NCT04942782

Brief Summary

the purpose of this trial is to investigate and compare between lumbopelvic stabilization and pilates exercises on gait cycle phases and maximum peak pressure on the foot in chronic nonspecific low back pain?

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable low-back-pain

Status
unknown

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

June 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

June 28, 2021

Status Verified

June 1, 2021

Enrollment Period

1 month

First QC Date

June 24, 2021

Last Update Submit

June 24, 2021

Conditions

Keywords

lumbopelvaic stabilization exercisepilates exercisegait cycle phasespeak pressure

Outcome Measures

Primary Outcomes (1)

  • gait cycle phases and maximum peak pressure on foot

    gait cycle phases and peak pressure will be measure by Tekscan walkway

    up to twelve weeks

Secondary Outcomes (3)

  • pain intensity

    up to twelve weeks

  • disability

    up to twelve weeks

  • muscle endurance

    up to twelve weeks

Study Arms (3)

lumbopelvic stabilization exercises

EXPERIMENTAL

the patients will receive trunk stabilization exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months

Other: lumbopelvic stabilization exercisesOther: conventional therapy

Pilates exercises

EXPERIMENTAL

the patients will receive trunk pilates exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months

Other: pilates exerciseOther: conventional therapy

conventional therapy

ACTIVE COMPARATOR

the patients will receive trunk stabilization exercise three times/ week for three months

Other: conventional therapy

Interventions

the patients will receive lumbopelvic stabilization in the form of three parts: 1 Segmental control over primary stabilizers (mainly TrA, deep multifidus, pelvic floor and diaphragm) 2-Exercises in closed chain, with low velocity and low load 3-Exercises in open chain, with high velocity and load

lumbopelvic stabilization exercises

the patient will receive pilates exercise in the form of Breast stroke prep, Side leg lift series, One leg circle, Hundreds, Shoulder bridge, and Spine stretch forward

Pilates exercises

Patients will received strengthening exercises for the abdominal, back, and hip muscles. The patients performed an average of three series of ten repetitions of each exercise. Increases in the number of exercises performed in each session (or load progression) occurred according to individual tolerance

Pilates exercisesconventional therapylumbopelvic stabilization exercises

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Their age between 20 and 40 years
  • patients is required to have chronic nonspecific LBP (more than12 weeks), defined as Pain in the lumbar and/or buttock region (defined as pain reported below the level of T12 and no lower than the buttock line).
  • Patients will be excluded if they have signs of serious spinal pathology (red flags) including significant trauma, unexplained weight loss, and widespread neurologic changes

You may not qualify if:

  • subjects with specific back pain (fracture, osteoporosis or degenerative changes, prolapse intervertebral disc, bone disorders, arthritis, tumour),
  • subjects with neurological involvement (radiculopathy, myelopathy),
  • subjects with previous spinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Central Study Contacts

al shaymaa sh abd el azeim, lecturer

CONTACT

al shaymaa sh abd el azeim, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
random generator
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: lumbopelvic stabilization and Pilates
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

June 24, 2021

First Posted

June 28, 2021

Study Start

July 1, 2021

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

June 28, 2021

Record last verified: 2021-06