NCT06427434

Brief Summary

This study will be carried out to evaluate the effect of modified lumbar Sustained Natural Apophyseal Glide on low back pain in postnatal women.

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 Jun 2024

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

May 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

May 19, 2024

Last Update Submit

May 26, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pain intenesity

    The visual analogue scale is a 10 cm calibrated line with 0 representing no pain and 10 representing the worst pain; will be used to assess the severity of pain before and after treatment for all participants in both groups.

    within 4 weeks

  • Lumbar flexion range of motion

    The modified Schober test will be used to measure the lumbar flexion range of motion (ROM) by using the tape measurement. Each participant will be asked to stand erect with her feet about shoulder-width apart to stabilize the pelvis. Then, the posterior superior iliac spines(PSIS) will be determined by the therapist's both thumbs, and then an ink line will be drawn along the midline of the lumbar spines horizontal to the PSIS to mark the midpoint between the two PSIS. Then tape will be used to identify and mark two points: one is 10 cm superior to the midpoint (A), and another is 5 cm inferior to the midpoint (B). The participant will be instructed to bend forward as much as she can while keeping both knees straight, the new distance between superior and inferior skin marking will be measured in centimeters. The increased distance along the tape due to lumbar flexion is normally about 6-7 cm (less than 5 cm should be considered abnormal).

    within 4 weeks

  • Lumbar extension range of motion

    The modified Schober test will be used to measure the lumbar extension range of motion (ROM) by using the tape measurement while the patient is in a standing position. The participant will be instructed to put her hands on her buttocks and bend backward into full lumbar extension and the new distance between the superior and inferior skin markings will be measured in centimeters by the tape measurement. The change in the difference between the marks is used to indicate the amount of lumbar extension. The increased distance along the tape due to the extension of the lumbar spine is normally about 2-3 cm (less than 1 cm should be considered abnormal).

    within 4 weeks

  • Lumbar lateral flexion range of motion

    The participant will be asked to stand erect with her feet about shoulder-width apart. Both right and left lateral flexion will be measured by the tape as the distance from the tip of the index finger to the floor at maximal comfortable lateral flexion. The participant will be instructed to bend her trunk laterally as much as she can. The normal value of lateral spinal flexion is 16.2-28.0 cm.

    within 4 weeks

Secondary Outcomes (1)

  • Functional disability

    within 4 weeks

Study Arms (2)

Strengthening and stretching exercises

ACTIVE COMPARATOR

The participants will be asked to perform strengthening and stretching exercises to the back and abdominal muscles for 30 min, three times per week for 4 weeks.

Other: Strengthening and stretching exercises to the back and abdominal muscles

Modified Lumbar Sustained Natural Apophyseal Glide

EXPERIMENTAL

The participants will receive Modified Sustained Natural Apophyseal Glide on the affected lumbar level for 30 sec three times per week for 4 weeks. In addition to strengthening and stretching exercises to the back and abdominal muscles for 30 min, three times per week for 4 weeks

Other: Strengthening and stretching exercises to the back and abdominal musclesOther: Modified Lumbar Sustained Natural Apophyseal Glide

Interventions

Strengthening and stretching exercises to the back and abdominal muscles will be performed for 30 min, three times per week for 4 weeks.

Modified Lumbar Sustained Natural Apophyseal GlideStrengthening and stretching exercises

Modified Sustained Natural Apophyseal Glide will be applied on the affected lumbar level for 30 sec three times per week for 4 weeks.

Modified Lumbar Sustained Natural Apophyseal Glide

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All participants will be diagnosed as chronic postnatal low back pain.
  • Their ages will be ranged from 20 to 35 years old.
  • Their body mass index (BMI) will not exceed 30 kg/m2.
  • All participants have the same social level.
  • All participants have the same lifestyle.
  • Their number of parity will be ranged from 2-4 children.

You may not qualify if:

  • Spinal fracture or any other neurological disorders.
  • Lumbar spinal stenosis from lumbar disc herniation, degenerative joint diseases, or spondylolisthesis.
  • Women with BMI \> 30 kg/m2.
  • Participants who had pelvic pathology.
  • Skin disease interferes with mobilization application.
  • Gynecological diseases (chronic pelvic pain, uterine prolapse and retroversion flexion of the uterus).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mina Nageb Soliman

Cairo, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Azza Kassab, professor

    Cairo University

    STUDY DIRECTOR

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

May 19, 2024

First Posted

May 23, 2024

Study Start

June 1, 2024

Primary Completion

December 15, 2024

Study Completion

December 30, 2024

Last Updated

May 30, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations