NCT03121703

Brief Summary

Purpose: The purpose of this study is to investigate the effects of lumbar stabilization exercises on pain intensity, transversus abdominis muscle (TrA) activation capacity, functional disability, and TrA thickness in patients with chronic low back pain (CLBP). Subjects: The subjects of this study were 30 CLBP patients. Methods: The experimental group performed diverse lumbar stabilization exercises in different postures, and the control group conducted an ordinary trunk muscle strengthening exercise. Results: There were significant differences in pain intensity, TrA activation capacity, functional disability, and TrA thickness between before and after the intervention in both groups. Significant differences between the two groups were shown in the pain intensity, TrA activation capacity, and functional disability after the intervention. However, there were no significant differences between the two groups in TrA thickness. Conclusion: Lumbar stabilization exercises in different postures could reduce pain, functional disability, and increase TrA activation capacity and thickness in CLBP patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable low-back-pain

Status
unknown

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

April 12, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

29 days

First QC Date

April 12, 2017

Last Update Submit

April 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • transverse abdominis thickness

    ultrasound image for measuring transverse abdominis thickness

    1 year

Study Arms (2)

lumbar stabilization exercises group

EXPERIMENTAL

diverse lumbar stabilization exercises

Other: lumbar stabilization exercise

trunk muscle strengthening exercise

OTHER

trunk muscle strengthening exercise

Other: trunk muscle strengthening exercise

Interventions

lumbar stabilization exercise

lumbar stabilization exercises group

trunk muscle strengthening exercise

trunk muscle strengthening exercise

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients who felt low back pain

You may not qualify if:

  • Orthopedic surgery within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 20, 2017

Study Start

May 1, 2017

Primary Completion

May 30, 2017

Study Completion

June 30, 2017

Last Updated

April 20, 2017

Record last verified: 2017-04