Active Coping Program for Chronic Musculoskeletal Pain: A Controlled Clinical Study

NCT ID: NCT07322822

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2026-10-01

Brief Summary

Chronic musculoskeletal pain is a highly prevalent condition that is often associated with persistent pain, physical disability, and maladaptive psychosocial factors such as pain catastrophizing, fear of movement, and central sensitization. These factors can contribute to pain persistence and reduced quality of life, highlighting the need for multimodal, non-pharmacological interventions that address both physical and psychological dimensions of pain.

The purpose of this study is to evaluate the effectiveness of an active coping program for patients with chronic musculoskeletal pain compared with usual care. The intervention is designed to promote active pain management strategies through education, movement-based exercises, and behavioral approaches aimed at improving pain coping, reducing disability, and addressing psychosocial contributors to chronic pain.

This is a controlled interventional study in which adult patients with chronic musculoskeletal pain will be allocated to either an intervention group receiving the active coping program or a control group receiving usual care. Outcome measures will be assessed at baseline and after completion of the intervention. Primary and secondary outcomes include pain-related disability, pain catastrophizing, fear of movement, symptoms of central sensitization, and health-related quality of life, measured using validated questionnaires.

The findings of this study are expected to provide evidence on the clinical effectiveness of an active coping approach in the management of chronic musculoskeletal pain and to support its implementation in routine clinical practice within primary care settings.

Conditions

Chronic Musculoskeletal Pain; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Coping Program

Group Type: EXPERIMENTAL

Active Coping Program

Intervention Type: BEHAVIORAL

Participants assigned to this arm will receive an 8-week active coping program for chronic musculoskeletal pain. The program is a multimodal, non-pharmacological intervention aimed at improving self-management and active pain coping. Core components include pain education (e.g., understanding chronic pain mechanisms), movement-based therapeutic exercise/graded activity, and behavioral strategies to address maladaptive pain-related beliefs and behaviors (e.g., fear of movement and pain catastrophizing). The intervention is delivered following a standardized protocol to ensure consistency across participants.

Usual Care

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Participants assigned to this arm will receive usual care as provided in routine clinical practice in primary care. No additional study-specific intervention is delivered. Usual care may include standard medical management, general advice and education, and referral to other services as clinically indicated, according to local practice.

Interventions

Active Coping Program

Participants assigned to this arm will receive an 8-week active coping program for chronic musculoskeletal pain. The program is a multimodal, non-pharmacological intervention aimed at improving self-management and active pain coping. Core components include pain education (e.g., understanding chronic pain mechanisms), movement-based therapeutic exercise/graded activity, and behavioral strategies to address maladaptive pain-related beliefs and behaviors (e.g., fear of movement and pain catastrophizing). The intervention is delivered following a standardized protocol to ensure consistency across participants.

Intervention Type: BEHAVIORAL

Usual Care

Participants assigned to this arm will receive usual care as provided in routine clinical practice in primary care. No additional study-specific intervention is delivered. Usual care may include standard medical management, general advice and education, and referral to other services as clinically indicated, according to local practice.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults aged 18 years or older.

Diagnosis of chronic musculoskeletal pain, defined as pain persisting for more than 3 months.

Ability to understand study procedures and complete self-reported questionnaires.

Ability to participate in an active coping program involving education and movement-based activities.

Provision of written informed consent.

Exclusion Criteria

• Presence of serious neurological, rheumatologic, or systemic disease that may interfere with participation in the intervention or outcome assessment.

Severe cognitive impairment or psychiatric condition that limits understanding of the study procedures.

Ongoing participation in another structured pain management or rehabilitation program.

Any medical condition that, in the opinion of the investigators, would make participation unsafe or compromise study results.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Extremadura

OTHER

Sponsor Role: lead

Responsible Party

Carlos Fernández-Morales

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis Espejo-Antúnez, Ph.D.

Role: STUDY_DIRECTOR

University of Extremadura

Locations

University of Extremadura

Badajoz, Badajoz, Spain

Countries

Spain

Central Contacts

Carlos Fernández-Morales, Ph.D.

Role: CONTACT

carlosfm@unex.es

+34924289829 ext. 89829

Facility Contacts

Carlos Fernández-Morales, Ph.D.

Role: primary

carlosfm@unex.es

+34 924289829 ext. 89829

Other Identifiers

11

Identifier Type: -

Identifier Source: org_study_id