Fibromyalgia (FM)PNENCT07693998
Pain Neuroscience Education for Chronic Pain
A study testing Therapeutic Exercise and Education in Pain Neuroscience in people with Fibromyalgia (FM) and Chronic Low Back Pain (CLBP), run by University of Valencia at 1 site in Spain.
Trial summary
Chronic pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, with a high prevalence in Spain (25.9%) and an average duration of 6.83 years, highlighting its significant health and social impact. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia (FM), Chronic Low Back Pain (CLBP), Chronic Pain
- What is being tested?
- Therapeutic Exercise and Education in Pain Neuroscience
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 5 May 2026to 31 Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of fibromyalgia according to the 2010/2011 American College of -Rheumatology criteria
- Ability to understand and follow study instructions (Mini-Mental State Examination [MMSE] score >23)
- Chronic low back pain lasting at least 3 months
- Low back pain occurring on 3 or more days per week
- Pain located between the lower rib margin and the gluteal folds
- Ability to understand and follow study instructions (Mini-Mental State Examination [MMSE] score >23)
Who cannot join
- Changes in medication during the month prior to enrollment
- Disorders affecting the central or peripheral nervous system
- Chronic Low Back Pain (CLBP)
- Changes in medication during the month prior to enrollment
- Disorders affecting the central or peripheral nervous system
- History of spinal surgery
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: Effectiveness of Pain Neuroscience Education Combined With Therapeutic Exercise in People With Chronic Pain
Chronic pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, with a high prevalence in Spain (25.9%) and an average duration of 6.83 years, highlighting its significant health and social impact. Among its manifestations, chronic low back pain (CLBP) is the most common, affecting 58.1% of individuals with chronic pain, while fibromyalgia (FM) accounts for 10.4%. In both cases, a relevant proportion of patients do not present a clear organic cause, which complicates diagnosis and treatment and reflects the complexity of nonspecific chronic pain.
CLBP is associated with a high functional and occupational impact, being one of the main causes of temporary disability. FM, on the other hand, is characterized by widespread musculoskeletal pain accompanied by fatigue, sleep disturbances, and emotional symptoms, constituting a condition with systemic involvement. Both conditions can occur throughout the lifespan, with variations in prevalence depending on age, sex, social class, and the presence of comorbidities.
Read more
Aging introduces relevant differences in pain experience and treatment response. At the physiological level, changes occur in the musculoskeletal system, such as the progressive loss of muscle mass (especially type II fibers) and decreased bone mineral density, which increases the risk of sarcopenia and frailty. In contrast, young adults show greater anabolic capacity, better hypertrophic response, and higher neuromuscular efficiency, favoring faster adaptations to exercise. These differences justify the need to consider age as a key factor in the therapeutic approach.
In addition to structural changes, central sensitization plays a fundamental role in the chronification of pain. This process involves sustained hyperexcitability of the central nervous system, with a reduced pain threshold and altered inhibitory mechanisms, contributing to the persistence of pain even in the absence of significant tissue damage.
Therapeutic exercise (TE) is one of the main non-pharmacological interventions for chronic pain and has demonstrated effectiveness in reducing pain and improving functionality. However, its long-term effects are limited, largely due to adherence issues related to pain, as well as psychological, social, and educational factors. Educational level influences both the understanding of the intervention and adherence, generally being higher in young adults, which may affect treatment outcomes.
In this context, Pain Neuroscience Education (PNE) has emerged as a complementary strategy aimed at improving understanding of pain mechanisms and promoting adaptive behavioral changes. The combination of PNE and TE has shown positive effects in patients with CLBP and FM, especially in variables related to pain and psychosocial factors.
However, there is a lack of evidence regarding the impact of this combination on objective functional parameters, such as spinal movement during functional activities. Therefore, it is necessary to investigate the effectiveness of the combined intervention of PNE and TE not only on pain but also on biomechanical variables such as range, velocity, and quality of movement, using precise measurement instruments.
Read the detailed description
This study aims to evaluate the effectiveness of Pain Neuroscience Education (PNE) combined with Therapeutic Exercise (TE) in individuals with chronic low back pain (CLBP) and fibromyalgia (FM). Chronic pain conditions are frequently associated with maladaptive pain beliefs, pain catastrophizing, central sensitization, and functional limitations. PNE has been proposed as an educational approach to improve patients' understanding of pain mechanisms and promote adaptive coping strategies, potentially enhancing the effects of exercise-based interventions.
The study is designed as a randomized controlled clinical trial including participants with either CLBP or FM. Participants will be stratified according to age (<65 years and ≥65 years) and clinical condition (CLBP or FM) and then randomly assigned to one of two intervention groups: (1) PNE combined with TE, or (2) placebo education combined with the same TE program.
The intervention period will last eight weeks. All participants will perform a standardized therapeutic exercise program focused on physical function and movement. Participants allocated to the experimental group will additionally receive PNE sessions addressing contemporary pain neuroscience concepts, including pain mechanisms, central sensitization, the influence of psychosocial factors, fear of movement, and self-management strategies. Participants in the control group will receive placebo educational sessions focused on anatomy and biomechanics, matched for duration and attention.
Assessments will be conducted at baseline, immediately after the intervention, and during follow-up periods at 4, 12, and 24 weeks after treatment completion. The study will examine changes in pain-related, psychological, sensory, and functional outcomes over time and compare responses between clinical conditions and age groups.
The results of this study may contribute to understanding the added value of PNE when combined with therapeutic exercise and whether age and clinical diagnosis influence treatment response in individuals with chronic pain.
- Being tested
- Therapeutic Exercise and Education in Pain Neuroscience, Therapeutic exercise and education in the neuroscience of pain: the placebo effect
- Keywords
- chronic low back pain, therapeutic exercise, pain neuroscience education, fibromyalgia, chronic pain
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Exercise and Education in Pain NeuroscienceOther
For the experimental group, the intervention consists of an 8-week therapeutic exercise program combined with education on the neuroscience of pain, comprising 3 exercise sessions and 1 educational session per week.
Therapeutic exercise and education in the neuroscience of pain: the placebo effectOther
For the control group, the intervention consists of a therapeutic exercise program combined with placebo education, which introduces basic concepts of anatomy and biomechanics. The intervention lasts 8 weeks, with 3 exercise sessions and 1 education session per week.
| Study group | Role | What they receive |
|---|---|---|
| EG Fibromyalgia | Experimental | Fibromyalgia Intervention Group: Exercise and Pain Education Receives: Other: Therapeutic Exercise and Education in Pain Neuroscience |
| CG Fibromyalgia | Placebo comparator | Fibromyalgia Control Group: Exercise and Placebo Education Receives: Other: Therapeutic exercise and education in the neuroscience of pain: the placebo effect |
| EG Chronic Low Back Pain | Experimental | Experimental Group for Chronic Low Back Pain: Exercise and Pain Education Receives: Other: Therapeutic Exercise and Education in Pain Neuroscience |
| CG Chronic Low Back Pain | Placebo comparator | Experimental Group for Chronic Low Back Pain: Exercise and Placebo Education Receives: Other: Therapeutic exercise and education in the neuroscience of pain: the placebo effect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of physical activity
Using the International Physical Activity Questionnaire (IPAQ). Scores are expressed in MET-minutes/week. Higher scores indicate higher levels of physical activity and a better outcome.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Central level of awareness
Using the Central Sensitization Inventory (CSI). Total score ranges from 0 to 100. Higher scores indicate greater symptoms related to central sensitization and a worse outcome.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Pain on movement
Pain using the Visual Analogue Scale (VAS): Scores range from 0 to 10, with higher scores indicating greater pain intensity and a worse outcome.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Level of catastrophizing
Level of catastrophizing using the Pain Catastrophizing Scale (PCS). Total score ranges from 0 to 52. Higher scores indicate greater pain catastrophizing and a worse outcome.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Functionality - Lumbar movements
Using a motion capture system. Each movement is performed 5 times (the middle 3 repetitions will be analyzed). In all cases, pain will be assessed using a visual analog scale ranging from 0 to 10. Thirty-six markers will be placed throughout the body, except on the hands. The tests measured using the motion capture system will be: lumbar flexion-extension, rotations, and lateral bending.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Functionality - The 5 Time Sit to Stand Test
Using a motion capture system. Each movement is performed 5 times (the middle 3 repetitions will be analyzed). In all cases, pain will be assessed using a visual analog scale ranging from 0 to 10. Thirty-six markers will be placed throughout the body, except on the hands. The test measured using the motion capture system will be the 5-Time Sit-to-Stand Test. he outcome is the time required to complete five consecutive sit-to-stand repetitions, measured in seconds. Scores range from 0 seconds to no theoretical maximum. Higher scores indicate poorer lower-limb functional performance and a worse outcome.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Functionality - Lifting a 5 kg ball off the floor
Using a motion capture system. Each movement is performed 5 times (the middle 3 repetitions will be analyzed). In all cases, pain will be assessed using a visual analog scale ranging from 0 to 10. Thirty-six markers will be placed throughout the body, except on the hands. The test measured using the motion capture system will be lifting a 5 kg ball from the floor in a free-standing position, in a deadlift and in a squat.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Degree of disability
Using the Oswestry Disability Index (ODI): Scores range from 0 to 100%, with higher scores indicating greater disability and a worse outcome.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Conditioned Sensitivity Test
Test to assess the condition of the nervous system. The test stimulus is applied using an algometer, and the pressure pain threshold is assessed on the tibialis anterior muscle (5 cm distal to the tibial tuberosity). The patient verbally reports the point at which pressure becomes painful (the average of three consecutive measurements is calculated). Next, a conditioning stimulus is applied using a blood pressure cuff at a constant pressure of 240 mmHg for 120 seconds. Finally, the pressure pain threshold in the tibialis anterior is assessed.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Biering-Sörensen Test
This is a functional test of the lumbar spine used to measure the isometric strength and endurance of the trunk extensor muscles, particularly in the lumbar spine. This test is measured using surface electromyography (EMG), and the electrodes-which are 20 mm in size-should be placed on the iliocostalis muscle 3-4 cm lateral to the midline and at the level of L2-L4.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Secondary outcomes (8)
Anthropometric data - Weigth
Weight will be measured using a bioimpedance scale and will be reported in kilograms.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Demographic data - Age
Age. Age will be expressed in years.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Anthropometric data - Body Mass Index (BMI)
Body Mass Index. BMI will be measured using a bioimpedance scale and will be expressed as a percentage and in kg/m²
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Demographic data - Gender
Gender (male or female)
Measured: In the initial valuation.
Sensitivity
Using the Semmes-Weinstein monofilament test for tactile sensitivity and the pinprick test for pain sensitivity by dermatome.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Anxiety and depression
Using the Hospital Anxiety and Depression Scale (HADS). Total score ranges from 0 to 42. Higher scores indicate greater anxiety and depression symptoms and a worse outcome.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Kinesiophobia
Using the Fear-Avoidance Beliefs Questionnaire (FABQ). Total score ranges from 0 to 96. Higher scores indicate stronger fear-avoidance beliefs and a worse outcome.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Fibromyalgia Index
Using the Fibromyalgia Impact Questionnaire (FIQ).Total score ranges from 0 to 100. Higher scores indicate greater impact of fibromyalgia and a worse outcome.
Measured: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start5 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- The study design is a clinical intervention trial. The study will be divided into two substudies conducted in parallel, based on the participants' condition-chronic low back pain (CLBP) or fibromyalgia (FM)-and their age (under 65 years and over 65 years).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pilar Serra Añó, University of Valencia
- Investigators
- Sara Mollá, Casanova, Study director, Universitat de València
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693998
- Sponsor's protocol ID
- 2025-FIS-4161138
- Acronym
- PNE
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For data protection purposes.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pain Neuroscience Education Combined With Therapeutic Exercise in People With Chronic Pain
- ClinicalTrials.gov ID
- NCT07693998
- Acronym / sponsor ID
- PNE / 2025-FIS-4161138
- Keywords
- chronic low back pain, therapeutic exercise, pain neuroscience education, fibromyalgia, chronic pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Jul 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.
Chronic pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, with a high prevalence in Spain (25.9%) and an average duration of 6.83 years, highlighting its significant health and social impact. Among its manifestations, chronic low back pain (CLBP) is the most common, affecting 58.1% of individuals with chronic pain, while fibromyalgia (FM) accounts for 10.4%. In both cases, a relevant proportion of patients do not present a clear organic cause, which complicates diagnosis and treatment and reflects the complexity of nonspecific chronic pain.
CLBP is associated with a high functional and occupational impact, being one of the main causes of temporary disability. FM, on the other hand, is characterized by widespread musculoskeletal pain accompanied by fatigue, sleep disturbances, and emotional symptoms, constituting a condition with systemic involvement. Both conditions can occur throughout the lifespan, with variations in prevalence depending on age, sex, social class, and the presence of comorbidities.
Aging introduces relevant differences in pain experience and treatment response. At the physiological level, changes occur in the musculoskeletal system, such as the progressive loss of muscle mass (especially type II fibers) and decreased bone mineral density, which increases the risk of sarcopenia and frailty. In contrast, young adults show greater anabolic capacity, better hypertrophic response, and higher neuromuscular efficiency, favoring faster adaptations to exercise. These differences justify the need to consider age as a key factor in the therapeutic approach.
In addition to structural changes, central sensitization plays a fundamental role in the chronification of pain. This process involves sustained hyperexcitability of the central nervous system, with a reduced pain threshold and altered inhibitory mechanisms, contributing to the persistence of pain even in the absence of significant tissue damage.
Therapeutic exercise (TE) is one of the main non-pharmacological interventions for chronic pain and has demonstrated effectiveness in reducing pain and improving functionality. However, its long-term effects are limited, largely due to adherence issues related to pain, as well as psychological, social, and educational factors. Educational level influences both the understanding of the intervention and adherence, generally being higher in young adults, which may affect treatment outcomes.
In this context, Pain Neuroscience Education (PNE) has emerged as a complementary strategy aimed at improving understanding of pain mechanisms and promoting adaptive behavioral changes. The combination of PNE and TE has shown positive effects in patients with CLBP and FM, especially in variables related to pain and psychosocial factors.
However, there is a lack of evidence regarding the impact of this combination on objective functional parameters, such as spinal movement during functional activities. Therefore, it is necessary to investigate the effectiveness of the combined intervention of PNE and TE not only on pain but also on biomechanical variables such as range, velocity, and quality of movement, using precise measurement instruments.
Detailed description
This study aims to evaluate the effectiveness of Pain Neuroscience Education (PNE) combined with Therapeutic Exercise (TE) in individuals with chronic low back pain (CLBP) and fibromyalgia (FM). Chronic pain conditions are frequently associated with maladaptive pain beliefs, pain catastrophizing, central sensitization, and functional limitations. PNE has been proposed as an educational approach to improve patients' understanding of pain mechanisms and promote adaptive coping strategies, potentially enhancing the effects of exercise-based interventions.
The study is designed as a randomized controlled clinical trial including participants with either CLBP or FM. Participants will be stratified according to age (<65 years and ≥65 years) and clinical condition (CLBP or FM) and then randomly assigned to one of two intervention groups: (1) PNE combined with TE, or (2) placebo education combined with the same TE program.
The intervention period will last eight weeks. All participants will perform a standardized therapeutic exercise program focused on physical function and movement. Participants allocated to the experimental group will additionally receive PNE sessions addressing contemporary pain neuroscience concepts, including pain mechanisms, central sensitization, the influence of psychosocial factors, fear of movement, and self-management strategies. Participants in the control group will receive placebo educational sessions focused on anatomy and biomechanics, matched for duration and attention.
Assessments will be conducted at baseline, immediately after the intervention, and during follow-up periods at 4, 12, and 24 weeks after treatment completion. The study will examine changes in pain-related, psychological, sensory, and functional outcomes over time and compare responses between clinical conditions and age groups.
The results of this study may contribute to understanding the added value of PNE when combined with therapeutic exercise and whether age and clinical diagnosis influence treatment response in individuals with chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The study design is a clinical intervention trial. The study will be divided into two substudies conducted in parallel, based on the participants' condition-chronic low back pain (CLBP) or fibromyalgia (FM)-and their age (under 65 years and over 65 years).
| Arm | Type | Receives |
|---|---|---|
| EG Fibromyalgia | Experimental | Other: Therapeutic Exercise and Education in Pain NeuroscienceFibromyalgia Intervention Group: Exercise and Pain Education |
| CG Fibromyalgia | Placebo comparator | Other: Therapeutic exercise and education in the neuroscience of pain: the placebo effectFibromyalgia Control Group: Exercise and Placebo Education |
| EG Chronic Low Back Pain | Experimental | Other: Therapeutic Exercise and Education in Pain NeuroscienceExperimental Group for Chronic Low Back Pain: Exercise and Pain Education |
| CG Chronic Low Back Pain | Placebo comparator | Other: Therapeutic exercise and education in the neuroscience of pain: the placebo effectExperimental Group for Chronic Low Back Pain: Exercise and Placebo Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of fibromyalgia according to the 2010/2011 American College of -Rheumatology criteria
- Ability to understand and follow study instructions (Mini-Mental State Examination [MMSE] score >23)
- Chronic low back pain lasting at least 3 months
- Low back pain occurring on 3 or more days per week
- Pain located between the lower rib margin and the gluteal folds
Key exclusion criteria (6 listed)
- Changes in medication during the month prior to enrollment
- Disorders affecting the central or peripheral nervous system
- Chronic Low Back Pain (CLBP)
- Changes in medication during the month prior to enrollment
- Disorders affecting the central or peripheral nervous system
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 Exercise and Education in Pain NeuroscienceFor the experimental group, the intervention consists of an 8-week therapeutic exercise program combined with education on the neuroscience of pain, comprising 3 exercise sessions and 1 educational session per week. | Other | EG Chronic Low Back Pain, EG Fibromyalgia |
| Therapeutic exercise and education in the neuroscience of pain: the placebo effectFor the control group, the intervention consists of a therapeutic exercise program combined with placebo education, which introduces basic concepts of anatomy and biomechanics. The intervention lasts 8 weeks, with 3 exercise sessions and 1 education session per week. | Other | CG Chronic Low Back Pain, CG Fibromyalgia |
Primary outcome
Level of physical activity
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using the International Physical Activity Questionnaire (IPAQ). Scores are expressed in MET-minutes/week. Higher scores indicate higher levels of physical activity and a better outcome.
Central level of awareness
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using the Central Sensitization Inventory (CSI). Total score ranges from 0 to 100. Higher scores indicate greater symptoms related to central sensitization and a worse outcome.
Pain on movement
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Pain using the Visual Analogue Scale (VAS): Scores range from 0 to 10, with higher scores indicating greater pain intensity and a worse outcome.
Level of catastrophizing
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Level of catastrophizing using the Pain Catastrophizing Scale (PCS). Total score ranges from 0 to 52. Higher scores indicate greater pain catastrophizing and a worse outcome.
Functionality - Lumbar movements
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using a motion capture system. Each movement is performed 5 times (the middle 3 repetitions will be analyzed). In all cases, pain will be assessed using a visual analog scale ranging from 0 to 10. Thirty-six markers will be placed throughout the body, except on the hands. The tests measured using the motion capture system will be: lumbar flexion-extension, rotations, and lateral bending.
Functionality - The 5 Time Sit to Stand Test
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using a motion capture system. Each movement is performed 5 times (the middle 3 repetitions will be analyzed). In all cases, pain will be assessed using a visual analog scale ranging from 0 to 10. Thirty-six markers will be placed throughout the body, except on the hands. The test measured using the motion capture system will be the 5-Time Sit-to-Stand Test. he outcome is the time required to complete five consecutive sit-to-stand repetitions, measured in seconds. Scores range from 0 seconds to no theoretical maximum. Higher scores indicate poorer lower-limb functional performance and a worse outcome.
Functionality - Lifting a 5 kg ball off the floor
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using a motion capture system. Each movement is performed 5 times (the middle 3 repetitions will be analyzed). In all cases, pain will be assessed using a visual analog scale ranging from 0 to 10. Thirty-six markers will be placed throughout the body, except on the hands. The test measured using the motion capture system will be lifting a 5 kg ball from the floor in a free-standing position, in a deadlift and in a squat.
Degree of disability
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using the Oswestry Disability Index (ODI): Scores range from 0 to 100%, with higher scores indicating greater disability and a worse outcome.
Conditioned Sensitivity Test
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Test to assess the condition of the nervous system. The test stimulus is applied using an algometer, and the pressure pain threshold is assessed on the tibialis anterior muscle (5 cm distal to the tibial tuberosity). The patient verbally reports the point at which pressure becomes painful (the average of three consecutive measurements is calculated). Next, a conditioning stimulus is applied using a blood pressure cuff at a constant pressure of 240 mmHg for 120 seconds. Finally, the pressure pain threshold in the tibialis anterior is assessed.
Biering-Sörensen Test
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
This is a functional test of the lumbar spine used to measure the isometric strength and endurance of the trunk extensor muscles, particularly in the lumbar spine. This test is measured using surface electromyography (EMG), and the electrodes-which are 20 mm in size-should be placed on the iliocostalis muscle 3-4 cm lateral to the midline and at the level of L2-L4.
8 secondary outcomes
Anthropometric data - Weigth
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Demographic data - Age
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Anthropometric data - Body Mass Index (BMI)
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Demographic data - Gender
Time frame: In the initial valuation.
Sensitivity
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Anxiety and depression
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Kinesiophobia
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Fibromyalgia Index
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
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 9 Jul 2026.
- Individual participant dataSharing planned: No. For data protection purposes.
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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.
Sara Mollá, Casanova study director
Universitat de València
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 Education in Pain Neuroscience in people with Fibromyalgia (FM) and Chronic Low Back Pain (CLBP), run by University of Valencia at 1 site in Spain.
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 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 9 Jul 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Level of physical activity (time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.). The study lists 10 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 9 Jul 2026.