NCT06558383

Brief Summary

The current study aims to determine the impact of augmented posterior oblique sling activation on lumbopelvic recruitment pattern and functional outcomes in patients with unilateral lumbosacral radiculopathy.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

June 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

August 14, 2024

Last Update Submit

August 27, 2024

Conditions

Keywords

posterior oblique slingrecruitment patternlumbar radiculopathy

Outcome Measures

Primary Outcomes (2)

  • surface EMG unit

    The electromyographic pattern of activation of lumbopelvic musculature (sequence and level of activity) will be measured during prone hip extension testing using surface EMG unit.

    measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

  • Pressure biofeedback unit

    it will be used to assess pelvic motion. the pressure sensor of the pressure biofeedback unit will be placed anteriorly between the patients' ilium and the testing table. The amount of pressure applied by the patient on the sensor at rest will be recorded then, the amount of pressure applied by patients at prone hip extension at 10 degrees will be recorded.

    measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

Secondary Outcomes (3)

  • pressure algometry

    measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

  • Arabic version of Oswestry Low Back Pain Disability Questionnaire

    measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

  • back pain intensity using the Visual analogue scale

    measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention

Study Arms (2)

control group -

ACTIVE COMPARATOR

Control group (A): Twenty patients will receive selected physical therapy program for 18 sessions, three sessions per week for six weeks in form hot packs, soft tissue techniques, mobilization and manipulation of lumbar spine, and neurodynamics.

Other: selected physical therapy program

study group

ACTIVE COMPARATOR

Study group (B): Twenty patients will receive augmented activation of posterior oblique sling in addition to selected physical therapy program, 18 sessions, three sessions per week for six week

Other: augmented posterior oblique sling activationOther: selected physical therapy program

Interventions

activation of posterior oblique sling for 18 sessions, three sessions per week for six weeks

study group

selected physical therapy program for 18 sessions, three sessions per week for six weeks in form hot packs, soft tissue techniques, mobilization and manipulation of lumbar spine, and neurodynamics and stabilization exercises

control group -study group

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ranges from 25 to 40
  • L4/5 and L5/S1 disc herniation.
  • Duration of pain will be more than three months.
  • Normal body mass index (18.5 - 24.99Kg/m2)

You may not qualify if:

  • \. Red flags: spinal tumors, cauda equina syndrome, spinal fractures, osteoporosis, infection.
  • \. Bilateral symptoms. 3. Spondylolisthesis, spondylitis, and spinal canal stenosis. 4. Previous lumbopelvic or hip surgery or injection 5. Any hip structural abnormality such as malformations, impingements and degeneration.
  • \. Postural deviations such as scoliosis, kyphosis, lateral shift. 7. True leg length discrepancy. 8. Pregnancy and Gynecological problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy Cairo university

Giza, Egypt

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Hoda M Zakaria, professor

    Cairo University

    STUDY CHAIR
  • Ebtesam M Fahmy, professor

    Cairo University

    STUDY CHAIR
  • Nagwa M Ibrahim

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial. True experimental research design study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of physical therapy for neurology and neurosurgery

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 16, 2024

Study Start

June 1, 2024

Primary Completion

December 1, 2024

Study Completion

February 1, 2025

Last Updated

August 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations