Effectiveness of Perturbation Training in Nonspecific Low Back Pain

Sponsor
Istanbul Arel University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06156163
Collaborator
(none)
40
1
2
9
4.4

Study Details

Study Description

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, in our study, we aimed to investigate the effects of perturbation training in addition to the exercise program on pain, disability, trunk muscle endurance, functionality, fear avoidance beliefs and quality of life parameters in people with nonspecific low back pain.

Condition or Disease Intervention/Treatment Phase
  • Other: Perturbation training
  • Other: Exercise
N/A

Detailed Description

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. In current guidelines, it has been reported that patient education and therapeutic exercises are treatment methods with a high level of evidence. 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. With stabilization exercises, deep muscles are activated while excessive activity of superficial muscles is reduced. Thus, correcting muscle abnormalities and ensuring the correct function of the muscles supports the spine. 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. Previous studies have shown that the effects of perturbation training were mostly investigated in geriatric and neurological patient groups. However, current studies show that perturbation training is also applied to some orthopedic problems such as anterior cruciate ligament injury, shoulder pain, ankle instability and makes positive contributions to the healing process.

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, in our study, we aimed to investigate the effects of perturbation training in addition to the exercise program on pain, disability, trunk muscle endurance, functionality, fear avoidance beliefs and quality of life parameters in people with nonspecific low back pain.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Perturbation Training in Nonspecific Low Back Pain
Anticipated Study Start Date :
Dec 15, 2023
Anticipated Primary Completion Date :
Sep 15, 2024
Anticipated Study Completion Date :
Sep 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Perturbation Group

Exercise program with progressive perturbation conditions

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

Active Comparator: Exercise Group

Exercise program

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

Outcome Measures

Primary Outcome Measures

  1. Trunk extensor endurance test [At baseline and after 8 weeks of intervention]

    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.

  2. Trunk flexor endurance test [At baseline and after 8 weeks of intervention]

    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.

  3. Bilater side bridge endurance test [At baseline and after 8 weeks of intervention]

    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.

Secondary Outcome Measures

  1. Pain intensity [At baseline and after 8 weeks of intervention]

    The pain felt by the participants at rest, during activity and at night will be questioned with the "0-10 cm" Visual Analogue Scale (VAS). On VAS, 0 means "no pain" and 10 means "worst pain ever felt".

  2. Disability [At baseline and after 8 weeks of intervention]

    The disability levels of the participants will be evaluated with the 'Oswestry Disability Index (ODS)'. The survey contains 10 questions on 10 topics with 6 options. The increase in the total score is proportional to the increase in activity limitation.

  3. Timed Up and Go Test [At baseline and after 8 weeks of intervention]

    The 3-meter area in front of the chair is determined. The patient is asked to get up from the chair, walk this distance and sit down again. The elapsed time gives the result of the test and the time is recorded in seconds. The test is performed twice with a 1-minute interval and the average time is taken.

  4. Fear Avoidance Beliefs Questionnaire [At baseline and after 8 weeks of intervention]

    The first part of the survey, which consists of 16 questions and 2 parts, includes physical activity and the second part includes beliefs about work.

  5. Health-related quality-of-life [At baseline and after 8 weeks of intervention]

    Individuals' health-related quality of life will be evaluated with Short Form-12/SF-12. With SF-12, two subscores are obtained: physical component summary (PBS) and mental component summary (MBS). While the FBÖ-12 score is obtained from the sub-dimensions of general health, physical functionality, physical role and body pain, the MBÖ-12 score is obtained from the social functionality, emotional role, mental health and energy sub-dimensions. Both FBÖ-12 and MBÖ-12 scores range from 0 to 100, with a higher score representing better health.

  6. Patient Satisfaction [After 8 weeks of intervention]

    Patient satisfaction with the treatment will be evaluated with the Global Rating of Change scale. Participants will be asked to rate their condition compared to baseline after an 8-week intervention period, indicating whether they had significantly improved, slightly improved, remained unchanged, slightly deteriorated, or significantly worsened in this study.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University-Cerrahpasa Istanbul Buyukcekmece Turkey 34500

Sponsors and Collaborators

  • Istanbul Arel University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tuğba Akgüller, lecturer, Istanbul Arel University
ClinicalTrials.gov Identifier:
NCT06156163
Other Study ID Numbers:
  • takguller
First Posted:
Dec 5, 2023
Last Update Posted:
Dec 5, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tuğba Akgüller, lecturer, Istanbul Arel University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2023