NCT06387927

Brief Summary

Thirty male and female hypertension patients with chronic mechanical non-specific low back pain were included in this randomized controlled study conducted at the Ababa Private Physical Therapy Center in Beni-Seuf, Egypt. They were randomly assigned into two equal groups; the study group A control (n = 15) had a supervised conventional core stability, while the study group B (n = 15) received a home exercise program. In both groups' patients had evaluations before and after their six-week course of therapy. Modified-modified Schober test was used to assess the active back range of motion (ROM), Arabic version of Oswestry disability index (ODI) was utilized to evaluate functional disability, and visual analog scale (VAS) was used to measure pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

September 2, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

April 19, 2024

Last Update Submit

April 25, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assessment of pain

    Pain was assessed using the visual analog scale

    up to 4 weeks

  • Assessment of lumbar flexion range of motion

    performed by modified modified schober test

    up to 4 weeks

  • Assessment of functional disability

    performed by Oswestry disability questionnaire version 2.0

    up to 4 weeks

Study Arms (2)

Group A (control) received supervised conventional core stability exercise program Study

ACTIVE COMPARATOR

Group A (control) received supervised conventional core stability exercise program

Other: the core stability exercise

group B received a home-based exercise program

EXPERIMENTAL

Group B received a home-based exercise program.

Other: home exercise program

Interventions

Patients in group B were taught the core stability exercise in the first visit they received Arabic printed booklet for exercise description repetitions with diagrams in addition to Arabic illustration videos, they received a weekly telephone call to ensure their compliance to the exercise \& motivation.

group B received a home-based exercise program

supervised conventional core stability exercise

Group A (control) received supervised conventional core stability exercise program Study

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • hypertensive patient
  • patient with chronic back pain
  • The patients aged 30 to 50 years

You may not qualify if:

  • Patients with vertebral fractures
  • patient with surgical spinal fixation
  • patient with rheumatic disorders
  • patient with systemic diseases
  • patient with multiple sclerosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Giza, 3387722, Egypt

Location

MeSH Terms

Conditions

HypertensionLow Back Pain

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

April 19, 2024

First Posted

April 29, 2024

Study Start

September 2, 2023

Primary Completion

February 2, 2024

Study Completion

February 20, 2024

Last Updated

April 29, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations