Multimodal Physiotherapy and Pain Coping in Primary Care

NCT07299929 | Not Yet Recruiting

• 1 other identifier: DC-GVA-2025
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Chronic Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.

• Central Sensitization Assessed With the Central Sensitization Inventory (CSI)

  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)

  Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.

• Treatment Adherence Assessed With a Session Attendance Log

  During the intervention period

Study Arms (1)

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.

Behavioral: Multimodal Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic Exercise

Interventions

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.

Multimodal Physiotherapy Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Persistent nonspecific musculoskeletal pain lasting at least 6 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Jaume I: lead

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Victor Ortiz-Mallasen

CONTACT

34964387810; ortizv@uji.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nursing

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 23, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share