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NCT Number: NCT07273084

Multidisciplinary Intervention for Non-Cancer Chronic Pain: Pilot Study

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.

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Key information

Conditions

Non-cancer Pain Chronic Non-cancer Pain

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benicassim Health Center

Benicassim, Castellón, 12560, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

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

    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).

Secondary outcomes

  1. Pain Intensity Measured With the Visual Analog Scale (VAS)

    Time frame: Baseline, post-intervention, 3 months.

    Pain intensity will be measured using the Visual Analog Scale (VAS), a 100-mm line ranging from 0 (no pain) to 100 (worst imaginable pain). Higher scores indicate worse pain intensity.

  2. Central Sensitization Assessed With the Central Sensitization Inventory (CSI)

    Time frame: Baseline, immediately after the intervention, and 3 months after intervention completion.

    Central sensitization will be assessed using the Central Sensitization Inventory (CSI), consisting of 25 items scored from 0 to 4. The total score ranges from 0 (no symptoms) to 100 (maximum symptom severity). Higher scores indicate worse central sensitization.

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

    Time frame: Baseline, immediately after the intervention, and 3 months after intervention completion.

    Fear of movement will be assessed using the 11-item Tampa Scale for Kinesiophobia (TSK-11). Scores range from 11 (lowest fear) to 44 (highest fear). Higher scores indicate worse kinesiophobia.

  4. Pain Catastrophizing Measured With the Pain Catastrophizing Scale (PCS)

    Time frame: Baseline, immediately after the intervention, and 3 months after intervention completion.

    Pain catastrophizing will be measured using the Pain Catastrophizing Scale (PCS), a 13-item questionnaire. Scores range from 0 (no catastrophizing) to 52 (maximum catastrophizing). Higher scores indicate worse catastrophizing.

  5. Sleep Quality Assessed With the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline, immediately after the intervention, and 3 months after intervention completion.

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 (better sleep quality) to 21 (poorer sleep quality). Higher scores indicate worse sleep quality.

  6. Anxiety and Depression Assessed With the Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline, immediately after the intervention, and 3 months after intervention completion.

    Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS), which includes two subscales (anxiety and depression), each ranging from 0 (no symptoms) to 21 (severe symptoms). Higher scores indicate worse anxiety or depression.

  7. Perceived Social Support Measured With the Duke-UNC Functional Social Support Questionnaire

    Time frame: Baseline, immediately after the intervention, and 3 months after intervention completion.

    Perceived social support will be assessed using the Duke-UNC Functional Social Support Questionnaire. Scores range from 8 (lowest support) to 40 (highest support). Higher scores indicate better perceived social support.

Sponsors and collaborators

Lead sponsor

Victor Ortiz Mallasen

Other

Registry information

Official study title

Multidisciplinary Intervention in Patients With Non-Cancer Chronic Pain in a Primary Care Center: Pilot Study

Acronym: MICNP

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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