Chronic Low-back Pain (cLBP)NCT07856992
Therapeutic Exercise Plus Pain Neuroscience Education for Chronic Low Back Pain
A study testing Therapeutic exercise and Pain Neuroscience Education in people with Chronic Low-back Pain (cLBP), run by Qingdao Municipal Hospital at 1 site in China.
Trial summary
### What is this study about? This study looked at whether adding pain neuroscience education (PNE) to standard therapeutic exercise helps people with chronic low back pain who are afraid of moving (a condition called *kinesiophobia*). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- What is being tested?
- Therapeutic exercise and Pain Neuroscience Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2025to 15 Oct 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- Chronic non-specific low back pain (CLBP) lasting ≥3 months
- Numerical Rating Scale (NRS) score ≥3
- Tampa Scale for Kinesiophobia (TSK-17) score ≥37
- Right-handed
- Able to complete all clinical and magnetic resonance imaging (MRI) assessments
Who cannot join
- Specific low back pain caused by tumor, infection, fracture, or inflammatory disease
- Previous lumbar surgery
- Severe neurological or psychiatric disorders
- Contraindications to MRI
- Participation in other structured rehabilitation programs during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjunct Pain Neuroscience Education for Kinesiophobia in Chronic Low Back Pain: a Randomized Controlled Trial With Exploratory Resting-state fMRI
### What is this study about?
This study looked at whether adding pain neuroscience education (PNE) to standard therapeutic exercise helps people with chronic low back pain who are afraid of moving (a condition called *kinesiophobia*).
Read more
### Why does it matter?
Chronic low back pain is the leading cause of disability worldwide. Many people with chronic back pain develop fear of movement, which makes them avoid exercise and can slow down recovery. While exercise is the recommended first-line treatment, fear of movement often reduces how much patients benefit from it.
Pain neuroscience education is a talking therapy that helps patients understand that chronic pain is not always a sign of tissue damage - it often involves the nervous system becoming overly sensitive. The idea is that changing how patients think about pain may reduce their fear and help them engage more fully in exercise.
### What did the researchers do?
Patients with chronic low back pain and high fear of movement were randomly assigned to two groups
- Group 1: 8 weeks of therapeutic exercise alone
- Group 2: 8 weeks of therapeutic exercise plus two pain neuroscience education sessions (at the start and at week 4)
- Patients were assessed at baseline, 8 weeks, and 24 weeks (6-month follow-up)
- Measures included: fear of movement (TSK-17), pain intensity (NRS), disability (RMDQ), pain catastrophizing (PCS), and central sensitization symptoms (CSI)
- Brain scans (resting-state fMRI) were taken before and after the intervention to explore potential brain-behavior links
- Conditions
- Chronic Low-back Pain (cLBP)
- Being tested
- Therapeutic exercise, Pain Neuroscience Education
- Keywords
- chronic low back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exerciseBehavioural
Therapeutic Exercise (TE) is a structured, supervised program of physical activities designed to improve strength, flexibility, motor control, and functional capacity in patients with musculoskeletal conditions such as chronic low back pain. In this study, the TE program combined three components: motor control exercises (e.g., transversus abdominis and multifidus activation to stabilize the lumbar spine), stretching exercises (e.g., piriformis and erector spinae stretches), and low-intensity aerobic training (daily walking). It was delivered in two supervised face-to-face sessions (at baseline and week 4) with prescribed home exercises performed twice daily, and served as the active control condition that both study groups received-with the experimental group additionally receiving pain neuroscience education.
Pain Neuroscience EducationBehavioural
Pain Neuroscience Education (PNE) is a non-pharmacological, educational intervention that helps people with chronic pain reconceptualize their understanding of pain. Through structured discussions and visual materials, a trained therapist explains that chronic pain is often not a reliable sign of ongoing tissue damage but rather a result of heightened nervous system sensitivity, and that psychological factors such as fear, stress, and negative beliefs can amplify pain perception. The goal is to correct misconceptions about pain, reduce fear of movement (kinesiophobia), and encourage patients to engage more fully in exercise and rehabilitation-rather than directly treating pain through manual therapy, medication, or exercise itself.
| Study group | Role | What they receive |
|---|---|---|
| pain neuroscience education plus therapeutic exercise (PNE+TE) group | Experimental | Not described Receives: Behavioral: Therapeutic exercise; Behavioral: Pain Neuroscience Education |
| therapeutic exercise (TE) group | Active comparator | Not described Receives: Behavioral: Therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
TSK-17
TSK-17, full name Tampa Scale of Kinesiophobia-17, ranges from 17 to 68, and a higher score indicates worse kinesiophobia.
Measured: TSK-17 was administered at baseline, 8 weeks, 24 weeks.
Secondary outcomes (6)
Numerical Rating Scale
NRS, full name Numeric Rating Scale, ranges from 0 to 10, and a higher score indicates greater pain intensity.
Measured: at baseline, 8 weeks, 24 weeks
Roland-Morris Disability Questionnaire
RMDQ, full name Roland-Morris Disability Questionnaire, ranges from 0 to 24, and a higher score indicates more severe low back pain-related disability.
Measured: at baseline, 8 weeks, 24 weeks
Pain Catastrophizing Scale
PCS, full name Pain Catastrophizing Scale, ranges from 0 to 52, and a higher score indicates stronger pain catastrophizing.
Measured: at baseline, 8 weeks, 24 weeks
Central Sensitization Inventory
CSI, full name Central Sensitization Inventory, ranges from 0 to 100, and a higher score indicates more prominent central sensitization symptoms.
Measured: at baseline, 8 weeks, 24 weeks
Fractional amplitude of low-frequency fluctuations
Measured: at baseline, 8 weeks
regional homogeneity (ReHo)
Measured: at baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start6 Jan 2025
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back Pain (cLBP)Studies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qingdao Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zichao Zhang, Qingdao Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856992
- Sponsor's protocol ID
- 2025-KY-125*129
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunct Pain Neuroscience Education for Kinesiophobia in Chronic Low Back Pain: a Randomized Controlled Trial With Exploratory Resting-state fMRI
- ClinicalTrials.gov ID
- NCT07856992
- Acronym / sponsor ID
- 2025-KY-125*129
- Conditions
- Chronic Low-back Pain (cLBP)
- Keywords
- chronic low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Qingdao Municipal HospitalUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 5 Oct 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.
### What is this study about?
This study looked at whether adding pain neuroscience education (PNE) to standard therapeutic exercise helps people with chronic low back pain who are afraid of moving (a condition called *kinesiophobia*).
### Why does it matter?
Chronic low back pain is the leading cause of disability worldwide. Many people with chronic back pain develop fear of movement, which makes them avoid exercise and can slow down recovery. While exercise is the recommended first-line treatment, fear of movement often reduces how much patients benefit from it.
Pain neuroscience education is a talking therapy that helps patients understand that chronic pain is not always a sign of tissue damage - it often involves the nervous system becoming overly sensitive. The idea is that changing how patients think about pain may reduce their fear and help them engage more fully in exercise.
### What did the researchers do?
Patients with chronic low back pain and high fear of movement were randomly assigned to two groups
- Group 1: 8 weeks of therapeutic exercise alone
- Group 2: 8 weeks of therapeutic exercise plus two pain neuroscience education sessions (at the start and at week 4)
- Patients were assessed at baseline, 8 weeks, and 24 weeks (6-month follow-up)
- Measures included: fear of movement (TSK-17), pain intensity (NRS), disability (RMDQ), pain catastrophizing (PCS), and central sensitization symptoms (CSI)
- Brain scans (resting-state fMRI) were taken before and after the intervention to explore potential brain-behavior links
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pain neuroscience education plus therapeutic exercise (PNE+TE) group | Experimental | Behavioral: Therapeutic exercise, Behavioral: Pain Neuroscience Education |
| therapeutic exercise (TE) group | Active comparator | Behavioral: Therapeutic exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-65 years
- Chronic non-specific low back pain (CLBP) lasting ≥3 months
- Numerical Rating Scale (NRS) score ≥3
- Tampa Scale for Kinesiophobia (TSK-17) score ≥37
- Right-handed
Key exclusion criteria (5 listed)
- Specific low back pain caused by tumor, infection, fracture, or inflammatory disease
- Previous lumbar surgery
- Severe neurological or psychiatric disorders
- Contraindications to MRI
- Participation in other structured rehabilitation programs during the study period
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 |
|---|---|---|
| Therapeutic exerciseTherapeutic Exercise (TE) is a structured, supervised program of physical activities designed to improve strength, flexibility, motor control, and functional capacity in patients with musculoskeletal conditions such as chronic low back pain. In this study, the TE program combined three components: motor control exercises (e.g., transversus abdominis and multifidus activation to stabilize the lumbar spine), stretching exercises (e.g., piriformis and erector spinae stretches), and low-intensity aerobic training (daily walking). It was delivered in two supervised face-to-face sessions (at baseline and week 4) with prescribed home exercises performed twice daily, and served as the active control condition that both study groups received-with the experimental group additionally receiving pain neuroscience education. | Behavioural | pain neuroscience education plus therapeutic exercise (PNE+TE) group, therapeutic exercise (TE) group |
| Pain Neuroscience EducationPain Neuroscience Education (PNE) is a non-pharmacological, educational intervention that helps people with chronic pain reconceptualize their understanding of pain. Through structured discussions and visual materials, a trained therapist explains that chronic pain is often not a reliable sign of ongoing tissue damage but rather a result of heightened nervous system sensitivity, and that psychological factors such as fear, stress, and negative beliefs can amplify pain perception. The goal is to correct misconceptions about pain, reduce fear of movement (kinesiophobia), and encourage patients to engage more fully in exercise and rehabilitation-rather than directly treating pain through manual therapy, medication, or exercise itself. | Behavioural | pain neuroscience education plus therapeutic exercise (PNE+TE) group |
Primary outcome
TSK-17
Time frame: TSK-17 was administered at baseline, 8 weeks, 24 weeks.
TSK-17, full name Tampa Scale of Kinesiophobia-17, ranges from 17 to 68, and a higher score indicates worse kinesiophobia.
6 secondary outcomes
Numerical Rating Scale
Time frame: at baseline, 8 weeks, 24 weeks
Roland-Morris Disability Questionnaire
Time frame: at baseline, 8 weeks, 24 weeks
Pain Catastrophizing Scale
Time frame: at baseline, 8 weeks, 24 weeks
Central Sensitization Inventory
Time frame: at baseline, 8 weeks, 24 weeks
Fractional amplitude of low-frequency fluctuations
Time frame: at baseline, 8 weeks
regional homogeneity (ReHo)
Time frame: at baseline, 8 weeks
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 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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 Therapeutic exercise and Pain Neuroscience Education in people with Chronic Low-back Pain (cLBP), run by Qingdao Municipal Hospital at 1 site in China.
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 6 inclusion and 5 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 5 Oct 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 China. 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?
TSK-17 (time frame: TSK-17 was administered at baseline, 8 weeks, 24 weeks.). 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 5 Oct 2026.