Clinical trial NCT05638997: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Chronic Low Back Pain
Physiotherapy
Mulligan
Instrument Assisted Manipulation
Core Exercise
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change from baseline visual analogue scale at 2nd and 6th weeks
timeFrame: Baseline, 2nd week, 6th week
measure: Change from baseline fingertip-to-floor test at 2nd and 6th weeks
timeFrame: Baseline, 2nd week, 6th week
measure: Change from baseline joint ROM measurement with digital inclinometer at 2nd and 6th weeks
timeFrame: Baseline, 2nd week, 6th week
measure: Change from baseline proprioception measurement with digital inclinometer at 2nd and 6th weeks
timeFrame: Baseline, 2nd week, 6th week
measure: Change from baseline Oswestry disability index at 2nd and 6th weeks
timeFrame: Baseline, 2nd week, 6th week
measure: Change from baseline Roland Morris disability questionnaire at 2nd and 6th weeks
timeFrame: Baseline, 2nd week, 6th week
measure: Change from baseline Fremantle back awareness questionnaire at 2nd and 6th weeks
timeFrame: Baseline, 2nd week, 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Faculty of Health Sciences, Tokat Gaziosmanpaşa University
Study officials:
affiliation: Tokat Gaziosmanpaşa University
name: Erkan Erol, PhD
role: PRINCIPAL_INVESTIGATOR
References: