Non-specific Chronic Low Back PainNCT05928975
Manual Therapy Plus Pain Neuroscience Education With Integrated Motivational Interviewing in Individuals With Non-Specific Chronic Low Back Pain
A study testing MT+ PNE with MI and MT in people with Non-specific Chronic Low Back Pain, run by International Hellenic University at 1 site in Greece.
Trial summary
Non-specific chronic low back pain (NSCLBP) is characterized by persistent back pain that lasts longer than 12 weeks. This clinical trial aims to examine the short-term and long-term effects of adding Pain Neuroscience Education (PNE) with integrated Motivational Interviewing (MI) to a Manual Therapy (MT) program on… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Non-specific Chronic Low Back Pain
- What is being tested?
- MT+ PNE with MI and MT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 5 Jan 2023to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Duration of symptoms at least 12 weeks
- Reported pain intensity of 3 or greater according to the numeric pain rating scale (NPRS)
- Written consent to participate in the study
Who cannot join
- Neuropathic pain extending along the lower limb due to nerve root compression
- Previous spine surgery
- History of spine trauma or fracture
- Cancer
- Severe osteoporosis
- Spondylo-arthropathy
Show all 12Show fewer
- Spondylolisthesis
- Systemic inflammatory disease
- Illiterate individuals
- Diagnosed neurodegenerative diseases (e.g., Parkinson's)
- Epilepsy
- History of psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physiotherapy, Faculty of Health Sciences International Hellenic Universit
Thessaloniki, Sindos Thessaloníki, Greece, 57400
About this study
Official title: Effects of Manual Therapy Plus Pain Neuroscience Education With Integrated Motivational Interviewing on Pain, Disability, Kinesiophobia and Catastrophizing in Individuals With Non-Specific Chronic Low Back Pain: A Randomized Clinical Trial Study
Non-specific chronic low back pain (NSCLBP) is characterized by persistent back pain that lasts longer than 12 weeks. This clinical trial aims to examine the short-term and long-term effects of adding Pain Neuroscience Education (PNE) with integrated Motivational Interviewing (MI) to a Manual Therapy (MT) program on pain intensity, pressure pain threshold (PPT), back performance, disability, kinesiophobia, fear and avoidance, and catastrophizing in individuals suffering from NSCLBP. The study adopts a randomized, controlled, single-blind design, with a total of 60 participants randomly allocated to three groups. The first group will receive MT and PNE with MI, the second group will receive MT alone, and the control group (third group) will follow a home-based exercise program only. All interventions will last for 4 weeks. Outcome measures will be assessed at three time points: pre-intervention, at 4 weeks, and at 6 months. The statistical analysis of the results will use a two-factor analysis of variance with repeated measurements, and the statistical significance index will be set at p < 0.05.
Read the detailed description
Background: Non-specific chronic low back pain (NSCLBP) is characterized by persistent back pain that lasts longer than 12 weeks. Manual therapy (MT) is likely to exhibit short-term efficacy for NSCLBP and is recommended by clinical guidelines. Pain Neuroscience Education (PNE) is a method through which patients are taught how to alter their own pain perception using explanations, metaphors, and examples, aiming to reduce the perception of painful stimuli at the central nervous system level. Integrated Motivational Interviewing (MI) consists of a patient-centered communication approach that aims to elicit and enhance motivation for behavior change, guiding patients away from ambivalence and uncertainty.
Aim: To study the effects of adding PNE with MI to an MT program on pain, pressure pain threshold (PPT), disability, kinesiophobia, catastrophizing, fear and avoidance, and back performance in individuals suffering from NSCLBP..
Method: Sixty adults with NSCLBP will be randomly assigned into three groups of 20 people each. The first group will receive MT and PNE with integrated MI. The second group will follow MT without PNE with integrated MI. The third group (control) will receive a conventional home-based exercise program. Pain in the last 24 hours with the Numeric Pain Rating Scale (NPRS), functional ability with the Roland- Morris Disability Questionnaire (RMDQ), PPT in the lumbar region through pressure algometry, kinesiophobia with Tampa Scale for Kinesiophobia (TSK), Fear- Avoidance behavior with Fear- Avoidance Beliefs Questionnaire (FABQ), catastrophizing with Pain-Catastrophizing-Scale (PCS) and performance using the Back Performance Scale (BPS) will be evaluated at baseline, at the 4th week, and six months post-intervention..
Expected results: Manual therapy in combination with Pain Neuroscience Education have shown short term positive effects on pain, kinesiophobia and catastrophizing in individuals with non-specific low back pain. Combining Manual Therapy with Pain Neuroscience Education with integrated MI holds promise for achieving improved outcomes characterized by larger and longer-lasting effects.
- Conditions
- Non-specific Chronic Low Back Pain
- Being tested
- MT+ PNE with MI, MT, Control
- Keywords
- Non-specific Chronic Low Back pain, Manual therapy, Pain neuroscience education, Motivational Interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT+ PNE with MIOther
The manual therapy treatment approach entailed the management of symptoms based on the clinical judgment of the attending physiotherapist. The physiotherapist selectively employed techniques such as spinal mobilization/manipulation, soft tissue massage, supervised exercises and muscle and neural mobilization, while excluding the utilization of electrophysical modalities. The participants will receive 10 Manual Therapy sessions of 30 minutes within a period of 4 weeks.
The pain neuroscience education program is based on previous clinical studies and available educational materials and is enhanced by motivational interviewing techniques. The program consisted of 4 individualized educational sessions, each lasting 30 minutes. All key aspects of pain neurophysiology were explained and discussed. At the end of the first session, participants will be provided with informational handouts to support the educational process.
MTOther
Participants in this group will be given the same MT program as "MT + PNE with MI group" without the application of PNE.
ControlOther
The participants in the control group will be provided with written instructions for performing general exercises at home. These exercises will consist of gentle stretching exercises specifically targeting the low back muscles, as well as relief positions and breathing relaxation exercises.
| Study group | Role | What they receive |
|---|---|---|
| MT+ PNE with MI | Experimental | Participants allocated to this group will receive 10 sessions of MT, along with 4 sessions of PNE with MI, over a period of four weeks. Receives: Other: MT+ PNE with MI |
| MT | Experimental | Participants allocated to this group will receive 10 sessions of MT (without PNE with MI), over a period of four weeks. Receives: Other: MT |
| Control | Active comparator | Participants allocated to this group will engage in a home-based general exercise program. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in low back pain intensity with Numeric Pain Rating Scale (NPRS)
This tool is an eleven-point pain scale numbered from zero to 10. The left end of the scale corresponds to zero and is marked as "No pain", whereas the right end corresponds to 10 and is marked as "Maximum pain". Consequently, a higher value indicates more intense pain. The examinee is asked to choose an integer that best reflects the intensity of their pain. The NPRS is widely used to measure pain in both clinical practice and research, showing high test-retest reliability and high conceptual construct validity.
Measured: pre-intervention, 4th week, 6-month follow-up
Changes in Pressure Pain Threshold (PPT) with pressure algometry
Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. PPT will be assessed by a digital algometer and will be evaluated bilaterally in the quadratus lumborum muscle, in the sacroiliac joints, and paravertebrally in the L4-L5 intervertebral space. The metal rod of the algometer will be placed vertically on the site and the examiner will apply gradually increasing pressure at a rate of 1Kg/s. PPT is calculated in kg/cm2 (Imamura et al., 2016).
Measured: pre-intervention, 4th week, 6-month follow-up
Changes in functional capacity with the Greek Version of Roland-Morris Disability Questionnaire (RMDQ)
The functional ability of the participants will be evaluated with the Greek version of the Roland-Morris questionnaire, which consists of 24 questions related to daily activities that patients often report difficulty performing due to low back pain. Each positive answer earns one point and the final score is calculated by adding all the points. Therefore, the higher the score, the greater the restriction. The Greek version of the questionnaire shows satisfactory reliability and validity (ICC: 0.44-0.92) (Boscainos et al., 2003).
Measured: pre-intervention, 4th week, 6-month follow-up
Changes in Kinesiophobia with Tampa Scale for Kinesiophobia (TSK)
The assessment of kinesiophobia will be conducted using the Tampa Scale for Kinesiophobia (TSK), a 17-item questionnaire specifically designed to evaluate fear of movement and re-injury. This scale incorporates parameters related to injury and re-injury, as well as fear-avoidance behaviors in work-related activities. Participants rate each item on a 4-point Likert-type scale, ranging from 1 (definitely disagree) to 4 (completely agree). The total score on the TSK falls within the range of 17 to 68 points, with higher scores indicating a greater level of kinesiophobia. The minimal clinically important difference (MCID) for the TSK is reported to be 8 points.
Measured: pre-intervention, 4th week, 6-month follow-up
Changes in Fear- Avoidance behaviour with Fear- Avoidance Beliefs Questionnaire (FABQ)
The Fear-Avoidance Beliefs Questionnaire (FABQ) is a widely used assessment tool designed to measure individuals' beliefs about how physical activity and work-related activities may impact their pain and disability. It consists of fourteen items, which are scored on a 7-point Likert-type scale, ranging from "completely disagree" to "completely agree." The total score ranges from 0 to 96, with higher scores indicating stronger fear-avoidance beliefs.
Measured: pre-intervention, 4th week, 6-month follow-up
Changes in Catastrophizing with Pain-Catastrophizing-Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a widely utilized self-report questionnaire designed to assess the extent to which individuals engage in catastrophic thinking when experiencing pain. The PCS consists of 13 items, each describing different thoughts and feelings that individuals may experience when in pain. Participants rate the extent to which they experience each statement on a 5-point Likert-type scale, ranging from "not at all" to "all the time." The scale encompasses three main dimensions of catastrophizing: rumination, magnification, and helplessness.
Measured: pre-intervention, 4th week, 6-month follow-up
Changes in Performance was assessed using the Back Performance Scale (BPS)
Performance will be assessed using the Back Performance Scale (BPS) described by Strand, Moe-Nilssen, and Ljunggren (2002). The BPS includes 5 tests of trunk mobility (sock test, pick-up test, roll-up test, fingertip-to-floor test, and lift test). Each test is scored from 0 to 3 based on the observed level of physical performance, and total score ranges from 0 to 15 points. High score indicates poor performance.
Measured: pre-intervention, 4th week, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start5 Jan 2023
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Chronic Low Back PainStudies of the same condition, open and under way.
- 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
- Sixty participants with non-specific chronic low back pain will be randomly assigned to three groups of 20 each. The allocation of the sample to the groups will be performed using a randomization program (https://www.randomizer.org/) by an independent researcher. The first group will receive MT and PNE with MI, the second group will receive MT alone, while participants in the control group (third group) will follow a home-based exercise program. Participants of the two intervention groups will follow a total of 10 treatment sessions over a period of 4 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Hellenic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Lytras, International Hellenic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928975
- Sponsor's protocol ID
- EC-08/2022
- Status last verified
- Sep 2023
- First submitted
- 23 Jun 2023
- Last updated
- 29 Sep 2023
- 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 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Manual Therapy Plus Pain Neuroscience Education With Integrated Motivational Interviewing on Pain, Disability, Kinesiophobia and Catastrophizing in Individuals With Non-Specific Chronic Low Back Pain: A Randomized Clinical Trial Study
- ClinicalTrials.gov ID
- NCT05928975
- Acronym / sponsor ID
- EC-08/2022
- Conditions
- Non-specific Chronic Low Back Pain
- Keywords
- Non-specific Chronic Low Back pain, Manual therapy, Pain neuroscience education, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- International Hellenic UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 3 Jul 2023 (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.
Non-specific chronic low back pain (NSCLBP) is characterized by persistent back pain that lasts longer than 12 weeks. This clinical trial aims to examine the short-term and long-term effects of adding Pain Neuroscience Education (PNE) with integrated Motivational Interviewing (MI) to a Manual Therapy (MT) program on pain intensity, pressure pain threshold (PPT), back performance, disability, kinesiophobia, fear and avoidance, and catastrophizing in individuals suffering from NSCLBP. The study adopts a randomized, controlled, single-blind design, with a total of 60 participants randomly allocated to three groups. The first group will receive MT and PNE with MI, the second group will receive MT alone, and the control group (third group) will follow a home-based exercise program only. All interventions will last for 4 weeks. Outcome measures will be assessed at three time points: pre-intervention, at 4 weeks, and at 6 months. The statistical analysis of the results will use a two-factor analysis of variance with repeated measurements, and the statistical significance index will be set at p < 0.05.
Detailed description
Background: Non-specific chronic low back pain (NSCLBP) is characterized by persistent back pain that lasts longer than 12 weeks. Manual therapy (MT) is likely to exhibit short-term efficacy for NSCLBP and is recommended by clinical guidelines. Pain Neuroscience Education (PNE) is a method through which patients are taught how to alter their own pain perception using explanations, metaphors, and examples, aiming to reduce the perception of painful stimuli at the central nervous system level. Integrated Motivational Interviewing (MI) consists of a patient-centered communication approach that aims to elicit and enhance motivation for behavior change, guiding patients away from ambivalence and uncertainty.
Aim: To study the effects of adding PNE with MI to an MT program on pain, pressure pain threshold (PPT), disability, kinesiophobia, catastrophizing, fear and avoidance, and back performance in individuals suffering from NSCLBP..
Method: Sixty adults with NSCLBP will be randomly assigned into three groups of 20 people each. The first group will receive MT and PNE with integrated MI. The second group will follow MT without PNE with integrated MI. The third group (control) will receive a conventional home-based exercise program. Pain in the last 24 hours with the Numeric Pain Rating Scale (NPRS), functional ability with the Roland- Morris Disability Questionnaire (RMDQ), PPT in the lumbar region through pressure algometry, kinesiophobia with Tampa Scale for Kinesiophobia (TSK), Fear- Avoidance behavior with Fear- Avoidance Beliefs Questionnaire (FABQ), catastrophizing with Pain-Catastrophizing-Scale (PCS) and performance using the Back Performance Scale (BPS) will be evaluated at baseline, at the 4th week, and six months post-intervention..
Expected results: Manual therapy in combination with Pain Neuroscience Education have shown short term positive effects on pain, kinesiophobia and catastrophizing in individuals with non-specific low back pain. Combining Manual Therapy with Pain Neuroscience Education with integrated MI holds promise for achieving improved outcomes characterized by larger and longer-lasting effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Sixty participants with non-specific chronic low back pain will be randomly assigned to three groups of 20 each. The allocation of the sample to the groups will be performed using a randomization program (https://www.randomizer.org/) by an independent researcher. The first group will receive MT and PNE with MI, the second group will receive MT alone, while participants in the control group (third group) will follow a home-based exercise program. Participants of the two intervention groups will follow a total of 10 treatment sessions over a period of 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| MT+ PNE with MI | Experimental | Other: MT+ PNE with MIParticipants allocated to this group will receive 10 sessions of MT, along with 4 sessions of PNE with MI, over a period of four weeks. |
| MT | Experimental | Other: MTParticipants allocated to this group will receive 10 sessions of MT (without PNE with MI), over a period of four weeks. |
| Control | Active comparator | Other: ControlParticipants allocated to this group will engage in a home-based general exercise program. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Duration of symptoms at least 12 weeks
- Reported pain intensity of 3 or greater according to the numeric pain rating scale (NPRS)
- Written consent to participate in the study
Key exclusion criteria (12 listed)
- Neuropathic pain extending along the lower limb due to nerve root compression
- Previous spine surgery
- History of spine trauma or fracture
- Cancer
- Severe osteoporosis
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 |
|---|---|---|
| MT+ PNE with MIThe manual therapy treatment approach entailed the management of symptoms based on the clinical judgment of the attending physiotherapist. The physiotherapist selectively employed techniques such as spinal mobilization/manipulation, soft tissue massage, supervised exercises and muscle and neural mobilization, while excluding the utilization of electrophysical modalities. The participants will receive 10 Manual Therapy sessions of 30 minutes within a period of 4 weeks. The pain neuroscience education program is based on previous clinical studies and available educational materials and is enhanced by motivational interviewing techniques. The program consisted of 4 individualized educational sessions, each lasting 30 minutes. All key aspects of pain neurophysiology were explained and discussed. At the end of the first session, participants will be provided with informational handouts to support the educational process. | Other | MT+ PNE with MI |
| MTParticipants in this group will be given the same MT program as "MT + PNE with MI group" without the application of PNE. | Other | MT |
| ControlThe participants in the control group will be provided with written instructions for performing general exercises at home. These exercises will consist of gentle stretching exercises specifically targeting the low back muscles, as well as relief positions and breathing relaxation exercises. | Other | Control |
Primary outcome
Changes in low back pain intensity with Numeric Pain Rating Scale (NPRS)
Time frame: pre-intervention, 4th week, 6-month follow-up
This tool is an eleven-point pain scale numbered from zero to 10. The left end of the scale corresponds to zero and is marked as "No pain", whereas the right end corresponds to 10 and is marked as "Maximum pain". Consequently, a higher value indicates more intense pain. The examinee is asked to choose an integer that best reflects the intensity of their pain. The NPRS is widely used to measure pain in both clinical practice and research, showing high test-retest reliability and high conceptual construct validity.
Changes in Pressure Pain Threshold (PPT) with pressure algometry
Time frame: pre-intervention, 4th week, 6-month follow-up
Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. PPT will be assessed by a digital algometer and will be evaluated bilaterally in the quadratus lumborum muscle, in the sacroiliac joints, and paravertebrally in the L4-L5 intervertebral space. The metal rod of the algometer will be placed vertically on the site and the examiner will apply gradually increasing pressure at a rate of 1Kg/s. PPT is calculated in kg/cm2 (Imamura et al., 2016).
Changes in functional capacity with the Greek Version of Roland-Morris Disability Questionnaire (RMDQ)
Time frame: pre-intervention, 4th week, 6-month follow-up
The functional ability of the participants will be evaluated with the Greek version of the Roland-Morris questionnaire, which consists of 24 questions related to daily activities that patients often report difficulty performing due to low back pain. Each positive answer earns one point and the final score is calculated by adding all the points. Therefore, the higher the score, the greater the restriction. The Greek version of the questionnaire shows satisfactory reliability and validity (ICC: 0.44-0.92) (Boscainos et al., 2003).
Changes in Kinesiophobia with Tampa Scale for Kinesiophobia (TSK)
Time frame: pre-intervention, 4th week, 6-month follow-up
The assessment of kinesiophobia will be conducted using the Tampa Scale for Kinesiophobia (TSK), a 17-item questionnaire specifically designed to evaluate fear of movement and re-injury. This scale incorporates parameters related to injury and re-injury, as well as fear-avoidance behaviors in work-related activities. Participants rate each item on a 4-point Likert-type scale, ranging from 1 (definitely disagree) to 4 (completely agree). The total score on the TSK falls within the range of 17 to 68 points, with higher scores indicating a greater level of kinesiophobia. The minimal clinically important difference (MCID) for the TSK is reported to be 8 points.
Changes in Fear- Avoidance behaviour with Fear- Avoidance Beliefs Questionnaire (FABQ)
Time frame: pre-intervention, 4th week, 6-month follow-up
The Fear-Avoidance Beliefs Questionnaire (FABQ) is a widely used assessment tool designed to measure individuals' beliefs about how physical activity and work-related activities may impact their pain and disability. It consists of fourteen items, which are scored on a 7-point Likert-type scale, ranging from "completely disagree" to "completely agree." The total score ranges from 0 to 96, with higher scores indicating stronger fear-avoidance beliefs.
Changes in Catastrophizing with Pain-Catastrophizing-Scale (PCS)
Time frame: pre-intervention, 4th week, 6-month follow-up
The Pain Catastrophizing Scale (PCS) is a widely utilized self-report questionnaire designed to assess the extent to which individuals engage in catastrophic thinking when experiencing pain. The PCS consists of 13 items, each describing different thoughts and feelings that individuals may experience when in pain. Participants rate the extent to which they experience each statement on a 5-point Likert-type scale, ranging from "not at all" to "all the time." The scale encompasses three main dimensions of catastrophizing: rumination, magnification, and helplessness.
Changes in Performance was assessed using the Back Performance Scale (BPS)
Time frame: pre-intervention, 4th week, 6-month follow-up
Performance will be assessed using the Back Performance Scale (BPS) described by Strand, Moe-Nilssen, and Ljunggren (2002). The BPS includes 5 tests of trunk mobility (sock test, pick-up test, roll-up test, fingertip-to-floor test, and lift test). Each test is scored from 0 to 3 based on the observed level of physical performance, and total score ranges from 0 to 15 points. High score indicates poor performance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MT+ PNE with MI and MT in people with Non-specific Chronic Low Back Pain, run by International Hellenic University at 1 site in Greece.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 29 Sep 2023. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in low back pain intensity with Numeric Pain Rating Scale (NPRS) (time frame: pre-intervention, 4th week, 6-month follow-up). The study lists 7 primary outcomes in all. 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 29 Sep 2023.