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NCT Number: NCT07299929

Multimodal Physiotherapy and Pain Coping 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.

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.

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Key information

Conditions

Chronic Musculoskeletal Pain

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persistent nonspecific musculoskeletal pain lasting at least 6 months

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Multimodal Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic Exercise

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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.

  5. Treatment Adherence Assessed With a Session Attendance Log

    Time frame: During the intervention period

    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.

  6. Patient Satisfaction Measured With a Likert-Type Satisfaction Questionnaire

    Time frame: Immediately after the intervention.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Victor Ortiz-Mallasen

CONTACT

[email protected]

34964387810

Sponsors and collaborators

Lead sponsor

Universitat Jaume I

Other

Registry information

Official study title

Multimodal Physiotherapy Intervention for Active Coping With Persistent Musculoskeletal Pain in Primary Care

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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