NCT07163117

Brief Summary

Low Back Pain (LBP) as estimates show that up to 84% of adults will experience LBP at some point in their lifetime, ranking it as a leading cause of disability globally. If the pain lasts more than 12 weeks and remains difficult to manage effectively, it can be called Chronic low back pain (CLBP). Physical therapy interventions play an important role in the non-pharmacological management of CLBP including lumbar stabilization exercises (LSEs) and back extension/endurance exercises which are commonly prescribed modalities that may help in improving the spinal function, reducing pain and improving the quality of life in general.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

September 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 9, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

September 1, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

stabilization exercisesrange of motionendurance traininglumber spine

Outcome Measures

Primary Outcomes (1)

  • Spinal range of motion (ROM)

    Two inclinometers will be used. One placed at T12-L1 (thoracic 12- lumbar 1) and another placed at L5-S1 (lumbar 5-sacrum 1), respectively.

    4 weeks

Secondary Outcomes (1)

  • Trunk Endurance

    4 weeks

Study Arms (3)

Group A (Lumbar stabilization group)

EXPERIMENTAL

This group will receive lumbar stabilization exercises in addition to home based program two times per week for four consecutive weeks.

Other: lumbar stabilization exercisesOther: Home based program

Group B (Trunk endurance)

EXPERIMENTAL

This group will receive trunk endurance exercises for back flexors and extensors in addition to home based program two times per week for four consecutive weeks.

Other: endurance trainingOther: Home based program

Group C (control group)

ACTIVE COMPARATOR

This group will receive home based program two times per week for four consecutive weeks.

Other: Home based program

Interventions

The participants required to be in a prone position with pillow under abdomen, first raise one leg then the other leg, raise one arm then the other arm, after that raise two legs together, then raise two arms together, raise right arm with left leg then left arm with right leg, then raise both arms and both legs together, every position hold for 20 seconds. Then they required to be in a half kneeling on standing for right leg hold for 20 second and repeat for other leg, do it again but their knees doesn't touch the ground. Finally they required to lie on their backs, and bend their knees at around a 90 degree angle. Place their hands to their sides and their feet flat on the floor at about shoulder width and asked to raise their hips off the floor, hold 20 second.

Group A (Lumbar stabilization group)

1. Back extensor endurance training exercise: The participants lay prone over the end of a treatment table with the anterior superior iliac spine supported on the bench edge. Their ankles were fixed by the researcher. They maintained the horizontal position for as long as possible, beginning timing when the horizontal unsupported position was achieved and ending when they dropped below the horizontal plane. The duration of holding was measured in seconds. 2. Back flexor endurance training exercise: The participants asked to sit on the table with your arms crossed against their chest and their back against the wedge. Fix them to the table with a belt across the feet. They asked to remove the wedge from their back using the timing device to record how much time is accumulated until the original position can no longer be maintained.

Group B (Trunk endurance)

General and similar exercises for back muscles introduced for this group. They instructed to do knee to chest stretch, lower back rotational stretch, bridge exercise. The required measure data were obtained from the selected cases in this group before and after the end of rehabilitation program.

Group A (Lumbar stabilization group)Group B (Trunk endurance)Group C (control group)

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI ranged from 28 to 29 kg/ cm2.
  • clinically diagnosed by an orthopedic consultant as having a history of mechanical low back pain for at least three months.

You may not qualify if:

  • Previous trauma.
  • Previous surgery.
  • Any musculoskeletal disorder
  • Any neurological disorder (disc prolapse, or spondylosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Endurance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Nesma M Allam, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Study Record Dates

First Submitted

September 1, 2025

First Posted

September 9, 2025

Study Start

September 9, 2025

Primary Completion

December 15, 2025

Study Completion

January 15, 2026

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication

Locations