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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: Instrument assisted manipulation + Core exercises; Other: Mulligan mobilization with movement + Core exercises; Other: Core exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tokat, Turkey, 60250
    • Faculty of Health Sciences, Tokat Gaziosmanpaşa University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Instrument Assisted Manipulation Group; Instrument Assisted Manipulation + Core exercises	Other: Instrument assisted manipulation + Core exercises; The effect of Instrument assisted manipulation on chronic non-spesific low back pain
Experimental: Mulligan Mobilization with Movement Group; Mulligan Mobilization with Movement + Core exercises	Other: Mulligan mobilization with movement + Core exercises; The effect of Mulligan mobilization with movement on chronic non-spesific low back pain
Active Comparator: Control group; Core exercises	Other: Core exercises; The effect of core exercises on chronic non-spesific low back pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 2nd week, 6th week
Change from baseline fingertip-to-floor test at 2nd and 6th weeks	Lumbal flexibility	Baseline, 2nd week, 6th week
Change from baseline joint ROM measurement with digital inclinometer at 2nd and 6th weeks	Lumbal flexion, lumbal extension and lumbal lateral flexion	Baseline, 2nd week, 6th week
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	Baseline, 2nd week, 6th week
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.	Baseline, 2nd week, 6th week
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.	Baseline, 2nd week, 6th week
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.	Baseline, 2nd week, 6th week

Collaborators and Investigators

• Sponsor: Tokat Gaziosmanpasa University
• Investigators: Principal Investigator: Erkan Erol, PhD, Tokat Gaziosmanpaşa University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Estimate): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Physiotherapy; Chronic Low Back Pain; Mulligan; Instrument Assisted Manipulation; Core Exercise
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: GaziosmanpasaU_Erol_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No