NCT06398249

Brief Summary

The primary purpose of this study is to investigate the effects of deep breathing pattern on dynamic balance in patients with chronic mechanical low back pain versus healthy controls. Secondary to compare between dynamic balance control during deep versus regular breathing patterns in patients with chronic mechanical low back pain and healthy controls. Further, to detect whether pain intensity differs during balance testing applying either deep or regular breathing in patients with chronic mechanical low back 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 all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

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

February 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

April 16, 2024

Last Update Submit

October 10, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • dynamic balance testing -

    overall, mediolateral( ML), and anteroposterior(AP).

    At subject enrollment "single session"

  • pain intensity

    visual analogue scale. A 10 cm horizontal line with one end denote "no pain" and the other end denote "severe intractable pain

    At subject enrollment "single session"

Study Arms (2)

Experimental

chronic mechanical low back pain

control

healthy matched controls

Eligibility Criteria

Age20 Years - 40 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsTheir age will range between 20 and 40 years,
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Chronic low back pain patients from referrals to out patients clinics at faculty of physical therapy Cairo university. Matched healthy volunteers from students and employees of faculty of physical therapy Cairo university

You may qualify if:

  • Participants in both groups should fulfill the criteria set for age and BMI ranges.
  • Patients in study group should complain of pain in the lower back for a period of more than 3 months.
  • Referred from an orthopedist .
  • Participants in control group should haven't complained of back pain

You may not qualify if:

  • Patients complain of radiculopathy .
  • Patients complain of any other musculoskeletal disorder other than chronic mechanical low back pain .
  • Any previous or current complains of pain involving other regions of the spine.
  • Have history of respiratory dysfunction due to current or previous respiratory condition.
  • suffer from any condition that affect balance control, including neurological, vestibular, visual or somatosensory deficits.
  • use drugs that might compromise their balance control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Sadat, Menofia, 32897, Egypt

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 16, 2024

First Posted

May 3, 2024

Study Start

February 2, 2024

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations