Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04721639
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2021-01-20
Brief Title:
To Observe the Effect of Sphinx Pose Salamba Bhujangasana Among Health Care Providers With Chronic Low Back Pain
Sponsor:
University of Karachi
Organization:
University of Karachi
Study Overview
Official Title:
Effect of Sphinx Pose Salamba Bhujangasana Among Health Care Providers With Chronic Low Back Pain A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLBP
Brief Summary:
This Randomized Controlled trial is designed to observe the effect of Sphinx Yoga Salamba Bhujangasana on low back pain and variation in the associated physiological parameters that help explain the beneficial effects of yoga among healthcare providers of Karachi Pakistan Healthcare providers with LBP determined as per the baseline assessment will be recruited and Substance P and Beta Endorphins will be assessed at baseline and after 3 months The subjects with LBP will be determined based on the scores of the Oswestry Low Back Pain Disability Questionnaire Numerical Pain Rating NPR scale Roland Morris Disability Questionnaire RMDQ and Fear Avoidance Beliefs Questionnaire FABQ work subscale Subjects meeting eligibility criteria will be randomly allotted to intervention and control groups The study outcomes will be monitored in subjects of both groups at baseline and after 3-month follow-up post-interventional
Detailed Description:
Plan of work
Assessment of eligibility Enrollment HCPs experiencing LBP as per the eligibility criteria will be enrolled
Baseline Assessment All the variables ie Oswestry Low Back Pain Disability Questionnaire World Health Organization Quality of Life WHOQOL Roland Morris Disability Questionnaire RMDQ and Sadaf Stress Scale SSS Substance-P and Beta Endorphins will be measured at baseline
Randomization Allocation Eligible consenting subjects will be randomly allocated to the experimental or control group
Follow-up Assessment All the outcome measures observed at baseline will be re-assessed after 3 months
Statistical Analysis Pre post-analysis will be conducted
Study design The study will be conducted as a Randomized Controlled trial at a primary healthcare setting The participant eligibility will be assessed using a pre-screening questionnaire including components of disability questionnaires Based on the eligibility criteria consenting HCPs will be recruited and randomized into two groups ie Group A experimental including participants who will receive the intervention and Group B control receiving no intervention The study outcomes will be monitored among participants of both groups at baseline and post-intervention 3-month follow-up
Participants Healthcare providers with LBP will be recruited with no restriction for ethnicity or race The participants from diverse socio-cultural backgrounds will be considered eligible if they meet the inclusion criteria The study objective will be explained and participants will be invited to participate based on their free-will
Sampling Size The required sample size for the two study groups with α 005 and 1- α 080 was estimated to be 49 in each group ie the total sample size was 98 for two groups The sample size calculator provided by the UCSF CTSI was used
Randomization After assessing the eligibility the participants will be randomly allocated in the ratio of 11 to the study groups experimental and control The randomization sequence will be computer-generated After acquiring the basic information a unique code will be assigned to each of the study participants which will then be mentioned in their Performa
Interventions The experimental intervention The Group A participants will be intervened with Sphinx Yoga therapy which will take place in a conserved therapy center of Koohi Goth Hospital This stretching exercise session will take place in the afternoon and for a duration of 10 minutes followed by 30 minutes therapy session five times per week total 12 weeks
The control intervention Group B participants wont be receiving any intervention and provided with the usual care
Assessment of eligibility Enrollment HCPs experiencing LBP as per the eligibility criteria will be enrolled
Baseline Assessment All the variables ie Oswestry Low Back Pain Disability Questionnaire World Health Organization Quality of Life WHOQOL Roland Morris Disability Questionnaire RMDQ and Sadaf Stress Scale SSS Substance-P and Beta Endorphins will be measured at baseline
Randomization Allocation Eligible consenting subjects will be randomly allocated to the experimental or control group
Follow-up Assessment All the outcome measures observed at baseline will be re-assessed after 3 months
Statistical Analysis Pre post-analysis will be conducted
Study design The study will be conducted as a Randomized Controlled trial at a primary healthcare setting The participant eligibility will be assessed using a pre-screening questionnaire including components of disability questionnaires Based on the eligibility criteria consenting HCPs will be recruited and randomized into two groups ie Group A experimental including participants who will receive the intervention and Group B control receiving no intervention The study outcomes will be monitored among participants of both groups at baseline and post-intervention 3-month follow-up
Participants Healthcare providers with LBP will be recruited with no restriction for ethnicity or race The participants from diverse socio-cultural backgrounds will be considered eligible if they meet the inclusion criteria The study objective will be explained and participants will be invited to participate based on their free-will
Sampling Size The required sample size for the two study groups with α 005 and 1- α 080 was estimated to be 49 in each group ie the total sample size was 98 for two groups The sample size calculator provided by the UCSF CTSI was used
Randomization After assessing the eligibility the participants will be randomly allocated in the ratio of 11 to the study groups experimental and control The randomization sequence will be computer-generated After acquiring the basic information a unique code will be assigned to each of the study participants which will then be mentioned in their Performa
Interventions The experimental intervention The Group A participants will be intervened with Sphinx Yoga therapy which will take place in a conserved therapy center of Koohi Goth Hospital This stretching exercise session will take place in the afternoon and for a duration of 10 minutes followed by 30 minutes therapy session five times per week total 12 weeks
The control intervention Group B participants wont be receiving any intervention and provided with the usual care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None