NCT06284018

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

February 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

February 21, 2024

Last Update Submit

June 27, 2024

Conditions

Keywords

Progressive muscle relaxation exercisesPilate's exercisesLow back pain.post natal periodrelaxation exercises

Outcome Measures

Primary Outcomes (1)

  • Pressure Algometer

    Assessment of pressure pain thresholds is a valid and reliable clinical tool to evaluate the subjective perception of pain in response to application of pressure in low back pain patient. Pressure algometry is used in manual therapy to objectively quantify the pressure pain thresholds and it was shown that a predictable variation exists across various spinal levels from cervical to lumbar levels. The examiner determined the main 4 points of assessment (5 cm lateral to the spinous process of L3 and L5 bilaterally), the force of PA was gradually increased at a rate of 1 kg/s, by silently counting seconds while increasing pressure, then the patient was asked to tell the examiner when the pressure became painful while the examiner applied the pressure on the assessment points

    period of treatment was 4 weeks

Secondary Outcomes (1)

  • Oswestry Disability Index

    period of treatment was 4 weeks

Study Arms (2)

intervention group1

EXPERIMENTAL

Group A consisted of thirty postnatal women. They were treated by progressive muscle relaxation exercises three times per week for 4 weeks.

Other: Progressive Muscle Relaxation Exercises

intervention group 2

EXPERIMENTAL

Group B consisted of thirty postnatal women. They were treated by pilates exercises three times per week for 4 weeks.

Other: Pilates Exercises

Interventions

* Focus on the targeted muscle group. * Take a slow, deep breath while squeezing on muscle group as hard as she can (not to the point of strain). Keep the muscle tensed for 5 seconds. Hands and arms, forehead ,Eyes and Cheek, Mouth and Jaw , Neck and Shoulder ,Stomach , Leg and Toes

intervention group1

Pilates exercise program consisted of floor exercises on a rubber mat, including the following exercises: a- Pelvic Curl. b- Single-Leg Lift. c- Chest Lift. d- Supine Spine Twist. e- Basic Back Extension.

intervention group 2

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy: Cairo university

Giza, 12662, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Hala M Emara, phd

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 21, 2024

First Posted

February 28, 2024

Study Start

February 24, 2024

Primary Completion

May 30, 2024

Study Completion

June 15, 2024

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations