NCT06600074

Brief Summary

This study will be conducted to determine the effect of retro walking on post partum low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

September 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

September 12, 2024

Last Update Submit

December 19, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual analog scale (VAS)

    It will be used to measure the severity of post cesarean low back pain before and after the treatment program for all participants in both groups. The VAS is ten cm horizontal line on which the patients' pain intensity is represented by a point between the extremes of no pain at all (no pain=0) and worst pain imaginable (worst pain=10). Each participating woman will be asked to put a mark on the line at the point indicating her pain level / intensity.

    6 weeks

  • Lumbar flexion range of motion (ROM)

    It will be assessed by the Modified Schober test before and after the treatment program for all participants in both groups. The therapist will mark the lumbar spine at the posterior superior iliac spines, with another mark 15 cm above it. A tape measure will be used to record the distance between the marks in a standing position, then again after the patient bends forward into full lumbar flexion. The difference indicates the lumbar flexion ROM. This test will be repeated three times, and the average value will be taken as the lumbar flexion ROM.

    6 weeks

  • Lumbar extension range of motion (ROM)

    It will be assessed by the Modified Schober test before and after the treatment program for all participants in both groups. The therapist will mark the lumbar spine at the posterior superior iliac spines, then place another mark 15 cm above. A tape measure will record the distance between the marks while the patient is standing. The patient will then bend backward into full lumbar extension, and the new distance between the marks will be measured. The difference represents the lumbar extension ROM. This process will be repeated three times, with the average value taken as the lumbar extension ROM.

    6 weeks

Secondary Outcomes (1)

  • Oswestry disability questionnaire

    6 weeks

Study Arms (2)

Back care advice + Postural correction exercises

ACTIVE COMPARATOR

It will include 18 postpartum women who will receive back care advice and postural correction exercises.

Behavioral: Back care adviceOther: Postural correction exercises

Back care advice + Postural correction exercises + Retro-walking

EXPERIMENTAL

It will include 18 postpartum women who will receive the same back care advice and postural correction exercises, in addition to retro-walking.

Behavioral: Back care adviceOther: Postural correction exercisesOther: Retro-walking

Interventions

All patients in both groups will be advised to use proper lifting techniques, avoid prolonged sitting or standing, maintain a healthy weight, quit smoking, practice good posture, take breaks, spread housekeeping duties over the whole week, and sleep in supportive positions.

Back care advice + Postural correction exercisesBack care advice + Postural correction exercises + Retro-walking

All patients in both groups will be instructed to perform postural correction exercise. They will be performed from different positions (crock lying, supine lying, supine, sitting and standing position). They will lie in crock lying position for example and the physical therapist will instruct them to do chin in , open out ribs through costal breathing, contract abdominal muscles, contract glutei, hold for 6 seconds and relax and repeat 10 times.

Back care advice + Postural correction exercisesBack care advice + Postural correction exercises + Retro-walking

Patients in the experimental group only will practice walking backward on a treadmill, starting with a 5-minute warm-up at a self-selected speed, then gradually increasing speed from 1.2 to 1.6 m/s based on comfort and progress.

Back care advice + Postural correction exercises + Retro-walking

Eligibility Criteria

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

You may qualify if:

  • Multi parous women suffering from postpartum low back pain after cesarean delivery (from 6 weeks to 6 months after delivery).
  • Their ages will range from 25-35 years old.
  • Their body mass index will be less than 30 Kg/m2.
  • They should have mild to moderate low back pain as scored on VAS (represented by cut points on the scale recommending mild pain (5- 44mm), moderate pain (45- 74mm))

You may not qualify if:

  • Recent surgeries, trauma or fractures of the lower limb or in the back region.
  • Morbid cardiovascular disease.
  • Liver or kidney dysfunction.
  • Any neurological disorders including balance issues or motor and sensory loss.
  • Any musculoskeletal disorders such as disc prolapsed, lumbar canal stenosis and spondylysthesis or severe knee osteoarthritis.
  • Taking intra-articular injection for knee for the last 6 months.
  • Those having visual dysfunction or refractory errors not corrected with glasses or contact lenses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Puerperal DisordersLow Back Pain

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Afaf Mohamed Mahmoud Botla, PhD

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2024

First Posted

September 19, 2024

Study Start

September 16, 2024

Primary Completion

November 22, 2024

Study Completion

December 1, 2024

Last Updated

December 20, 2024

Record last verified: 2024-12

Locations