CClinicalTrials.gg
CompletedNCT05638997Updated Dec 6, 2022

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

An interventional study of Instrument assisted manipulation + Core exercises and Mulligan mobilization with movement + Core exercises in Chronic Low-back Pain, sponsored by Tokat Gaziosmanpasa University. Completed at 1 site in Turkey. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-12-06.

Sponsored by Tokat Gaziosmanpasa University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Aug 2019, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Chronic Low-back Pain

Keywords

  • Chronic Low Back Pain
  • Physiotherapy
  • Mulligan
  • Instrument Assisted Manipulation
  • Core Exercise
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 51 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Tokat Gaziosmanpasa University is the lead sponsor of 164 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Instrument Assisted Manipulation Group

    Instrument Assisted Manipulation + Core exercises

    Other: Instrument assisted manipulation + Core exercises

  • Experimental
    Mulligan Mobilization with Movement Group

    Mulligan Mobilization with Movement + Core exercises

    Other: Mulligan mobilization with movement + Core exercises

  • Active comparator
    Control group

    Core exercises

    Other: Core exercises

Interventions

  • OtherInstrument assisted manipulation + Core exercises

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

  • OtherMulligan mobilization with movement + Core exercises

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

  • OtherCore exercises

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

06

What researchers measure

Primary outcomes

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

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

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

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

    Lumbal flexibility

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

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

    Lumbal flexion, lumbal extension and lumbal lateral flexion

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

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

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

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

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

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

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

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

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

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

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

    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.

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

07

Study locations

1 site
  • Faculty of Health Sciences, Tokat Gaziosmanpaşa University
    Tokat, 60250, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05638997
Lead sponsor
Tokat Gaziosmanpasa University
Responsible party
Erkan Erol (Assistant Professor, Tokat Gaziosmanpasa University) — Principal investigator
First posted
Dec 6, 2022
Start date
Aug 1, 2019
Primary completion
Feb 28, 2020
Completion
Jun 30, 2020
Last update
Dec 6, 2022

Study contacts

Erkan Erol, PhD
principal investigator · Tokat Gaziosmanpaşa University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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