Multimodal Physiotherapy and Pain Coping in Primary Care

NCT ID: NCT07299929

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-09-30

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Musculoskeletal Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Multimodal Physiotherapy Intervention

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.

Group Type EXPERIMENTAL

Multimodal Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic Exercise

Intervention Type 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.

Interventions

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Multimodal Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic Exercise

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitat Jaume I

OTHER

Sponsor Role lead

Responsible Party

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Victor Ortiz Mallasen

Assistant Professor of Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Victor Ortiz-Mallasen

Role: CONTACT

Phone: 34964387810

Email: [email protected]

Other Identifiers

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DC-GVA-2025

Identifier Type: -

Identifier Source: org_study_id