NCT06009263

Brief Summary

To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on pain intensity, lumbar ROM, and CSA of multifidus muscle.

Trial Health

57
Monitor

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 2023

Typical duration 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

August 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

September 2, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

April 3, 2025

Status Verified

September 1, 2024

Enrollment Period

1.9 years

First QC Date

August 13, 2023

Last Update Submit

April 1, 2025

Conditions

Mechanical Low Back Pain

Keywords

Mechanical LBPCross Sectional AreaMultifidus muscle

Outcome Measures

Primary Outcomes (2)

  • Cross sectional area of multifidus muscle

    Cross sectional area of multifidus muscle

    Pre and Post measurement (12 weeks)

  • Pain intensity

    Measured by VAS (from 0 to 10; 0 means no pain and 10 means worst pain)

    Pre and Post measurement (12 weeks)

Secondary Outcomes (2)

  • ROM of lumbar spine

    Pre and Post measurement (12 weeks)

  • Functional ability of lumbar spine

    Pre and Post measurement (12 weeks)

Study Arms (3)

Control

SHAM COMPARATOR

The participants will receive conventional treatment in the form of TENS and Ultrasound.

Other: Conventional treatment

Intervention 1

EXPERIMENTAL

The participants will receive "open chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound.

Other: Open chain segmental control

Intervention 2

EXPERIMENTAL

The participants will receive "closed chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound.

Other: Closed chain segmental control

Interventions

Conventional treatmentOTHER

Application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.

Control
Open chain segmental controlOTHER

Application of "open chain segmental control exercises" As well as, application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.

Intervention 1
Closed chain segmental controlOTHER

Application of "closed chain segmental control exercises" As well as, application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.

Intervention 2

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with chronic low back pain from both genders their age will be ranged and divided into three groups from 25-55 years.
  • Participants with chronic low back pain lasting for more than 6 Months.
  • A patient who can follow the command.
  • A patient who can do exercise.

You may not qualify if:

  • Low back pain patients with a history of severe neurological disease or orthopedic disease.
  • History of Psychological Disorder.
  • Unhealthy Patient.
  • Pregnant women.
  • Patient with a spinal tumor.
  • History of any operation related to spine. Ex. Vertebral fracture or dislocation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, Dokki, 12612, Egypt

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Haytham M Elhafez, PhD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haytham M Elhafez, PhD

CONTACT

+201001909630elhafez@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Group will receive open chain segmental control exercises versus closed chain segmental control exercises
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group will receive ultrasound and TENS as conventional treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 13, 2023

First Posted

August 24, 2023

Study Start

September 2, 2023

Primary Completion

August 13, 2025

Study Completion

September 1, 2025

Last Updated

April 3, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)