Low Back PainNCT07306312
Psychological Predictors of Pain and Disability in Patients With Chronic Low Back Pain After Manual Therapy
A study testing Manual therapy and Manual therapy plus Pain Neuroscience Education in people with Low Back Pain and Disability Physical, run by University of Thessaly at 1 site in Greece.
Trial summary
Low back pain has been reported to cause more disability than any other musculoskeletal health condition worldwide. About eight out of ten people will experience back pain at least once in their lifetime. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Disability Physical, Manual Theapy
- What is being tested?
- Manual therapy and Manual therapy plus Pain Neuroscience Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 10 Dec 2025to 31 Dec 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
- Participants should be between 18 and 65 years of age,
- the pain in the lumbar region should last for more than 3 months, with at least one attack per week,
- they should not have undergone physiotherapy in the last 6 months prior to the intervention
- have a good knowledge of the Greek language and an adequate level of knowledge, to be informed and sign the consent form and questionnaires
Who cannot join
- people with clinical conditions that are contraindicated for physiotherapy,
- patients who report red flags,
- people with a history of lumbar surgery,
- people with diagnosed neuromuscular diseases that significantly impair movement,
- people with cardiovascular and respiratory diseases that cause severe shortness of breath or angina
- people with mental disorders, as long as they hinder communication and cooperation with the researcher.
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
Low back pain has been reported to cause more disability than any other musculoskeletal health condition worldwide. About eight out of ten people will experience back pain at least once in their lifetime. The parameters that are usually evaluated in a low back pain condition are pain, functional disability and range of motion of the lumbar spine. There are studies that associate psychological conditions (self-efficacy, kinesiophobia, catastrophology, depression, anxiety) with pain and functional disability in patients with low back pain. However, the ability of psychological factors to predict progression after a program of physical therapy or therapeutic methods is not well studied.
The main purpose of this study is to investigate the predictive potential of psychological factors in the improvement of pain and functional disability after a manual therapy physiotherapy program in patients with chronic low back pain. A secondary purpose is to investigate the predictive potential of psychological factors in the improvement of pain and functional disability following a program of Pain Neuroscience Education (PNE) in patients with chronic low back pain. In addition, as a secondary purpose, it will be to investigate the effect of combining manual therapy therapy with PNE compared to manual therapy alone in patients with chronic low back pain.
This study will involve 60 people aged 18-65 with chronic low back pain, who will be randomly divided by lots into 2 groups of 30 people. The 1st group (30 people) will be treated with manual therapy based on Maitland's principles (interview, evaluation, mobilization), without any use of physiotherapy machines, but with the use of personalized exercises. The 2nd group (30 people) will do the same as group 1 and additional volunteers will participate in before, in a training program in Pain Neuroscience Education (PNE). The total number of sessions that each volunteer will receive will be 6, the duration of each session will be about 45 minutes, the frequency of the sessions will be 2 times a week and the total duration of the intervention will be 3 weeks. The associations between psychological states and clinical characteristics (pain, disability and range of motion) will be carried out with the Pearson or Spearman correlation coefficient depending on whether the data are parametric or not. Multiple regression models will also be created with predictive factors for psychological states and a predictive variable for each of the clinical parameters. The significance level will be set to p=0.05.
Read the detailed description
Sample A total of 60 people with chronic low back pain will participate in the study and will be divided by lot into two groups of 30 people. The statistical calculation of the sample was made in the following way. We have 5 predictive factors (self-efficacy, depression, kinesiophobia, catastrophism and anxiety) and one predictive factor. According to the regression model we will need 10 people for each variable (i.e. 50 people). However, since we will divide the individuals into 2 groups, in order to have statistical strength in the measurements that will be made, we will take 30 people in each group Participants will be taken through convenience sampling. Participation in the survey will be voluntary and all those who take part will sign a consent form, after detailed information through the information form.
Equipment and Materials The equipment that will be used to conduct the study includes: a) a special electric manual therapy bed, adjustable in height, with recline and hole for the face b) two inclinometers to measure the range of motion of the lumbar spine, c) a mechanical algometer for measuring the pain threshold of the lumbar spine, d) specific questionnaires.
Interventions In both intervention groups, manual therapy based on Maitland's principles (interview, evaluation, mobilization) will be applied without the use of physiotherapy machines, but with the use of therapeutic exercise. The physiotherapist who will apply the techniques is a certified therapist of manual therapy Maitland Concept with 8 years of experience in the application of the method. The number of sessions that each volunteer will receive will be 6, the duration of each session will be about 45 minutes, the frequency of sessions will be 2 times a week and the total duration of the intervention will be 3 weeks.
The International Federation of Orthopaedic Manipulative Physical Therapists (IFOMPT) defines orthopaedic manual physical therapy as: "a specialized area of physiotherapy for the management of neuromusculoskeletal disorders, based on clinical reasoning, using very specific therapeutic approaches, including manual techniques and therapeutic exercises. Orthopedic hand-held physiotherapy also includes, and is guided by, the available scientific and clinical data and the biopsychosocial context of each individual patient".
The effectiveness of manual therapy in the treatment of low back pain (LBP) has been supported by various studies, indicating its potential benefits in reducing pain, improving impotence and trajectory range. Manual therapy includes techniques such as manipulation and mobilization, which have shown positive results in enhancing range of motion and relieving discomfort in patients with low back pain.
Treating low back pain through exercise has been shown to be an effective intervention, with various studies highlighting its benefits in reducing pain and improving functionality. Exercise therapy, including specific methods such as Pilates and trunk stabilization exercises, has been recognized as a safe and effective approach to managing low back pain.
The combination of manual therapy and exercise has been shown to be an effective treatment for low back pain, particularly in chronic cases. Research shows that this multimodal approach significantly improves pain perception, disability and overall functionality in patients suffering from chronic back pain.
In the 2nd group, training in Pain Neuroscience Education (PNE) will be applied. The implementation of the PNE will be done in the form of a short presentation through specific training images. The duration of the PNE will be approximately 5 minutes and will be incorporated into the total time of each session so that each session does not exceed 45 minutes, just like the session time of the 1st intervention group. A total of 6 sessions will be held with the PNE, as many as the total intervention sessions. PNE has emerged as an effective intervention for the management of chronic low back pain.
PNE focuses on teaching patients about how the nervous system works and how pain is created, the difference between acute and chronic pain, the role of the brain in pain perception, and how factors such as stress, hypersensitivity of the nervous system, and beliefs about pain can exacerbate it. The application of PNE can be done before, during or at the end of a physiotherapy intervention. We will apply the PNE before the physiotherapeutic intervention with manual therapy and exercise as it helps in the cognitive preparation of the patient. Educating patients about the mechanisms of pain before physical activity can help reduce movement-related anxiety and fear, promoting a more positive mindset toward rehabilitation. Also, patients who understand their pain have enhanced engagement and are more likely to actively participate in physical interventions, leading to better compliance and outcomes.
Measurements The 60 volunteers of the study, after being approved according to the inclusion criteria, will be randomly divided by lots into 2 groups of 30 people. The 1st group (30 people) will be treated with manual therapy based on Maitland's principles (interview, evaluation, mobilization - mobilization), without any use of physiotherapy machines but with the use of personalized exercises. The 2nd group (30 people) will do the same as group 1 and additional volunteers will participate before, in a Pain Neuroscience Education (PNE) program. The number of sessions that each volunteer will receive will be 6, the duration of each session will be about 45 minutes, the frequency of sessions will be 2 times a week and the total duration of the intervention will be 3 weeks.
Before the start of the interventions (Baseline), the form with the volunteer's demographic and somatometric data will be completed. The volunteer will then be given the self-reported questionnaires mentioned above, in order to complete them on their own. Then the measurement of the range of motion of the lumbar spine with the double inclinometer and the measurement of the pain of the lumbar spine with the mechanical algorithm will be performed.
In between the overall intervention, i.e. before the 4th session, only the questionnaire for the recording of pain will be given.
At the end of the intervention, i.e. after the 6th session, all the self-reported questionnaires given to the baseline will be given again, in order to complete them on their own. The range of motion of the lumbar spine will also be measured again with the double inclinometer and the measurement of the pain of the lumbar spine with the mechanical algometer.
Finally, after 6 months, the volunteers will be contacted by telephone in order to record only their pain and disability.
- Conditions
- Low Back Pain, Disability Physical, Manual Theapy
- Being tested
- Manual therapy, Manual therapy plus Pain Neuroscience Education
- Keywords
- pain, disability, manual therapy, low back pain, Pain Neuroscience Education, psychological factors, kinesiophobia, catastrophizing, anxiety, depression, self-efficacy
- Medical subject headings
- Low Back Pain, Pain, Kinesiophobia, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
Manual therapy based on Maitland's approach
Manual therapy plus Pain Neuroscience EducationOther
Manual therapy based on Maitland's approach with Pain Neuroscience Education
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy | Experimental | Participants with low back pain will be treated with manual therapy based on Maitland's principles Receives: Other: Manual therapy |
| Manual therapy plus Pain Neuroscience Education | Active comparator | Participants with low back pain will be treated with manual therapy based on Maitland's principles but before that, volunteers will be participated, in a Pain Neuroscience Education (PNE) program Receives: Other: Manual therapy plus Pain Neuroscience Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
The assessment of pain will be recorded with the Numeric Pain Rating Scale - NPRS questionnaire. "Zero is equivalent to no pain and 10 indicates the worst possible pain."
Measured: From enrollment to the end of treatment at 3 weeks and after 6 months from the enrollment
Secondary outcomes (1)
Disability
The assessment of disability will be recorded with the Oswestry Low Back Pain Disability Index - ODI questionnaire. The ODI questionnaire is a widely recognized patient-reported outcome measure designed to assess the degree of disability in people suffering from low back pain. It consists of 10 questions, which assess various aspects of daily life affected by pain, including personal care, lifting, walking, and social activities.
Measured: From enrollment to the end of treatment at 3 weeks and after 6 months from the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start10 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Prentzas, University of Thessaly
- Investigators
- Zacharias Dimitriadis, Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306312
- Sponsor's protocol ID
- 10130/25/TFSKTH - 04/04/25
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2025
- Last updated
- 18 Feb 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Predictors of Pain and Disability in Patients With Chronic Low Back Pain After Manual Therapy
- ClinicalTrials.gov ID
- NCT07306312
- Acronym / sponsor ID
- 10130/25/TFSKTH - 04/04/25
- Conditions
- Low Back Pain, Disability Physical, Manual Theapy
- Keywords
- pain, disability, manual therapy, low back pain, Pain Neuroscience Education, psychological factors, kinesiophobia, catastrophizing
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Dec 2025 (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 has been reported to cause more disability than any other musculoskeletal health condition worldwide. About eight out of ten people will experience back pain at least once in their lifetime. The parameters that are usually evaluated in a low back pain condition are pain, functional disability and range of motion of the lumbar spine. There are studies that associate psychological conditions (self-efficacy, kinesiophobia, catastrophology, depression, anxiety) with pain and functional disability in patients with low back pain. However, the ability of psychological factors to predict progression after a program of physical therapy or therapeutic methods is not well studied.
The main purpose of this study is to investigate the predictive potential of psychological factors in the improvement of pain and functional disability after a manual therapy physiotherapy program in patients with chronic low back pain. A secondary purpose is to investigate the predictive potential of psychological factors in the improvement of pain and functional disability following a program of Pain Neuroscience Education (PNE) in patients with chronic low back pain. In addition, as a secondary purpose, it will be to investigate the effect of combining manual therapy therapy with PNE compared to manual therapy alone in patients with chronic low back pain.
This study will involve 60 people aged 18-65 with chronic low back pain, who will be randomly divided by lots into 2 groups of 30 people. The 1st group (30 people) will be treated with manual therapy based on Maitland's principles (interview, evaluation, mobilization), without any use of physiotherapy machines, but with the use of personalized exercises. The 2nd group (30 people) will do the same as group 1 and additional volunteers will participate in before, in a training program in Pain Neuroscience Education (PNE). The total number of sessions that each volunteer will receive will be 6, the duration of each session will be about 45 minutes, the frequency of the sessions will be 2 times a week and the total duration of the intervention will be 3 weeks. The associations between psychological states and clinical characteristics (pain, disability and range of motion) will be carried out with the Pearson or Spearman correlation coefficient depending on whether the data are parametric or not. Multiple regression models will also be created with predictive factors for psychological states and a predictive variable for each of the clinical parameters. The significance level will be set to p=0.05.
Detailed description
Sample A total of 60 people with chronic low back pain will participate in the study and will be divided by lot into two groups of 30 people. The statistical calculation of the sample was made in the following way. We have 5 predictive factors (self-efficacy, depression, kinesiophobia, catastrophism and anxiety) and one predictive factor. According to the regression model we will need 10 people for each variable (i.e. 50 people). However, since we will divide the individuals into 2 groups, in order to have statistical strength in the measurements that will be made, we will take 30 people in each group Participants will be taken through convenience sampling. Participation in the survey will be voluntary and all those who take part will sign a consent form, after detailed information through the information form.
Equipment and Materials The equipment that will be used to conduct the study includes: a) a special electric manual therapy bed, adjustable in height, with recline and hole for the face b) two inclinometers to measure the range of motion of the lumbar spine, c) a mechanical algometer for measuring the pain threshold of the lumbar spine, d) specific questionnaires.
Interventions In both intervention groups, manual therapy based on Maitland's principles (interview, evaluation, mobilization) will be applied without the use of physiotherapy machines, but with the use of therapeutic exercise. The physiotherapist who will apply the techniques is a certified therapist of manual therapy Maitland Concept with 8 years of experience in the application of the method. The number of sessions that each volunteer will receive will be 6, the duration of each session will be about 45 minutes, the frequency of sessions will be 2 times a week and the total duration of the intervention will be 3 weeks.
The International Federation of Orthopaedic Manipulative Physical Therapists (IFOMPT) defines orthopaedic manual physical therapy as: "a specialized area of physiotherapy for the management of neuromusculoskeletal disorders, based on clinical reasoning, using very specific therapeutic approaches, including manual techniques and therapeutic exercises. Orthopedic hand-held physiotherapy also includes, and is guided by, the available scientific and clinical data and the biopsychosocial context of each individual patient".
The effectiveness of manual therapy in the treatment of low back pain (LBP) has been supported by various studies, indicating its potential benefits in reducing pain, improving impotence and trajectory range. Manual therapy includes techniques such as manipulation and mobilization, which have shown positive results in enhancing range of motion and relieving discomfort in patients with low back pain.
Treating low back pain through exercise has been shown to be an effective intervention, with various studies highlighting its benefits in reducing pain and improving functionality. Exercise therapy, including specific methods such as Pilates and trunk stabilization exercises, has been recognized as a safe and effective approach to managing low back pain.
The combination of manual therapy and exercise has been shown to be an effective treatment for low back pain, particularly in chronic cases. Research shows that this multimodal approach significantly improves pain perception, disability and overall functionality in patients suffering from chronic back pain.
In the 2nd group, training in Pain Neuroscience Education (PNE) will be applied. The implementation of the PNE will be done in the form of a short presentation through specific training images. The duration of the PNE will be approximately 5 minutes and will be incorporated into the total time of each session so that each session does not exceed 45 minutes, just like the session time of the 1st intervention group. A total of 6 sessions will be held with the PNE, as many as the total intervention sessions. PNE has emerged as an effective intervention for the management of chronic low back pain.
PNE focuses on teaching patients about how the nervous system works and how pain is created, the difference between acute and chronic pain, the role of the brain in pain perception, and how factors such as stress, hypersensitivity of the nervous system, and beliefs about pain can exacerbate it. The application of PNE can be done before, during or at the end of a physiotherapy intervention. We will apply the PNE before the physiotherapeutic intervention with manual therapy and exercise as it helps in the cognitive preparation of the patient. Educating patients about the mechanisms of pain before physical activity can help reduce movement-related anxiety and fear, promoting a more positive mindset toward rehabilitation. Also, patients who understand their pain have enhanced engagement and are more likely to actively participate in physical interventions, leading to better compliance and outcomes.
Measurements The 60 volunteers of the study, after being approved according to the inclusion criteria, will be randomly divided by lots into 2 groups of 30 people. The 1st group (30 people) will be treated with manual therapy based on Maitland's principles (interview, evaluation, mobilization - mobilization), without any use of physiotherapy machines but with the use of personalized exercises. The 2nd group (30 people) will do the same as group 1 and additional volunteers will participate before, in a Pain Neuroscience Education (PNE) program. The number of sessions that each volunteer will receive will be 6, the duration of each session will be about 45 minutes, the frequency of sessions will be 2 times a week and the total duration of the intervention will be 3 weeks.
Before the start of the interventions (Baseline), the form with the volunteer's demographic and somatometric data will be completed. The volunteer will then be given the self-reported questionnaires mentioned above, in order to complete them on their own. Then the measurement of the range of motion of the lumbar spine with the double inclinometer and the measurement of the pain of the lumbar spine with the mechanical algorithm will be performed.
In between the overall intervention, i.e. before the 4th session, only the questionnaire for the recording of pain will be given.
At the end of the intervention, i.e. after the 6th session, all the self-reported questionnaires given to the baseline will be given again, in order to complete them on their own. The range of motion of the lumbar spine will also be measured again with the double inclinometer and the measurement of the pain of the lumbar spine with the mechanical algometer.
Finally, after 6 months, the volunteers will be contacted by telephone in order to record only their pain and disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy | Experimental | Other: Manual therapyParticipants with low back pain will be treated with manual therapy based on Maitland's principles |
| Manual therapy plus Pain Neuroscience Education | Active comparator | Other: Manual therapy plus Pain Neuroscience EducationParticipants with low back pain will be treated with manual therapy based on Maitland's principles but before that, volunteers will be participated, in a Pain Neuroscience Education (PNE) program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants should be between 18 and 65 years of age,
- the pain in the lumbar region should last for more than 3 months, with at least one attack per week,
- they should not have undergone physiotherapy in the last 6 months prior to the intervention
- have a good knowledge of the Greek language and an adequate level of knowledge, to be informed and sign the consent form and questionnaires
Key exclusion criteria (6 listed)
- people with clinical conditions that are contraindicated for physiotherapy,
- patients who report red flags,
- people with a history of lumbar surgery,
- people with diagnosed neuromuscular diseases that significantly impair movement,
- people with cardiovascular and respiratory diseases that cause severe shortness of breath or angina
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 |
|---|---|---|
| Manual therapyManual therapy based on Maitland's approach | Other | Manual therapy |
| Manual therapy plus Pain Neuroscience EducationManual therapy based on Maitland's approach with Pain Neuroscience Education | Other | Manual therapy plus Pain Neuroscience Education |
Primary outcome
Pain intensity
Time frame: From enrollment to the end of treatment at 3 weeks and after 6 months from the enrollment
The assessment of pain will be recorded with the Numeric Pain Rating Scale - NPRS questionnaire. "Zero is equivalent to no pain and 10 indicates the worst possible pain."
1 secondary outcome
Disability
Time frame: From enrollment to the end of treatment at 3 weeks and after 6 months from the enrollment
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 18 Feb 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.
Zacharias Dimitriadis study director
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy and Manual therapy plus Pain Neuroscience Education in people with Low Back Pain and Disability Physical, run by University of Thessaly 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 4 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 18 Feb 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 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?
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?
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?
Pain intensity (time frame: From enrollment to the end of treatment at 3 weeks and after 6 months from the enrollment). 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 18 Feb 2026.