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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05638997
• Other study ID #: GaziosmanpasaU_Erol_01
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2022
• Source: Tokat Gaziosmanpasa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 30, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Instrument assisted manipulation + Core exercises
The effect of Instrument assisted manipulation on chronic non-spesific low back pain
• Mulligan mobilization with movement + Core exercises
The effect of Mulligan mobilization with movement on chronic non-spesific low back pain
• Core exercises
The effect of core exercises on chronic non-spesific low back pain

Locations

Country	Name	City	State
Turkey	Faculty of Health Sciences, Tokat Gaziosmanpasa University	Tokat

Sponsors (1)

Lead Sponsor	Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from baseline fingertip-to-floor test at 2nd and 6th weeks	Lumbal flexibility	Baseline, 2nd week, 6th week
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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