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Effect of Progressive Muscle Relaxation Exercises Versus Pilates Exercises on Postnatal Low Back Pain

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Low Back Pain

Treatments

Other: Pilates Exercises
Other: Progressive Muscle Relaxation Exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT06284018
postnatal low back pain

Details and patient eligibility

About

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

Full description

Ethical approval was obtained from the Institutional Review Board of the Faculty of Physical Therapy, Cairo University, before starting this study [No: P.T.REC/012/003885]. The study's 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 (2.01 ± 0.39) and pilates exercises (2.90 ± 0.24) groups in unpaired t test, with α=0.05, power of 80%, and an effect size of 0.74. So a sample size of 30 patients/per group would be required and increased to 35 women to allow for a 15% dropout rate (GPower 301 http:www.psycho.uni-duesseldorf.de) 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

Enrollment

60 patients

Sex

Female

Ages

25 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ages were ranged from 25 to 35 years old and their body mass index (BMI) did not exceed 30kg/m2. They were postnatal by three months. The number of parity of all women was ranged from (1-3) times.

Exclusion criteria

  • previous trauma to the spine, pelvis and lower limbs,
  • previous history of spinal surgery (such as spinal fusion surgery, vertebroplasty, or - --kyphoplasty), congenital spinal deformities, history of spinal tumors, ankylosing spondylitis, osteoporosis other spondyloarthritis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

intervention group1
Experimental group
Description:
Group A consisted of thirty postnatal women. They were treated by progressive muscle relaxation exercises three times per week for 4 weeks.
Treatment:
Other: Progressive Muscle Relaxation Exercises
intervention group 2
Experimental group
Description:
Group B consisted of thirty postnatal women. They were treated by pilates exercises three times per week for 4 weeks.
Treatment:
Other: Pilates Exercises

Trial contacts and locations

1

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Central trial contact

Nourhan A Safy Eldeen Mahmood, phd

Data sourced from clinicaltrials.gov

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