Non-Specific Low Back PainSMM-LBPNCT07749898
Spinal Mobilization and Manipulation for Nonspecific Low Back Pain
A study testing Spinal Mobilization and Manipulation and Conventional Physiotherapy in people with Non-Specific Low Back Pain, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Specific Low Back Pain
- What is being tested?
- Spinal Mobilization and Manipulation and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Structural spinal abnormalities.
- Spinal infection or tumor.
- Inflammatory spinal diseases.
- Neurological disorders or neurological deficits.
- Psychiatric disorders.
- Pregnancy.
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- History of recent spinal surgery.
- Chronic or systemic diseases that could affect participation.
- Conditions that could interfere with adherence to the treatment protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Non-Specific Low Back Pain
- Being tested
- Spinal Mobilization and Manipulation, Conventional Physiotherapy
- Keywords
- Spinal Mobilization, Spinal Manipulation, Conventional Physiotherapy, Non-Specific Low Back Pain, Manual Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Mobilization and ManipulationOther
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 PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Spinal Mobilization and Manipulation; Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 6 weeks of intervention
Secondary outcomes (3)
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.
Measured: Baseline and after 6 weeks of intervention
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.
Measured: Baseline and after 6 weeks of intervention
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.
Measured: Baseline and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Specific Low Back PainStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alyildirim, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749898
- Sponsor's protocol ID
- 1915
- Acronym
- SMM-LBP
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07749898
- Acronym / sponsor ID
- SMM-LBP / 1915
- Conditions
- Non-Specific Low Back Pain
- Keywords
- Spinal Mobilization, Spinal Manipulation, Conventional Physiotherapy, Non-Specific Low Back Pain, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy Group | Active comparator | Other: Conventional PhysiotherapyParticipants 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. |
| Conventional Physiotherapy + Spinal Mobilization and Manipulation Group | Experimental | Other: Spinal Mobilization and Manipulation, Other: Conventional PhysiotherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Structural spinal abnormalities.
- Spinal infection or tumor.
- Inflammatory spinal diseases.
- Neurological disorders or neurological deficits.
- Psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Mobilization and ManipulationSpinal 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. | Other | Conventional Physiotherapy + Spinal Mobilization and Manipulation Group |
| Conventional PhysiotherapyParticipants 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. | Other | Conventional Physiotherapy + Spinal Mobilization and Manipulation Group, Conventional Physiotherapy Group |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Mobilization and Manipulation and Conventional Physiotherapy in people with Non-Specific Low Back Pain, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Yıldırım, PhD (+905399306460, devri-alem-61@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured using the Visual Analog Scale (VAS) (time frame: Baseline and after 6 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.