Chronic Musculoskeletal PainNCT07299929
Multimodal Physiotherapy and Pain Coping in Primary Care
A study testing Multimodal Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic Exercise in people with Chronic Musculoskeletal Pain, run by Universitat Jaume I.
Trial summary
This quasi-experimental, multicenter study aims to evaluate the effectiveness of a multimodal physiotherapy intervention-based on pain neuroscience education and therapeutic exercise-on health-related quality of life in patients with persistent musculoskeletal pain treated in Primary Care. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- Multimodal Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2027
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent nonspecific musculoskeletal pain lasting at least 6 months
Who cannot join
- Oncologic pain.
- Spinal fracture or surgical intervention within the 12 months prior to the intervention.
- Cognitive impairment that prevents comprehension of the intervention content (in case of doubt, the Mini-Mental State Examination will be administered, requiring a minimum score of 25).
- Physical performance deficit that prevents execution of the intervention (minimum requirement: completion of the Timed Up and Go test within the normal time of 10 seconds).
- Pregnancy.
- Cauda equina syndrome.
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- Presence of urinary and/or fecal incontinence.
- Severe psychiatric disorders.
- Autoimmune diseases.
- Associated medical conditions that preclude participation in a physical exercise program (e.g., myopathies, neurological diseases with significant functional impairment).
- Patients undergoing alternative therapies.
- Patients with an implanted neurostimulator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multimodal Physiotherapy Intervention for Active Coping With Persistent Musculoskeletal Pain in Primary Care
This quasi-experimental, multicenter study aims to evaluate the effectiveness of a multimodal physiotherapy intervention-based on pain neuroscience education and therapeutic exercise-on health-related quality of life in patients with persistent musculoskeletal pain treated in Primary Care.
The study will be conducted in four Primary Care physiotherapy units in the Valencian Community (Spain). A total of at least 68 participants aged 18 to 70 years with nonspecific persistent musculoskeletal pain lasting at least six months will be recruited.
Read more
The intervention will consist of a structured multimodal physiotherapy program including educational sessions on pain neuroscience and guided therapeutic exercise. The main outcome will be health-related quality of life, assessed using the SF-36 Health Survey. Secondary outcomes will include pain catastrophizing (Pain Catastrophizing Scale), kinesiophobia (Tampa Scale for Kinesiophobia), and central sensitization (Central Sensitization Inventory), among others.
Data will be collected using the REDCap electronic platform at three time points: baseline (pre-intervention), immediately after the intervention, and six months post-intervention. Statistical analysis will include descriptive statistics, bivariate analyses, and paired comparisons to assess changes over time.
The study seeks to generate evidence on the feasibility and potential effectiveness of implementing a multimodal physiotherapy intervention for active coping with chronic musculoskeletal pain in the context of Primary Care.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- Multimodal Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic ExerciseBehavioural
The intervention consists of a multimodal physiotherapy program designed to promote active coping and improve health-related quality of life in patients with persistent musculoskeletal pain. It includes educational sessions on pain neuroscience aimed at reconceptualizing pain and reducing maladaptive beliefs, combined with supervised therapeutic exercise focused on mobility, strength, and functional recovery. The program will be delivered in small group sessions by trained physiotherapists in Primary Care settings over several weeks. Participants will be encouraged to progressively integrate the exercises and concepts into their daily activities to foster self-management and long-term adherence.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Physiotherapy Intervention | Experimental | Participants will receive a multimodal physiotherapy intervention designed to improve active coping and health-related quality of life in individuals with persistent musculoskeletal pain. The program combines pain neuroscience education sessions with guided therapeutic exercise, delivered by physiotherapists in Primary Care settings. The intervention will be conducted in group sessions over several weeks and will include education on pain mechanisms, movement retraining, and individualized exercise progression. Receives: Behavioral: Multimodal Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life Measured With the 36-Item Short Form Health Survey (SF-36)
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The instrument provides eight domain scores and a total score, each ranging from 0 to 100. Higher scores indicate better perceived health-related quality of life.
Measured: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.
Secondary outcomes (6)
Pain Catastrophizing Measured With the Pain Catastrophizing Scale (PCS)
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), a 13-item questionnaire evaluating rumination, magnification, and helplessness related to pain. Total scores range from 0 to 52, with higher scores indicating greater pain catastrophizing.
Measured: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.
Kinesiophobia Assessed Using the Tampa Scale for Kinesiophobia (TSK-11 or TSK-17)
Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK), a validated questionnaire measuring fear of movement and reinjury. Higher scores indicate greater kinesiophobia.
Measured: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.
Central Sensitization Assessed With the Central Sensitization Inventory (CSI)
Central sensitization will be assessed using the Central Sensitization Inventory (CSI), a 25-item questionnaire evaluating symptoms associated with central sensitivity syndromes. Scores range from 0 to 100, with higher scores indicating greater central sensitization.
Measured: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.
Pain Intensity Measured Using the Numerical Rating Scale (NRS 0-10)
Pain intensity will be measured using the 11-point Numerical Rating Scale (NRS), where participants rate their average pain during the previous week from 0 ("no pain") to 10 ("worst imaginable pain"). Higher scores indicate greater pain intensity.
Measured: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.
Treatment Adherence Assessed With a Session Attendance Log
Treatment adherence will be assessed by recording the number of intervention sessions attended by each participant, expressed as the percentage of sessions completed relative to the total scheduled.
Measured: During the intervention period
Patient Satisfaction Measured With a Likert-Type Satisfaction Questionnaire
Patient satisfaction with the intervention will be assessed using a Likert-type questionnaire (e.g., 0-10 scale or 5-point scale). Higher scores indicate greater satisfaction.
Measured: Immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study startSep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Ortiz Mallasen, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299929
- Sponsor's protocol ID
- DC-GVA-2025
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- 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 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Physiotherapy Intervention for Active Coping With Persistent Musculoskeletal Pain in Primary Care
- ClinicalTrials.gov ID
- NCT07299929
- Acronym / sponsor ID
- DC-GVA-2025
- Conditions
- Chronic Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 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.
This quasi-experimental, multicenter study aims to evaluate the effectiveness of a multimodal physiotherapy intervention-based on pain neuroscience education and therapeutic exercise-on health-related quality of life in patients with persistent musculoskeletal pain treated in Primary Care.
The study will be conducted in four Primary Care physiotherapy units in the Valencian Community (Spain). A total of at least 68 participants aged 18 to 70 years with nonspecific persistent musculoskeletal pain lasting at least six months will be recruited.
The intervention will consist of a structured multimodal physiotherapy program including educational sessions on pain neuroscience and guided therapeutic exercise. The main outcome will be health-related quality of life, assessed using the SF-36 Health Survey. Secondary outcomes will include pain catastrophizing (Pain Catastrophizing Scale), kinesiophobia (Tampa Scale for Kinesiophobia), and central sensitization (Central Sensitization Inventory), among others.
Data will be collected using the REDCap electronic platform at three time points: baseline (pre-intervention), immediately after the intervention, and six months post-intervention. Statistical analysis will include descriptive statistics, bivariate analyses, and paired comparisons to assess changes over time.
The study seeks to generate evidence on the feasibility and potential effectiveness of implementing a multimodal physiotherapy intervention for active coping with chronic musculoskeletal pain in the context of Primary Care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal Physiotherapy Intervention | Experimental | Behavioral: Multimodal Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic ExerciseParticipants will receive a multimodal physiotherapy intervention designed to improve active coping and health-related quality of life in individuals with persistent musculoskeletal pain. The program combines pain neuroscience education sessions with guided therapeutic exercise, delivered by physiotherapists in Primary Care settings. The intervention will be conducted in group sessions over several weeks and will include education on pain mechanisms, movement retraining, and individualized exercise progression. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Persistent nonspecific musculoskeletal pain lasting at least 6 months
Key exclusion criteria (12 listed)
- Oncologic pain.
- Spinal fracture or surgical intervention within the 12 months prior to the intervention.
- Cognitive impairment that prevents comprehension of the intervention content (in case of doubt, the Mini-Mental State Examination will be administered, requiring a minimum score of 25).
- Physical performance deficit that prevents execution of the intervention (minimum requirement: completion of the Timed Up and Go test within the normal time of 10 seconds).
- Pregnancy.
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 |
|---|---|---|
| Multimodal Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic ExerciseThe intervention consists of a multimodal physiotherapy program designed to promote active coping and improve health-related quality of life in patients with persistent musculoskeletal pain. It includes educational sessions on pain neuroscience aimed at reconceptualizing pain and reducing maladaptive beliefs, combined with supervised therapeutic exercise focused on mobility, strength, and functional recovery. The program will be delivered in small group sessions by trained physiotherapists in Primary Care settings over several weeks. Participants will be encouraged to progressively integrate the exercises and concepts into their daily activities to foster self-management and long-term adherence. | Behavioural | Multimodal Physiotherapy Intervention |
Primary outcome
Health-Related Quality of Life Measured With the 36-Item Short Form Health Survey (SF-36)
Time frame: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The instrument provides eight domain scores and a total score, each ranging from 0 to 100. Higher scores indicate better perceived health-related quality of life.
6 secondary outcomes
Pain Catastrophizing Measured With the Pain Catastrophizing Scale (PCS)
Time frame: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.
Kinesiophobia Assessed Using the Tampa Scale for Kinesiophobia (TSK-11 or TSK-17)
Time frame: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.
Central Sensitization Assessed With the Central Sensitization Inventory (CSI)
Time frame: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.
Pain Intensity Measured Using the Numerical Rating Scale (NRS 0-10)
Time frame: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.
Treatment Adherence Assessed With a Session Attendance Log
Time frame: During the intervention period
Patient Satisfaction Measured With a Likert-Type Satisfaction Questionnaire
Time frame: Immediately after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic Exercise in people with Chronic Musculoskeletal Pain, run by Universitat Jaume I.
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 1 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: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor Ortiz-Mallasen (34964387810, ortizv@uji.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life Measured With the 36-Item Short Form Health Survey (SF-36) (time frame: Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.