Effects of Spinal Mobilization and Manipulation Added to Conventional Physiotherapy on Pain Intensity, Functional Disability, Fear-Avoidance Beliefs, and Lumbar Range of Motion in Individuals With Non-Specific Low Back Pain: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pain intensity measured using the Visual Analog Scale (VAS)
Study Overview
Brief Summary
Low back pain is one of the most common musculoskeletal disorders worldwide and is a major cause of pain and disability. Manual therapy techniques such as spinal mobilization and spinal manipulation are frequently used together with conventional physiotherapy; however, their additional benefits remain unclear.
This randomized controlled trial aims to investigate whether adding spinal mobilization and spinal manipulation to conventional physiotherapy improves pain intensity, functional disability, fear-avoidance beliefs, and lumbar range of motion in individuals with non-specific low back pain. Participants will be randomly assigned to receive either conventional physiotherapy alone or conventional physiotherapy combined with spinal mobilization and manipulation. Outcome measures will be assessed before and after the six-week intervention. The findings of this study may provide evidence regarding the effectiveness of combining manual therapy with conventional physiotherapy for the management of non-specific low back pain.
Detailed Description
Background
Non-specific low back pain is one of the leading causes of disability worldwide and is associated with substantial physical, psychological, and socioeconomic burden. Conservative physiotherapy is recommended as the first-line treatment, and manual therapy techniques such as spinal mobilization and spinal manipulation are frequently used as adjunctive interventions. However, evidence regarding their additional effectiveness when combined with conventional physiotherapy remains limited.
Objective
The aim of this randomized controlled trial is to investigate the effects of spinal mobilization and manipulation in addition to conventional physiotherapy on pain intensity, functional disability, fear-avoidance beliefs, and lumbar range of motion in individuals with non-specific low back pain.
Methods
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessments were performed by an independent assessor who was blinded to group allocation. Due to the nature of the interventions, participants, care providers, and investigators were not blinded.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 to 60 years.
- •Diagnosis of non-specific low back pain.
- •Symptoms persisting for more than 12 weeks.
- •Able to understand the study procedures and provide written informed consent.
- •Willing to participate in the study and comply with the intervention protocol
Exclusion Criteria
- •Structural spinal abnormalities.
- •Spinal infection or tumor.
- •Inflammatory spinal diseases.
- •Neurological disorders or neurological deficits.
- •Psychiatric disorders.
- •Pregnancy.
- •History of recent spinal surgery.
- •Chronic or systemic diseases that could affect participation.
- •Conditions that could interfere with adherence to the treatment protocol
Arms & Interventions
Conventional Physiotherapy Group
Participants received conventional physiotherapy consisting of superficial heat application using a hot pack (20 minutes), transcutaneous electrical nerve stimulation (TENS) (20 minutes), therapeutic ultrasound (5 minutes), and supervised therapeutic exercises (20 minutes), administered three times per week for six consecutive weeks.
Intervention: Conventional Physiotherapy (Other)
Conventional Physiotherapy + Spinal Mobilization and Manipulation Group
Participants received the same conventional physiotherapy program as the active comparator group. In addition, spinal mobilization according to the Maitland concept and high-velocity, low-amplitude (HVLA) spinal manipulation were applied by an experienced physiotherapist three times per week for six consecutive weeks.
Intervention: Spinal Mobilization and Manipulation (Other)
Conventional Physiotherapy + Spinal Mobilization and Manipulation Group
Participants received the same conventional physiotherapy program as the active comparator group. In addition, spinal mobilization according to the Maitland concept and high-velocity, low-amplitude (HVLA) spinal manipulation were applied by an experienced physiotherapist three times per week for six consecutive weeks.
Intervention: Conventional Physiotherapy (Other)
Outcomes
Primary Outcomes
Pain intensity measured using the Visual Analog Scale (VAS)
Time Frame: Baseline and after 6 weeks of intervention
Pain intensity will be assessed under three conditions (at rest, during activity, and at night) using a 10-cm Visual Analog Scale (VAS). Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
Secondary Outcomes
- Functional disability measured using the Roland-Morris Disability Questionnaire (RMDQ)(Baseline and after 6 weeks of intervention)
- Fear-avoidance beliefs measured using the Fear-Avoidance Beliefs Questionnaire (FABQ)(Baseline and after 6 weeks of intervention)
- Lumbar range of motion(Baseline and after 6 weeks of intervention)
Investigators
alyildirim
Principal Investigator
Biruni University