Clinical trial NCT06284018: Effect of Progressive Muscle Relaxation Exercises Versus Pilates Exercises on Postnatal Low Back Pain
Official title: Effect of Progressive Muscle Relaxation Exercises Versus Pilates Exercises on Postnatal Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Progressive muscle relaxation exercises
Pilate's exercises
Low back pain.
post natal period
relaxation exercises
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention The design of the study was randomized controlled study. The patients were divided randomly into two equal groups (A\&B). Group A consisted of thirty postnatal women. They were treated by progressive muscle relaxation exercises three times per week for 4 weeks. Group B consisted of thirty postnatal women. They were treated by pilates exercises three times per week for 4 weeks.
Primary purpose: TREATMENT

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 \[No: P.T.REC/012/003885\]. 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

Eligibility criteria: 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

Primary outcomes:
measure: Pressure Algometer
timeFrame: period of treatment was 4 weeks
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: period of treatment was 4 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of physical therapy: Cairo university
Study officials:
affiliation: Cairo University
name: Hala M Emara, phd
role: STUDY_DIRECTOR
References: