NCT06990113

Brief Summary

to investigate The Efficacy of three-dimensional lumbar myofascial release with motor control training on back perception and pain in lumbar radiculopathy Patients with lumbar radiculopathy demonstrate impairments in function and range of motion to deficits in patient's quality of life.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 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

Study Start

First participant enrolled

April 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

May 18, 2025

Last Update Submit

May 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Fremantle Back Awareness Questionnaire

    The Fremantle Back Awareness Questionnaire (FreBAQ) has been found to possess adequate psychometric properties in low back pain (LBP) patients worldwide

    four weeks

  • Oswestry Low Back Pain Disability Questionnaire

    The Oswestry Disability Index (ODI) a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain

    four weeks

Secondary Outcomes (2)

  • pressure pain algometer

    four weeks

  • visual analog scale

    four weeks

Study Arms (2)

study group

EXPERIMENTAL

received three dimensional lumbar myofascial release with motor control training, and conventional treatment

Other: three dimensional lumbar myofascial releaseOther: conventional treatment.

control group

EXPERIMENTAL

received conventional physical therapy modalities, including electrotherapy and flexibility treatment

Other: conventional treatment.

Interventions

Three-dimensional (3D) MFR is a novel approach toward reducing fascial restrictions. It recognizes that fascia exists not only in a linear plane but also in complex multidirectional networks throughout the body.

Also known as: (3D) MFR
study group

conventional treatment, including selected physical therapy, flexibility exercise for the back, static back and abdomen exercises, and electrotherapy

control groupstudy group

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Their ages range from 35 to 50 years.
  • Both sex
  • Unilateral lumbar radiculopathy for more than 6 months.
  • Normal body mass index (18.5 - 24.99Kg/m2).

You may not qualify if:

  • Any other musculoskeletal disorders of the spine or upper extremity
  • Patients with any other Neurological deficits, psychiatric disease lumbar myelopathy, Cognitive problems, vertebral fractures and previous history of spine or lumbar surgery.
  • Clinical instability, recent trauma
  • Structural abnormalities of the spine, osteoporosis, and spasmodic torticollis.
  • Inflammatory or other specific disorders of spina such as ankylosing spondylitis and rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lama Saad El-Din Mahmoud

Al Jīzah, Select State, 0020, Egypt

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Lama Saad El-Din ED Mahmoud

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patients were randomly divided into two equal groups; Study group (16 patients): received three dimensional lumbar myofascial release with motor control training, and conventional treatment. Control group (16 patients): received conventional treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology and Neurosurgery Faculty of Physical Therapy October 6 University

Study Record Dates

First Submitted

May 18, 2025

First Posted

May 25, 2025

Study Start

April 15, 2025

Primary Completion

June 30, 2025

Study Completion

July 15, 2025

Last Updated

May 25, 2025

Record last verified: 2025-05

Locations