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

NCT07322822 | Completed

• 1 other identifier: 11
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Pain Catastrophizing Scale (PCS)

  The Pain Catastrophizing Scale (PCS) is a self-reported questionnaire assessing catastrophic thinking related to pain, including rumination, magnification, and helplessness. The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing (worse outcome).

  Baseline (Week 0) and post-intervention (Week 8)

• Roland-Morris Disability Questionnaire (RMDQ)

  The Roland-Morris Disability Questionnaire (RMDQ) is a self-reported questionnaire assessing pain-related physical disability in daily activities. The total score ranges from 0 to 24, with higher scores indicating greater disability (worse outcome).

  Baseline (Week 0) and post-intervention (Week 8)

• Tampa Scale for Kinesiophobia (TSK-11)

  The Tampa Scale for Kinesiophobia - 11 item version (TSK-11) is a self-reported questionnaire assessing fear of movement and re-injury related to pain. Total scores range from 11 to 44, with higher scores indicating greater kinesiophobia (worse outcome).

  Baseline (Week 0) and post-intervention (Week 8)

• Central Sensitization Inventory (CSI)

  The Central Sensitization Inventory (CSI) is a self-reported questionnaire used to assess symptoms associated with central sensitization. The total score ranges from 0 to 100, with higher scores indicating greater symptom severity related to central sensitization (worse outcome).

  Baseline (Week 0) and post-intervention (Week 8)

• 36-Item Short Form Health Survey (SF-36)

  The 36-Item Short Form Health Survey (SF-36) is a generic self-reported questionnaire assessing health-related quality of life across multiple physical and mental health domains. Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life (better outcome).

  Baseline (Week 0) and post-intervention (Week 8)

Study Arms (2)

Active Coping Program

EXPERIMENTAL

Behavioral: Active Coping Program

Usual Care

ACTIVE COMPARATOR

Other: Usual Care

Interventions

Usual Care 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.

Usual Care

Active Coping Program 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.

Active Coping Program

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Extremadura: lead

Study Sites (1)

University of Extremadura

Badajoz, Badajoz, 06006, Spain

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luis Espejo-Antúnez, Ph.D.

  University of Extremadura

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 7, 2026
• Study Start: February 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)