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Not yet recruiting NCT07749898

Spinal Mobilization and Manipulation for Nonspecific Low Back Pain

No phase Interventional Non-Specific Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spinal Mobilization and Manipulation, Conventional Physiotherapy.
Who it may be relevant to
Registry conditions: Non-Specific Low Back Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Thirty participants with non-specific low back pain will be randomly allocated to either a conventional physiotherapy group or a conventional physiotherapy plus spinal mobilization and manipulation group. Both groups will receive conventional physiotherapy three times per week for six consecutive weeks. The intervention group will additionally receive spinal mobilization and spinal manipulation performed by an experienced physiotherapist.

Pain intensity will be assessed using the Visual Analog Scale (VAS), functional disability using the Roland-Morris Disability Questionnaire (RMDQ), fear-avoidance beliefs using the Fear-Avoidance Beliefs Questionnaire (FABQ), and lumbar range of motion using a universal goniometer. Outcome assessments will be performed at baseline and after completion of the six-week intervention.

Expected Outcomes

It is hypothesized that adding spinal mobilization and spinal manipulation to conventional physiotherapy will result in greater improvements in pain intensity, functional disability, fear-avoidance beliefs, and lumbar range of motion compared with conventional physiotherapy alone.

Interventions

  • Other Spinal Mobilization and Manipulation
    Spinal mobilization and spinal manipulation were administered sequentially during the same treatment session. Grade III central posterior-anterior oscillatory mobilization according to the Maitland concept was applied to the identified hypomobile lumbar segment, followed immediately by a high-velocity, low-amplitude (HVLA) rotational thrust manipulation performed in the side-lying position. The intervention was individualized according to each participant's clinical presentation, symptom respons
  • Other Conventional Physiotherapy
    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). The intervention was administered three times per week for six consecutive weeks, resulting in a total of 18 treatment sessions.

Primary outcome measures

  • Pain intensity measured using the Visual Analog Scale (VAS) [Time frame: Baseline and after 6 weeks of intervention]
Secondary outcome measures (3)
  • Functional disability measured using the Roland-Morris Disability Questionnaire (RMDQ) [Time frame: Baseline and after 6 weeks of intervention]
  • Fear-avoidance beliefs measured using the Fear-Avoidance Beliefs Questionnaire (FABQ) [Time frame: Baseline and after 6 weeks of intervention]
  • Lumbar range of motion [Time frame: Baseline and after 6 weeks of intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Ozel Mediworld — Istanbul

Identifiers

NCT: NCT07749898 · 1915

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗