Multidisciplinary Intervention for Non-Cancer Chronic Pain: Pilot Study

NCT07273084 | Completed

• 1 other identifier: PILOT-12PAT-2025
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Non-cancer chronic pain (NCCP) persists beyond the injury that caused it, affecting approximately 20% of the global population (around 1.6 billion people) and 17-18% in Spain (about 8 million people). Its treatment is complex and often insufficient, highlighting the need for an integrated, multimodal, multidisciplinary approach coordinated between primary and hospital care. Objective: To evaluate the effectiveness of a multidisciplinary intervention program combining pain neuroscience education, therapeutic physical exercise, and promotion of healthy habits, aiming to improve health-related quality of life in individuals with NCCP at the Benicàssim Health Center. Methodology: This is a quasi-experimental, before-and-after pilot study, non-randomized, without a control group, using a convenience sample of 12 participants. Sociodemographic, health-related, and clinical variables will be measured, including health-related quality of life, central sensitization, kinesiophobia, catastrophizing, pain level, body mass index, sleep quality, perceived social support, anxiety, and depression. Measurements will be taken before the program, at completion, and at 3 months. The intervention is a 6-week group program with 17 sessions, combining pain neuroscience education, individualized therapeutic exercises, and promotion of healthy habits. Data will be analyzed using SPSS v.29 with a significance level of p\<0.05.

Conditions

Non-cancer Pain; Chronic Non-cancer Pain

Outcome Measures

Primary Outcomes (1)

• Health-Related Quality of Life Measured With the EQ-5D-5L

  Health-related quality of life will be assessed using the EQ-5D-5L questionnaire. The EQ-5D-5L index value typically ranges from less than 0 (worse than death) to 1.00 (full health). Higher scores indicate better health-related quality of life. The EQ-VAS ranges from 0 (worst imaginable health) to 100 (best imaginable health).

  Baseline, immediately after the 6-week program, and 3 months after intervention completion.

Secondary Outcomes (7)

• Pain Intensity Measured With the Visual Analog Scale (VAS)

  Baseline, post-intervention, 3 months.

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

  Baseline, immediately after the intervention, and 3 months after intervention completion.

• Kinesiophobia Measured With the Tampa Scale for Kinesiophobia (TSK-11)

  Baseline, immediately after the intervention, and 3 months after intervention completion.

• Pain Catastrophizing Measured With the Pain Catastrophizing Scale (PCS)

  Baseline, immediately after the intervention, and 3 months after intervention completion.

• Sleep Quality Assessed With the Pittsburgh Sleep Quality Index (PSQI)

  Baseline, immediately after the intervention, and 3 months after intervention completion.

Study Arms (1)

Experimental: Multidisciplinary Intervention

EXPERIMENTAL

All participants will receive a multidisciplinary intervention program lasting 6 weeks, consisting of 17 sessions that combine pain neuroscience education, individualized therapeutic exercises, and promotion of healthy lifestyle habits. The program aims to improve pain management skills and health-related quality of life in patients with non-cancer chronic pain.

Behavioral: Multidisciplinary Intervention Program for Chronic Non-Cancer Pain

Interventions

Multidisciplinary Intervention Program for Chronic Non-Cancer Pain BEHAVIORAL

A 6-week multidisciplinary group program composed of 17 sessions combining pain neuroscience education, individualized therapeutic exercises, and promotion of healthy lifestyle habits. The intervention aims to improve pain management skills, physical function, and health-related quality of life in adults with non-cancer chronic pain.

Experimental: Multidisciplinary Intervention

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged between 18 and 79 years.
• Individuals diagnosed with non-cancer chronic pain lasting more than 3 months.

You may not qualify if:

• Individuals with pain of oncologic origin.
• Individuals who have experienced a fracture or undergone surgery within the past year.
• Pregnant women.
• Individuals without adequate understanding of the Spanish language.
• Individuals with cognitive impairment that prevents them from performing the program's interventions.
• Individuals with physical performance deficits that prevent them from carrying out the program's activities.
• Individuals with urinary and/or fecal incontinence.

Sponsors & Collaborators

• Victor Ortiz Mallasen: lead

Study Sites (1)

Benicassim Health Center

Benicassim, Castellón, 12560, Spain

Location

Study Design

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

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: July 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: February 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)