Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284018
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-02-21
Brief Title:
Effect of Progressive Muscle Relaxation Exercises Versus Pilates Exercises on Postnatal Low Back Pain
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Effect of Progressive Muscle Relaxation Exercises Versus Pilates Exercises on Postnatal Low Back Pain
Status:
COMPLETED
Status Verified Date:
2024-06
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:
None
Brief Summary:
This study was conducted to compare between the effect of progressive muscle relaxation exercises and the effect of pilates exercises on postnatal low back pain
Detailed Description:
Ethical approval was obtained from the Institutional Review Board of the Faculty of Physical Therapy Cairo University before starting this study No PTREC012003885 The studys protocol was explained in detail to each woman who signed an informed consent form before starting this study This work adhered to the principles outlined in the Declaration of Helsinki for the ethical conduct of research involving human subjects It was carried out from June till September 2023
Sample Size Calculation
Based on a pilot study sample size was calculated according to the significant difference in the value of mean difference pretreatments - post treatment values of pain pressure algometer between progressive muscle relaxation exercises 201 039 and pilates exercises 290 024 groups in unpaired t test with α005 power of 80 and an effect size of 074 So a sample size of 30 patientsper group would be required and increased to 35 women to allow for a 15 dropout rate GPower 301 httpwwwpsychouni-duesseldorfde Randomization of sample selection was achieved using closed envelop way Classification of the sample by simple random way into two groups equal in number by using sixty closed envelop each thirty envelop contained a name of a group from the two groups Group A or Group B and asking each woman to choose one envelop from them each woman attended to the group according the name of the group written in her envelop After randomization they were divided into two groups equal in number
Sample Size Calculation
Based on a pilot study sample size was calculated according to the significant difference in the value of mean difference pretreatments - post treatment values of pain pressure algometer between progressive muscle relaxation exercises 201 039 and pilates exercises 290 024 groups in unpaired t test with α005 power of 80 and an effect size of 074 So a sample size of 30 patientsper group would be required and increased to 35 women to allow for a 15 dropout rate GPower 301 httpwwwpsychouni-duesseldorfde Randomization of sample selection was achieved using closed envelop way Classification of the sample by simple random way into two groups equal in number by using sixty closed envelop each thirty envelop contained a name of a group from the two groups Group A or Group B and asking each woman to choose one envelop from them each woman attended to the group according the name of the group written in her envelop After randomization they were divided into two groups equal in number
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