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

NCT05638997 | Completed

• 1 other identifier: GaziosmanpasaU_Erol_01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low-back Pain

Keywords

Chronic Low Back Pain; Physiotherapy; Mulligan; Instrument Assisted Manipulation; Core Exercise

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

Instrument Assisted Manipulation Group

EXPERIMENTAL

Instrument Assisted Manipulation + Core exercises

Other: Instrument assisted manipulation + Core exercises

Mulligan Mobilization with Movement Group

EXPERIMENTAL

Mulligan Mobilization with Movement + Core exercises

Other: Mulligan mobilization with movement + Core exercises

Control group

ACTIVE COMPARATOR

Core exercises

Other: Core exercises

Interventions

Instrument assisted manipulation + Core exercises OTHER

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

Instrument Assisted Manipulation Group

Mulligan mobilization with movement + Core exercises OTHER

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

Mulligan Mobilization with Movement Group

Core exercises OTHER

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

Control group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Faculty of Health Sciences, Tokat Gaziosmanpaşa University

Tokat Province, 60250, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Movement

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Erkan Erol, PhD

  Tokat Gaziosmanpaşa University

  PRINCIPAL INVESTIGATOR

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: Assistant Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 6, 2022
• Study Start: August 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: June 30, 2020
• Last Updated: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)