seconds hold. The yoga session dosage is- 2 sets of 2 repetitions of 8 seconds hold. The yoga asanas include: Supta Udarakarshanasana, Supta Pavan muktasan, Ustrasana, Shavaudarakarshanasana.The yoga asanas stretches the torso and help in improving the mobility of lumbar spine.
|
|
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Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1)Women with chronic non-specific low back pain(more than six
months)
2) Post-menopausal females from age 45-55 years
3) Subjects able to practice yoga or exercise protocols
4) Lack of specific illness such as neurologic
disease,Cancer,Diabetes
5) Participants willing to participate
6) NPRS is more than or equal to 4
7) Pain primarily in the lower back symptoms increases with
flexion of the back and when lifting heavy objects.
8) Women include housewives and working |
|
| ExclusionCriteria |
| Details |
1)Pregnancy
2)Renal Pathology
3)Patients having acute low back pain, a history of spinal infection, fracture or malignancy and cardiac disorders, evidence of sacroiliac joint and hip joint dysfunction, or neurological deficit.
4)Undergoing Hormone Replacement Therapy.
5)Clinically diagnosed psychiatric problem.
6)Use of walking aids.
7)History of surgery in the past one year.
8)Currently receiving physiotherapy treatment or participating in Yoga training |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain with non-specific low back pain |
Baseline assessment- before intervention
Follow up assessment- after 3 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional disability associated with non-specific low back pain |
Baseline assessment- before intervention
Follow up assessment- after 3 days of intervention |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
02/02/2025 |
| 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="0"
Months="4"
Days="0" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [riyasirari@gmail.com].
- For how long will this data be available start date provided 15-06-2025 and end date provided 14-05-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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Brief Summary
|
Post menopausal phase is a potential cause for higher prevalence of low back pain in women. Various studies analysis showed that women who experienced menopause suffered from increased joint and spine pain. In comparison to other studies many few research papers are published in India on non-specific low back pain among post menopausal women. There is no study that combines the physiotherapy treatment exercises done conventionally and yoga asanas. Thus in order to improve the treatment outcomes and guide professionally, this study applies the combined treatment in post menopausal non specific low back pain women to check the effectiveness on pain and functional disability experienced at this stage. Need of the study Addressing the incidences of non specific low back pain experienced by post menopausal women. There quite number of studies on core stabilization intervention in non-specific low back pain in general population comprising of wide age range. But this study is being done specifically for a particular set of population that deals with the low back pain in their daily life. Though there are various studies present of Yoga being used as low back pain treatment in post menopausal involving long duration yoga session including the warm up time followed by yoga asanas and breathing. Thus the study emphasizes on both treatment and combines them considering both as equally important in treating the low back pain. Which focuses both on strength and flexibility of lumbar spine.
Aim This study aims to address the lack of research on combined use of core stabilization exercises and Yoga. It determine to explore the effectiveness of a program that will include both form of exercises. This study hope to provide solid evidence that can help the healthcare provider improve their treatment method. This research can lead to creation of new rehabilitation program that is both innovative and effective. Objectives 1. To test the efficacy of Physioyogic exercises for reduction of pain in postmenopausal women with non specific low back pain. 2. To test the efficacy of Physioyogic exercises for reduction in functional disability in postmenopausal women with non specific low back pain.
3. To compare the effectiveness of core stabilization and Physioyogic exercises in reduction of pain and functional disability in postmenopausal women with nonspecific low back pain. Hypothesis Null hypothesis 1.Physioyogic exercises have no significant effect on improvement in pain in post menopausal women. 2. Physioyogic exercises have no significant effect on reduction in functional disability in post menopausal women. Alternate hypothesis 1. Physioyogic exercises have significant effect on improvement in pain in post menopausal women. 2. Physioyogic exercises have significant effect on reduction in functional disability in post menopausal women.
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