Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04554563
Other study ID # USG TrA MF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 12, 2020
Est. completion date January 8, 2021

Study information

Verified date January 2021
Source University School of Physical Education in Wroclaw
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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 (TrA) and multifidus (MF) muscles. To assess these structures several methods can be applied, e.g. sonofeedback. All participants will be randomly divided into two groups: 1. Training group (TG) 2. Control group (CG) Outcome measure: Pre- and post-therapy outcome measure will be done. It will include: - ultrasound (sonofeedback) of the TrA and MF - Oswestry Disability Index questionnaire (ODI) - subjective pain scale - Numeric Rating Scale (NRS) Intervention: Core stability training including 4 exercise positions, each of 15 repetitions, 4 sets. Once a day, 5 times a week, 20 sessions in total (4 weeks). Our hypothesis claims that the core muscles morphology will change over the training process duration, in result, the analgesic effect will be achieved.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 8, 2021
Est. primary completion date December 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - low back pain - age from 18 to 30 years old - written consent of the participants Exclusion Criteria: - injuries of the spine - fractures of the spine - surgery interventions in the spine region prior to the study - psychiatric disorders - neurologic disorders

Study Design


Intervention

Other:
Core stability training
20 sessions of specific core stability exercise with no external loading.

Locations

Country Name City State
Poland Klinika Fizjoterapii Wroclaw Dolnoslaskie

Sponsors (1)

Lead Sponsor Collaborator
University School of Physical Education in Wroclaw

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View Citation

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. — View Citation

Massé-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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Ultrasound Non-invasive measure of the TrA and MF muscles 5 minutes
Primary Pain level Numeric Rating Scale. Picking the number on a scale from 0 to 10. 1 minute
Primary Questionnaire Oswestry Disability Index questionnaire - subjective disability measure throughout daily living activities. 5 minutes
See also
  Status Clinical Trial Phase
Completed NCT03916705 - Thoraco-Lumbar Fascia Mobility N/A
Completed NCT04007302 - Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Recruiting NCT03600207 - The Effect of Diaphragm Muscle Training on Chronic Low Back Pain N/A
Completed NCT04284982 - Periodized Resistance Training for Persistent Non-specific Low Back Pain N/A
Recruiting NCT05600543 - Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain N/A
Withdrawn NCT05410366 - Safe Harbors in Emergency Medicine, Specific Aim 3
Completed NCT03673436 - Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
Completed NCT02546466 - Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain N/A
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05156242 - Corticospinal and Motor Behavior Responses After Physical Therapy Intervention in Patients With Chronic Low Back Pain. N/A
Recruiting NCT04673773 - MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain. N/A
Completed NCT06049277 - Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain N/A
Completed NCT06049251 - ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises N/A
Completed NCT04980469 - A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle N/A
Completed NCT04055545 - High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects N/A
Recruiting NCT05944354 - Wearable Spine Health System for Military Readiness
Recruiting NCT05552248 - Assessment of the Safety and Performance of a Lumbar Belt
Completed NCT05801588 - Participating in T'ai Chi to Reduce Back Pain and Improve Quality of Life N/A
Completed NCT05811143 - Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.