Spinal Mobilization and Manipulation for Nonspecific Low Back Pain

NCT07749898 | Not Yet Recruiting

• 1 other identifier: 1915
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Specific Low Back Pain

Keywords

Spinal Mobilization; Spinal Manipulation; Conventional Physiotherapy; Non-Specific Low Back Pain; Manual Therapy

Outcome Measures

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.

  Baseline and after 6 weeks of intervention

Secondary Outcomes (3)

• 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

Study Arms (2)

Conventional Physiotherapy Group

ACTIVE COMPARATOR

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.

Other: Conventional Physiotherapy

Conventional Physiotherapy + Spinal Mobilization and Manipulation Group

EXPERIMENTAL

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.

Other: Spinal Mobilization and Manipulation; Other: Conventional Physiotherapy

Interventions

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 + Spinal Mobilization and Manipulation Group

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.

Conventional Physiotherapy + Spinal Mobilization and Manipulation Group; Conventional Physiotherapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Ozel Mediworld

Istanbul, 34744, Turkey (Türkiye)

Location

Central Study Contacts

Ali Yıldırım, PhD

CONTACT

+905399306460; devri-alem-61@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, parallel-group, randomized controlled trial with two intervention arms. Participants will be randomly assigned in a 1:1 ratio to receive either conventional physiotherapy alone or conventional physiotherapy combined with spinal mobilization and spinal manipulation. Outcome measures will be assessed at baseline and after completion of the six-week intervention.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)