NCT04554563

Brief Summary

Non-specific low back pain is the most cause of adult disability throughout life. Its prevalence widens in young adults. Background of this pathology can be multifactorial. One of the most common is poor core stability and overloading of the local tissues as a result. Among treatment methods stabilizing training is commonly used with good effects. This form of therapy affects the transverse abdomen and multifidus muscles. To assess these structures several methods can be applied, e.g. sonofeedback. Our hypothesis claims that the core muscles morphology will change over the training process duration, in result, the analgesic effect will be achieved.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2021

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

September 12, 2020

Last Update Submit

January 8, 2021

Conditions

Keywords

low back painultrasoundsonofeedbackcore stabilitylumbar spinetransverse abdomenmultifidus

Outcome Measures

Primary Outcomes (3)

  • Ultrasound

    Non-invasive measure of the TrA and MF muscles

    5 minutes

  • Pain level

    Numeric Rating Scale. Picking the number on a scale from 0 to 10.

    1 minute

  • Questionnaire

    Oswestry Disability Index questionnaire - subjective disability measure throughout daily living activities.

    5 minutes

Study Arms (2)

Training group

EXPERIMENTAL

4-week core stability training

Other: Core stability training

Control group

NO INTERVENTION

Standard physical therapy

Interventions

20 sessions of specific core stability exercise with no external loading.

Training group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • low back pain
  • age from 18 to 30 years old
  • written consent of the participants

You may not qualify if:

  • injuries of the spine
  • fractures of the spine
  • surgery interventions in the spine region prior to the study
  • psychiatric disorders
  • neurologic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinika Fizjoterapii

Wroclaw, Lower Silesian Voivodeship, 50-234, Poland

Location

Related Publications (3)

  • Masse-Alarie H, Beaulieu LD, Preuss R, Schneider C. Repetitive peripheral magnetic neurostimulation of multifidus muscles combined with motor training influences spine motor control and chronic low back pain. Clin Neurophysiol. 2017 Mar;128(3):442-453. doi: 10.1016/j.clinph.2016.12.020. Epub 2016 Dec 28.

    PMID: 28160750BACKGROUND
  • Hides JA, Walsh JC, Smith MMF, Mendis MD. Self-Managed Exercises, Fitness and Strength Training, and Multifidus Muscle Size in Elite Footballers. J Athl Train. 2017 Jul;52(7):649-655. doi: 10.4085/1062-6050-52.3.13. Epub 2017 May 1.

    PMID: 28459281BACKGROUND
  • Finta R, Nagy E, Bender T. The effect of diaphragm training on lumbar stabilizer muscles: a new concept for improving segmental stability in the case of low back pain. J Pain Res. 2018 Nov 28;11:3031-3045. doi: 10.2147/JPR.S181610. eCollection 2018.

    PMID: 30568484BACKGROUND

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
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD., Assistant Professor

Study Record Dates

First Submitted

September 12, 2020

First Posted

September 18, 2020

Study Start

September 12, 2020

Primary Completion

December 20, 2020

Study Completion

January 8, 2021

Last Updated

January 12, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations