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

NCT ID: NCT05638997

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-06-30

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.

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Instrument Assisted Manipulation Group

Instrument Assisted Manipulation + Core exercises

Group Type: EXPERIMENTAL

Instrument assisted manipulation + Core exercises

Intervention Type: OTHER

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

Mulligan Mobilization with Movement Group

Mulligan Mobilization with Movement + Core exercises

Group Type: EXPERIMENTAL

Mulligan mobilization with movement + Core exercises

Intervention Type: OTHER

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

Control group

Core exercises

Group Type: ACTIVE_COMPARATOR

Core exercises

Intervention Type: OTHER

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

Interventions

Instrument assisted manipulation + Core exercises

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

Intervention Type: OTHER

Mulligan mobilization with movement + Core exercises

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

Intervention Type: OTHER

Core exercises

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokat Gaziosmanpasa University

OTHER

Sponsor Role: lead

Responsible Party

Erkan Erol

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erkan Erol, PhD

Role: PRINCIPAL_INVESTIGATOR

Tokat Gaziosmanpaşa University

Locations

Faculty of Health Sciences, Tokat Gaziosmanpaşa University

Tokat Province, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GaziosmanpasaU_Erol_01

Identifier Type: -

Identifier Source: org_study_id