Health TrialsbyHealthPanel

Spinal Mobilization and Manipulation for Nonspecific Low Back Pain

ConditionNon-Specific Low Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBiruni University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Structural spinal abnormalities.

Spinal infection or tumor.

Inflammatory spinal diseases.

Neurological disorders or neurological deficits.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spinal Mobilization and Manipulation

    Other intervention

    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 intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Conventional Physiotherapy GroupActive comparator 1 intervention
Group B: Conventional Physiotherapy + Spinal Mobilization and Manipulation GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pain intensity measured using the Visual Analog Scale (VAS)

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.

Time frame
Baseline and after 6 weeks of intervention

Secondary outcomes

1

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

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.

Time frame
Baseline and after 6 weeks of intervention
2

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

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.

Time frame
Baseline and after 6 weeks of intervention
3

Lumbar range of motion

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.

Time frame
Baseline and after 6 weeks of intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biruni University

Lead sponsor

Source ClinicalTrials.gov

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