NCT05047614

Brief Summary

This study is conducted to answer the following question: What is the effect of lumbar repositioning feedback and transverses abdominis training on lumbar proprioception in patients with chronic mechanical low back pain?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

July 22, 2020

Last Update Submit

September 13, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pressure biofeedback unit

    Assessment of transversus abdominis activation

    up to 45 days

  • feedback laser tracker

    Assessment of lumbar repositioning error

    up to 45 days

Study Arms (4)

Study 1

EXPERIMENTAL

Twelve patients in study group 1 receiving lumbar repositioning feedback training

Device: including sham

Study 2

EXPERIMENTAL

Twelve patients in study group 2 receiving transverses abdominis training

Device: including sham

Study 3

EXPERIMENTAL

Twelve patients in study group 3 receiving both lumbar repositioning feedback training and tranversus abdominis training

Device: including sham

Control

EXPERIMENTAL

Twelve patients in control group receiving conventional lumbar propriception physical therapy program .

Device: including sham

Interventions

Repositiong feedback training and biofeedback pressure training unit

ControlStudy 1Study 2Study 3

Eligibility Criteria

Age35 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with CMLBP referred from orthopedic surgeon with no radicular pain
  • Their age is ranged between 35-55 years old (Martim etal.,2008)
  • BMI 24-28 kg/m2

You may not qualify if:

  • Patients who have a history of diabetic peripheral neuropathies
  • Patients who have a history of sciatica
  • Spinal or lower limb deformity or any pathology within the spine.
  • Patients who have neurological disorders
  • Patients who have a history of previous lumbar surgery
  • Patients who have visual problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 university

Giza, 12511, Egypt

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Central Study Contacts

MAI HASSAN, Doctoral

CONTACT

Hossam Magdy, Doctoral

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

July 22, 2020

First Posted

September 17, 2021

Study Start

April 19, 2020

Primary Completion

May 2, 2022

Study Completion

August 15, 2022

Last Updated

September 17, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations