Non-cancer PainMICNPNCT07273084
Multidisciplinary Intervention for Non-Cancer Chronic Pain: Pilot Study
A study testing Multidisciplinary Intervention Program for Chronic Non-Cancer Pain in people with Non-cancer Pain and Chronic Non-cancer Pain, run by Victor Ortiz Mallasen at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Non-cancer Pain, Chronic Non-cancer Pain
- What is being tested?
- Multidisciplinary Intervention Program for Chronic Non-Cancer Pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged between 18 and 79 years.
- Individuals diagnosed with non-cancer chronic pain lasting more than 3 months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multidisciplinary Intervention in Patients With Non-Cancer Chronic Pain in a Primary Care Center: 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.
Read more
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
- Being tested
- Multidisciplinary Intervention Program for Chronic Non-Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary Intervention Program for Chronic Non-Cancer PainBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multidisciplinary Intervention Program for Chronic Non-Cancer Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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.
Measured: Baseline, post-intervention, 3 months.
Central Sensitization Assessed With the Central Sensitization Inventory (CSI)
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.
Measured: Baseline, immediately after the intervention, and 3 months after intervention completion.
Kinesiophobia Measured With the Tampa Scale for Kinesiophobia (TSK-11)
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.
Measured: Baseline, immediately after the intervention, and 3 months after intervention completion.
Pain Catastrophizing Measured With the Pain Catastrophizing Scale (PCS)
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.
Measured: Baseline, immediately after the intervention, and 3 months after intervention completion.
Sleep Quality Assessed With the Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline, immediately after the intervention, and 3 months after intervention completion.
Anxiety and Depression Assessed With the Hospital Anxiety and Depression Scale (HADS)
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.
Measured: Baseline, immediately after the intervention, and 3 months after intervention completion.
Perceived Social Support Measured With the Duke-UNC Functional Social Support Questionnaire
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.
Measured: Baseline, immediately after the intervention, and 3 months after intervention completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Jul 2025
- Primary completion1 Sep 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Victor Ortiz Mallasen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Victor Ortiz Mallasen, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273084
- Sponsor's protocol ID
- PILOT-12PAT-2025
- Acronym
- MICNP
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Intervention in Patients With Non-Cancer Chronic Pain in a Primary Care Center: Pilot Study
- ClinicalTrials.gov ID
- NCT07273084
- Acronym / sponsor ID
- MICNP / PILOT-12PAT-2025
- Conditions
- Non-cancer Pain, Chronic Non-cancer Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Victor Ortiz MallasenUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Multidisciplinary Intervention | Experimental | Behavioral: Multidisciplinary Intervention Program for Chronic Non-Cancer PainAll 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals aged between 18 and 79 years.
- Individuals diagnosed with non-cancer chronic pain lasting more than 3 months.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary Intervention Program for Chronic Non-Cancer PainA 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. | Behavioural | Experimental: Multidisciplinary Intervention |
Primary outcome
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).
7 secondary outcomes
Pain Intensity Measured With the Visual Analog Scale (VAS)
Time frame: Baseline, post-intervention, 3 months.
Central Sensitization Assessed With the Central Sensitization Inventory (CSI)
Time frame: Baseline, immediately after the intervention, and 3 months after intervention completion.
Kinesiophobia Measured With the Tampa Scale for Kinesiophobia (TSK-11)
Time frame: Baseline, immediately after the intervention, and 3 months after intervention completion.
Pain Catastrophizing Measured With the Pain Catastrophizing Scale (PCS)
Time frame: Baseline, immediately after the intervention, and 3 months after intervention completion.
Sleep Quality Assessed With the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, immediately after the intervention, and 3 months after intervention completion.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary Intervention Program for Chronic Non-Cancer Pain in people with Non-cancer Pain and Chronic Non-cancer Pain, run by Victor Ortiz Mallasen at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.