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

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Instrument assisted manipulation + Core exercises
Mulligan mobilization with movement + Core exercises
Core exercises
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Chronic Low Back Pain, Physiotherapy, Mulligan, Instrument Assisted Manipulation, Core Exercise

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Faculty of Health Sciences, Tokat Gaziosmanpaşa University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Instrument Assisted Manipulation Group

Mulligan Mobilization with Movement Group

Control group

Arm Description

Instrument Assisted Manipulation + Core exercises

Mulligan Mobilization with Movement + Core exercises

Core exercises

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 16, 2022
Last Updated
November 24, 2022
Sponsor
Tokat Gaziosmanpasa University
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1. Study Identification

Unique Protocol Identification Number
NCT05638997
Brief Title
Effects of Different Treatment Methods Applied to Spine in Chronic Non-Spesific Low Back Pain
Official Title
Effects of Different Treatment Methods Applied to Spine in Chronic Non-Spesific Low Back Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Chronic Low Back Pain, Physiotherapy, Mulligan, Instrument Assisted Manipulation, Core Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Instrument Assisted Manipulation Group
Arm Type
Experimental
Arm Description
Instrument Assisted Manipulation + Core exercises
Arm Title
Mulligan Mobilization with Movement Group
Arm Type
Experimental
Arm Description
Mulligan Mobilization with Movement + Core exercises
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Core exercises
Intervention Type
Other
Intervention Name(s)
Instrument assisted manipulation + Core exercises
Intervention Description
The effect of Instrument assisted manipulation on chronic non-spesific low back pain
Intervention Type
Other
Intervention Name(s)
Mulligan mobilization with movement + Core exercises
Intervention Description
The effect of Mulligan mobilization with movement on chronic non-spesific low back pain
Intervention Type
Other
Intervention Name(s)
Core exercises
Intervention Description
The effect of core exercises on chronic non-spesific low back pain
Primary Outcome Measure Information:
Title
Change from baseline visual analogue scale at 2nd and 6th weeks
Description
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
Title
Change from baseline fingertip-to-floor test at 2nd and 6th weeks
Description
Lumbal flexibility
Time Frame
Baseline, 2nd week, 6th week
Title
Change from baseline joint ROM measurement with digital inclinometer at 2nd and 6th weeks
Description
Lumbal flexion, lumbal extension and lumbal lateral flexion
Time Frame
Baseline, 2nd week, 6th week
Title
Change from baseline proprioception measurement with digital inclinometer at 2nd and 6th weeks
Description
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
Title
Change from baseline Oswestry disability index at 2nd and 6th weeks
Description
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
Title
Change from baseline Roland Morris disability questionnaire at 2nd and 6th weeks
Description
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
Title
Change from baseline Fremantle back awareness questionnaire at 2nd and 6th weeks
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erkan Erol, PhD
Organizational Affiliation
Tokat Gaziosmanpaşa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences, Tokat Gaziosmanpaşa University
City
Tokat
ZIP/Postal Code
60250
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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