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Completed

NCT Number: NCT05638997

Effects of Different Treatment Methods Applied to Spine in Chronic Non-Spesific Low Back Pain

We aimed to investigate the effects of instrument assisted manipulation (IAM) and Mulligan mobilization with movement (MWM) on joint range of motion (ROM), pain, proprioception, endurance, back awareness and disability in individuals with chronic non-specific low back pain (CNSLBP). Fifthy one participants were randomly divided into 3 groups. The first was the Mulligan group, the second was the IAM group, and the third was the core exercise group. Visual Analogue Scale (VAS) was used to assess pain severity. Lumbal flexibility was evaluated with the fingertip-to-floor test. Oswestry disability index (ODI) and Roland Morris Disability Questionnaire (RMDQ) used to evaluate the disability. Fremantle back awareness questionnaire (FBAQ) used to evaluate back awareness. Joint ROM (lumbal flexion, lumbal extension and lumbal lateral flexion) and proprioception (30° lumbal flexion in standing, 30° lumbal flexion in sitting, 15° lumbal extension standing and lumbal neutral position) evaluated with JTECH digital dual inclinometer. McGill core endurance tests were used for core endurance assessment. McGill core endurance assessment consists of 3 tests. These: Flexor endurance test, lateral endurance test and extensor endurance test.

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Key information

Conditions

Chronic Low-back Pain

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences, Tokat Gaziosmanpaşa University

Tokat Province, 60250, Turkey (Türkiye)

About this study

IAM and Mulligan MWM interventions were applied 3 days a week for 2 weeks in total 6 sessions. All 3 groups did same core exercise program. The exercise program was done from the baseline for 6 weeks, 3 days a week, for a total of 18 sessions. Outcome measurements were done at baseline, at the end of the 2nd week, and at the end of the 6th week. The researcher who performed the outcome measurements did not know the participant's group. Assessment and treatment were performed by two different researchers with 8 years of professional experience. Visual Analogue Scale (VAS) was used to assess pain severity. Lumbal flexibility was evaluated with the fingertip-to-floor test. Oswestry disability index (ODI) and Roland Morris Disability Questionnaire (RMDQ) used to evaluate the disability. Fremantle back awareness questionnaire (FBAQ) used to evaluate back awareness. Joint ROM (lumbal flexion, lumbal extension and lumbal lateral flexion) and proprioception (30° lumbal flexion in standing, 30° lumbal flexion in sitting, 15° lumbal extension standing and lumbal neutral position) evaluated with JTECH digital dual inclinometer. The measurement of the joint ROM in the lumbal region with the dual inclinometer technique is a reliable method. McGill core endurance tests were used for core endurance assessment. McGill core endurance assessment consists of 3 tests. These: Flexor endurance test, lateral endurance test and extensor endurance test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • LBP for at least 3 months
  • Diagnosis of non-specific LBP
  • 20-55 ages.

Exclusion criteria

  • Red flag symptoms related to LBP
  • Neurological findings
  • Pain radiating to the leg
  • Undergone spinal surgery
  • Pathology of the spine (fracture, tumor, spondylolisthesis, spinal stenosis, cauda equina syndrome).

Treatment and study plan

Instrument assisted manipulation + Core exercises

Other

The effect of Instrument assisted manipulation on chronic non-spesific low back pain

Mulligan mobilization with movement + Core exercises

Other

The effect of Mulligan mobilization with movement on chronic non-spesific low back pain

core exercises

Other

The effect of core exercises on chronic non-spesific low back pain

Primary outcomes

  1. Change from baseline visual analogue scale at 2nd and 6th weeks

    Time frame: Baseline, 2nd week, 6th week

    Pain assessment. The minimum score of the visual analogue scale is 0, and the maximum score is 10. Higher scores indicate worse outcome.

  2. Change from baseline fingertip-to-floor test at 2nd and 6th weeks

    Time frame: Baseline, 2nd week, 6th week

    Lumbal flexibility

  3. Change from baseline joint ROM measurement with digital inclinometer at 2nd and 6th weeks

    Time frame: Baseline, 2nd week, 6th week

    Lumbal flexion, lumbal extension and lumbal lateral flexion

  4. Change from baseline proprioception measurement with digital inclinometer at 2nd and 6th weeks

    Time frame: Baseline, 2nd week, 6th week

    30° lumbal flexion in standing, 30° lumbal flexion in sitting, 15° lumbal extension standing and lumbal neutral position

  5. Change from baseline Oswestry disability index at 2nd and 6th weeks

    Time frame: Baseline, 2nd week, 6th week

    Disability assessment. The minimum score of the Oswestry disability index is 0, and the maximum score is 50. Higher scores indicate worse outcome.

  6. Change from baseline Roland Morris disability questionnaire at 2nd and 6th weeks

    Time frame: Baseline, 2nd week, 6th week

    Disability assessment. The minimum score of the Roland Morris disability questionnaire is 0, and the maximum score is 24. Higher scores indicate worse outcome.

  7. Change from baseline Fremantle back awareness questionnaire at 2nd and 6th weeks

    Time frame: Baseline, 2nd week, 6th week

    Back awareness assessment. The minimum score of the Fremantle back awareness questionnaire is 0, and the maximum score is 36. Higher scores indicate worse outcome.

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

Effects of Different Treatment Methods Applied to Spine in Chronic Non-Spesific Low Back Pain: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 6, 2022
Registry last updated
Dec 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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