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NCT Number: NCT07749898

Spinal Mobilization and Manipulation for Nonspecific Low Back Pain

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.

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Key information

Conditions

Non-specific Low Back Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ozel Mediworld

Istanbul, 34744, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal Mobilization and Manipulation

Other

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 response, and joint mobility assessment. All procedures were performed by the same physiotherapist with more than 10 years of clinical experience in orthopedic manual therapy, three times per week for six consecutive weeks.

Conventional Physiotherapy

Other

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 outcomes

  1. 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

  1. Functional disability measured using the Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: Baseline and after 6 weeks of intervention

    Functional disability will be assessed using the 24-item Roland-Morris Disability Questionnaire (RMDQ). Scores range from 0 to 24, with higher scores indicating greater disability.

  2. Fear-avoidance beliefs measured using the Fear-Avoidance Beliefs Questionnaire (FABQ)

    Time frame: Baseline and after 6 weeks of intervention

    Fear-avoidance beliefs will be evaluated using the Fear-Avoidance Beliefs Questionnaire (FABQ), including physical activity and work subscales. Higher scores indicate greater fear-avoidance beliefs.

  3. Lumbar range of motion

    Time frame: Baseline and after 6 weeks of intervention

    Lumbar flexion, extension, lateral flexion, and rotation will be measured using a universal goniometer. Three measurements will be obtained for each movement, and the mean value will be used for analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Yıldırım, PhD

CONTACT

[email protected]

+905399306460

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study 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

Acronym: SMM-LBP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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