NCT06156163

Brief Summary

Nonspecific low back pain is defined as low back pain that cannot be associated with a specific identified pathology. Many methods such as patient education, medical treatment, physical modalities, exercise, manual therapy, massage, traction and cognitive behavioral therapy are used in the treatment of nonspecific low back pain. Spinal stabilization exercises, which are among the therapeutic exercises, aim to improve and improve muscle control to compensate for any loss of muscle movement caused by degenerative changes or injury. Perturbation training, which is among the neuromuscular exercises, is an intervention that aims to improve the control of rapid balance reactions and involves repetitive postural distortions. In perturbation training, the surface is moved in multiple directions with different forces and moments. The aim of this exercise is to develop the stabilization response that will be created by stresses applied from different directions. It is believed that the number of motor units participating in contraction and proprioceptive input will increase with perturbation exercise. Although the number of studies on low back pain is quite limited, it has been stated that applications that provide perturbation can reduce the incidence of low back pain and provide improvement in neuromuscular control of spinal stability. In the light of these data, the aim of this study is to investigate the effects of perturbation training given in addition to the exercise program on trunk muscle endurance, pain, disability, functionality, fear avoidance beliefs and quality of life parameters in individuals with nonspecific low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Dec 2023

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

November 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

December 16, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

12 months

First QC Date

November 26, 2023

Last Update Submit

December 30, 2024

Conditions

Keywords

low back painnonspecific low back pain

Outcome Measures

Primary Outcomes (3)

  • Trunk extensor endurance test

    Individuals are asked to hang their trunks from the bed starting from the spina iliaca anterior superior and cross both arms on the shoulders. The legs are fixed by the practitioner over the gastrocnemius muscle. The test is started when the individuals maintain the horizontal position and the time they maintain the position is recorded in seconds.

    At baseline and after 8 weeks of intervention

  • Trunk flexor endurance test

    The participant is positioned by the tester with the knees and hips at 90 degrees, the body at 60 degrees, the hands in a crossed position on both shoulders, and the soles of the feet firmly on the ground. The time this position can be maintained is recorded in seconds.

    At baseline and after 8 weeks of intervention

  • Bilater side bridge endurance test

    For the left lateral plank test, the participants' feet are placed on top of each other, the right arm is perpendicular to the ground, the elbow is on the mat, the left arm is at chest level, and the left hand is on the right shoulder. When the individual is ready, he is asked to lift his hips with support from his elbows and feet. As soon as the test position is taken in which the shoulders, hips and feet are in the same direction, the time is started by the researcher. The period ends when the individual cannot maintain the position and body swings forward and backward.

    At baseline and after 8 weeks of intervention

Secondary Outcomes (6)

  • Pain intensity

    At baseline and after 8 weeks of intervention

  • Disability

    At baseline and after 8 weeks of intervention

  • Timed Up and Go Test

    At baseline and after 8 weeks of intervention

  • The Fear-Avoidance Beliefs Questionnaire (FABQ)

    At baseline and after 8 weeks of intervention

  • Health-related quality-of-life

    At baseline and after 8 weeks of intervention

  • +1 more secondary outcomes

Study Arms (2)

Perturbation Group

EXPERIMENTAL

Exercise program with progressive perturbation conditions

Other: Perturbation training

Exercise Group

ACTIVE COMPARATOR

Exercise program

Other: Exercise

Interventions

The exercise program will be applied 2 days/week for 8 weeks, with the addition of progressive perturbation conditions.

Perturbation Group

The exercise program will be applied 2 days/week for 8 weeks.

Exercise Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Nonspecific low back pain persisting for at least 3 months
  • Pain intensity at least 3 on VAS
  • Ability to perceive verbal and written Turkish instructions
  • Having signed the voluntary consent form

You may not qualify if:

  • History of spinal surgery/trauma
  • Low back cpain associated with other pathologies (Rheumatic diseases, malignancy, MS)
  • Having herniation at the level of sequestration and extrusion
  • Instability conditions such as spondylolysis and spondylolisthesis
  • Use of painkillers and antidepressants
  • Pregnancy
  • Obesity (BMI≥30kg/m²)
  • Orthopedic problems and chronic diseases that may prevent exercises
  • FTR/steroid injection application within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Buyukcekmece, 34500, Turkey (Türkiye)

Location

Related Publications (7)

  • George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.

    PMID: 34719942BACKGROUND
  • Fitzgerald GK, Axe MJ, Snyder-Mackler L. The efficacy of perturbation training in nonoperative anterior cruciate ligament rehabilitation programs for physical active individuals. Phys Ther. 2000 Feb;80(2):128-40.

    PMID: 10654060BACKGROUND
  • Schinkel-Ivy A, Huntley AH, Aqui A, Mansfield A. Does Perturbation-Based Balance Training Improve Control of Reactive Stepping in Individuals with Chronic Stroke? J Stroke Cerebrovasc Dis. 2019 Apr;28(4):935-943. doi: 10.1016/j.jstrokecerebrovasdis.2018.12.011. Epub 2019 Jan 7.

    PMID: 30630753BACKGROUND
  • Schafer R, Schafer H, Platen P. Perturbation-based trunk stabilization training in elite rowers: A pilot study. PLoS One. 2022 May 19;17(5):e0268699. doi: 10.1371/journal.pone.0268699. eCollection 2022.

    PMID: 35587490BACKGROUND
  • Arampatzis A, Schroll A, Catala MM, Laube G, Schuler S, Dreinhofer K. A random-perturbation therapy in chronic non-specific low-back pain patients: a randomised controlled trial. Eur J Appl Physiol. 2017 Dec;117(12):2547-2560. doi: 10.1007/s00421-017-3742-6. Epub 2017 Oct 19.

    PMID: 29052033BACKGROUND
  • Evans K, Refshauge KM, Adams R. Trunk muscle endurance tests: reliability, and gender differences in athletes. J Sci Med Sport. 2007 Dec;10(6):447-55. doi: 10.1016/j.jsams.2006.09.003. Epub 2006 Dec 1.

    PMID: 17141568BACKGROUND
  • Shamsi MB, Rezaei M, Zamanlou M, Sadeghi M, Pourahmadi MR. Does core stability exercise improve lumbopelvic stability (through endurance tests) more than general exercise in chronic low back pain? A quasi-randomized controlled trial. Physiother Theory Pract. 2016;32(3):171-8. doi: 10.3109/09593985.2015.1117550. Epub 2016 Feb 11.

    PMID: 26864057BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

November 26, 2023

First Posted

December 5, 2023

Study Start

December 16, 2023

Primary Completion

December 10, 2024

Study Completion

December 10, 2024

Last Updated

December 31, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations