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Chronic Musculoskeletal PainDolorAPNCT07461298

Multimodal Intervention for Persistent Musculoskeletal Pain in Primary Care

A study testing Multimodal Pain Management Program and Usual Primary Care in people with Chronic Musculoskeletal Pain, run by Universitat Jaume I at 5 sites in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This multicenter randomized controlled trial aims to evaluate the effectiveness of a multimodal intervention for the active management of persistent musculoskeletal pain 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 Pain Management Program and Usual Primary Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
5 sitesSpain
Study dates
Jun 2026to Jan 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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged between 18 and 70 years
  • Diagnosis of nonspecific persistent musculoskeletal pain lasting at least 6 months
  • Receiving care in participating primary care centers
  • Ability to understand study procedures and provide written informed consent
  • Ability to complete self-administered questionnaires

Who cannot join

  • Specific musculoskeletal pathology requiring specialized treatment (e.g., fracture, inflammatory rheumatic disease, malignancy)
  • Neurological disorders affecting movement or pain perception
  • Severe psychiatric disorders that may interfere with participation
  • Participation in another structured pain management program during the study period
  • Cognitive impairment preventing questionnaire completion
  • Pregnancy (if considered clinically relevant)

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Victor Ortiz Mallasen contact

34964387810

ortizv@uji.es

5 sites in 1 country

Spain5 sites
  • Centro de Salud de Alginet

    Alginet, Valencia

    Rosa Navarro Catalá, navarro_roscat@gva.es

  • Centro de Salud de Benifaió

    Benifaió, Valencia

    Mª José Llácer Bosch, llacer_marbos@gva.es

  • Centro de Salud Marina Española

    Elda, Alicante

    Cristina Cuadrado Baca, cuadrado_cri@gva.es

  • Centro de Salud Integrado de la Vall d'Uixó

    Vall d'Uixó, Castellón

    Marta Masiá Ramos, masia_marram@gva.es

  • Centro de Salud de Villena I

    Villena, Alicante

    Mª Rosario Mondéjar Martín, mondejar_mro@gva.es

Other trials in Spain

About this study

Official title: Effectiveness of a Multimodal Intervention Based on Pain Neuroscience Education, Therapeutic Exercise and Healthy Lifestyle Promotion in Patients With Persistent Musculoskeletal Pain in Primary Care: A Multicenter Randomized Controlled Trial

This multicenter randomized controlled trial aims to evaluate the effectiveness of a multimodal intervention for the active management of persistent musculoskeletal pain in primary care. The intervention combines pain neuroscience education, therapeutic exercise, and the promotion of self-care and healthy lifestyle habits to improve health-related quality of life in adults with persistent nonspecific musculoskeletal pain lasting at least six months.

A total of 146 participants aged 18 to 70 years will be recruited from five primary care centers in the Comunitat Valenciana (Spain) and randomly assigned to either the experimental group or the control group. The primary outcome is health-related quality of life measured using the SF-36 Health Survey. Secondary outcomes include pain intensity, pain catastrophizing, kinesiophobia, central sensitization, emotional symptoms, perceived social support, medication use, and lifestyle-related variables. Assessments will be conducted at baseline, post-intervention, 6 months, and 12 months follow-up.

Read the detailed description

Persistent musculoskeletal pain represents a major public health problem and is one of the most frequent reasons for consultation in primary care. It is associated with reduced quality of life, functional limitations, emotional distress, increased healthcare utilization, and high socioeconomic costs. Contemporary pain science recognizes that persistent pain is a multidimensional experience involving biological, psychological, and social mechanisms, including central sensitization and maladaptive cognitive-emotional processes such as catastrophizing and fear-avoidance behaviors.

Current clinical practice guidelines recommend multimodal and non-pharmacological approaches as first-line management strategies. Pain neuroscience education (PNE) aims to reconceptualize pain by explaining the neurobiological and psychosocial mechanisms involved in persistent pain, thereby reducing perceived threat and maladaptive beliefs. Therapeutic exercise contributes to functional improvement, modulation of central pain mechanisms, and psychological well-being. Additionally, the promotion of self-care strategies and healthy lifestyle habits (including physical activity, sleep hygiene, stress management, and nutritional counseling) may enhance long-term outcomes and patient empowerment.

This study is a multicenter, parallel-group, single-blind randomized controlled trial conducted in five primary care centers in the Comunitat Valenciana (Spain). A total of 146 adults aged 18 to 70 years with nonspecific persistent musculoskeletal pain lasting at least six months will be recruited and randomly allocated to either an experimental group receiving the multimodal intervention or a control group receiving usual care.

The multimodal intervention integrates structured group-based pain neuroscience education sessions, supervised therapeutic exercise, and guidance on self-care and healthy lifestyle habits. The control group will continue to receive standard primary care management.

The primary outcome is health-related quality of life assessed using the SF-36 Health Survey. Secondary outcomes include pain intensity, number of painful areas, pain catastrophizing, kinesiophobia, central sensitization, emotional symptoms, perceived social support, medication consumption, and lifestyle-related variables. Data will be collected at baseline, immediately post-intervention, and at 6- and 12-month follow-ups using the REDCap electronic data capture system.

Statistical analyses will include descriptive statistics and inferential analyses to compare within- and between-group differences over time. The study aims to provide robust evidence regarding the effectiveness of a multimodal, biopsychosocial intervention delivered in primary care for the management of persistent musculoskeletal pain.

Being tested
Multimodal Pain Management Program, Usual Primary Care
Keywords
Physical exercise, Patient Care Group, Primary Health Care, Multimodal Intervention, Health-Related Quality of Life, Self-Management, Pain Neuroscience Education
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimodal Pain Management ProgramBehavioural

    The multimodal program combines pain neuroscience education, therapeutic exercise, and the promotion of self-care and healthy lifestyle habits. Pain neuroscience education focuses on reconceptualizing pain based on contemporary neurophysiological principles. Therapeutic exercise includes supervised physical activity aimed at improving strength, mobility, and functional capacity. The self-care component addresses lifestyle factors such as physical activity, sleep hygiene, stress management, and healthy nutrition.

  • Usual Primary CareOther

    Participants in the control group will continue receiving standard primary care treatment as determined by their healthcare providers. This may include medication, medical advice, or referral to other services according to routine clinical practice.

Study groups in NCT07461298
Study groupRoleWhat they receive
Multimodal Intervention GroupExperimentalParticipants assigned to the experimental group will receive a structured multimodal intervention delivered in primary care settings. The intervention integrates group-based pain neuroscience education sessions, supervised therapeutic exercise, and guidance on self-care strategies and healthy lifestyle habits. The program aims to promote active coping, improve functional capacity, and enhance health-related quality of life in individuals with persistent musculoskeletal pain.
Receives: Behavioral: Multimodal Pain Management Program
Usual Care GroupActive comparatorParticipants assigned to the control group will receive usual primary care management for persistent musculoskeletal pain. Usual care may include pharmacological treatment, medical follow-up, and referral to other healthcare services when considered necessary, according to standard clinical practice.
Receives: Other: Usual Primary Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health-Related Quality of Life

    Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). The SF-36 measures eight health domains and provides physical and mental component summary scores. Higher scores indicate better health-related quality of life.

    Measured: Baseline, immediately post-intervention, 6 months, and 12 months after intervention

Secondary outcomes (10)
  1. Pain Intensity

    Pain intensity measured using a numerical rating scale (NRS), where higher scores indicate greater pain intensity.

    Measured: Baseline, immediately post-intervention, 6 months, and 12 months after intervention

  2. Number of Painful Body Areas

    Number of body areas with reported pain as self-identified by participants.

    Measured: Baseline, immediately post-intervention, 6 months, and 12 months after intervention

  3. Pain Catastrophizing

    Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS). Higher scores indicate greater catastrophizing.

    Measured: Baseline, immediately post-intervention, 6 months, and 12 months after intervention

  4. Kinesiophobia

    Fear of movement assessed using the Tampa Scale of Kinesiophobia (TSK). Higher scores indicate greater fear of movement.

    Measured: Baseline, immediately post-intervention, 6 months, and 12 months after intervention

  5. Central Sensitization

    Central sensitization symptoms assessed using the Central Sensitization Inventory (CSI). Higher scores indicate greater symptom severity.

    Measured: Baseline, immediately post-intervention, 6 months, and 12 months after intervention

  6. Anxiety Symptoms

    Anxiety symptoms assessed using the Overall Anxiety Severity and Impairment Scale (OASIS). The OASIS is a 5-item self-report questionnaire measuring the frequency and severity of anxiety symptoms and related functional impairment. Scores range from 0 to 20, with higher scores indicating greater anxiety severity.

    Measured: Baseline, immediately post-intervention, 6 months, and 12 months after intervention

  7. Depressive Symptoms

    Depressive symptoms assessed using the Overall Depression Severity and Impairment Scale (ODSIS). The ODSIS is a 5-item self-report questionnaire assessing the frequency and severity of depressive symptoms and associated impairment. Scores range from 0 to 20, with higher scores indicating greater depressive symptom severity.

    Measured: Baseline, immediately post-intervention, 6 months, and 12 months after intervention

  8. Perceived Social Support

    Perceived social support assessed using the Duke-UNC Functional Social Support Questionnaire (DUKE-UNC-11). The questionnaire evaluates perceived emotional and instrumental social support. Scores range from 11 to 55, with higher scores indicating greater perceived social support.

    Measured: Baseline, immediately post-intervention, 6 months, and 12 months after intervention

  9. Medication Consumption

    Changes in the number and type of medications used for pain management.

    Measured: Baseline, immediately post-intervention, 6 months, and 12 months after intervention

  10. Participant Satisfaction With the Intervention

    Participant satisfaction assessed using the Client Satisfaction Questionnaire-8 (CSQ-8), an 8-item self-report instrument measuring satisfaction with healthcare services. Total scores range from 8 to 32, with higher scores indicating greater satisfaction with the intervention.

    Measured: Immediately post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

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
Participants will be randomly assigned in a 1:1 ratio to either the experimental group receiving the multimodal intervention or the control group receiving usual primary care. The two groups will be followed in parallel throughout the study period, with outcome assessments conducted at baseline, post-intervention, and at 6- and 12-month follow-ups.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07461298
Sponsor's protocol ID
UJI-DMP-AP-2026
Other IDs
OSF-ptwfy
Acronym
DolorAP
Status last verified
Mar 2026
First submitted
26 Feb 2026
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) underlying the results reported in publications will be made available upon reasonable request. Data will be shared after publication of the primary results and will include variables necessary to reproduce the analyses. All shared data will be fully anonymized in accordance with applicable data protection regulations (including GDPR). Requests must include a methodologically sound research proposal and will require approval by the principal investigator and the corresponding ethics committee where applicable.

Publications

  • Malfliet A, Kregel J, Coppieters I, De Pauw R, Meeus M, Roussel N, Cagnie B, Danneels L, Nijs J. Effect of Pain Neuroscience Education Combined With Cognition-Targeted Motor Control Training on Chronic Spinal Pain: A Randomized Clinical Trial. JAMA Neurol. 2018 Jul 1;75(7):808-817. doi: 10.1001/jamaneurol.2018.0492.

    PubMed 29710099
  • Geneen LJ, Moore RA, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2017 Jan 14;1(1):CD011279. doi: 10.1002/14651858.CD011279.pub2.

    PubMed 28087891
  • Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.

    PubMed 27351541
  • Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.

    PubMed 28192789

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal Pain Management Program and Usual Primary Care in people with Chronic Musculoskeletal Pain, run by Universitat Jaume I at 5 sites 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 5 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: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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. 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 (time frame: Baseline, immediately post-intervention, 6 months, and 12 months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07461298, which also lists 4 linked publications.

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 10 Mar 2026.

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