Clinical trial · Interventional
Effectiveness of Coping Strategies on the Control of Chronic Non-Cancer Pain and Quality of Life (CNCP_CopQol)
Effectiveness of Coping Strategies on the Control of Musculoskeletal Chronic Non-Cancer Pain and Quality of Life: A Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* Introduction and objectives: Non-pharmacological interventions in patients with musculoskeletal chronic non-cancer pain (mCNCP) are positioning themselves as an essential pillar in treatment along with pharmacological and interventional treatment. Training the patient in psycho-educational interventions focused on the neuroscience of pain and accompanying them towards a better coping of their disease can decrease the perception of pain and improve their quality of life. A previous pilot study, developed by the researchers about this type of interventions, identified as relevant data an improvement in the quality of life (QoL) of patients with mCNCP with a significant decrease in pharmacological consumption, and a high degree of satisfaction on the part of the user through the analysis of PROMs (patient-reported outcome measures). The main objective of this study is to know the effectiveness in the perception of pain through the Verbal Numerical Rating Scale (VNRS) and in the quality of life through the EuroQol-5D (EQ-5D) questionnaire of a psychoeducational intervention focused on emotional coping strategies, in patients with mCNCP in the Primary Care Centres of Public Health System of Aljarafe-Sevilla Norte Area (Spain). Secondarily, the consumption of health resources associated with mCNCP, the adherence to treatment, the influence of social, emotional, and family variables will be studied by the researchers in the two groups of patients on each telephone assessment. * Methodology: Prospective, randomized, triple-blind (patient, investigator, and analysis) and controlled clinical trial. Participants with mCNCP in follow-up in Primary Care without clinical control with the treatment scheduled and who agree to participate in the study will be randomized by blocks permuted to receive treatments and standard care (control group) or these same care plus a psychoeducational intervention (experimental group). This intervention consists of an emotional self-regulation training program of four face-to-face sessions of 3 hours each, over a four-week period. The study will include 144 participants (72 for each arm). Patient follow-up will be telephone at the time of inclusion, at month, three, and six months. A descriptive and multivariate analysis will be done with the patients' research data associated with pain or QoL, post-intervention. * Ethics and dissemination: The study will be carried out following the Helsinki Declaration and is approved by the Committee on Ethics of Research of Virgen Macarena- Virgen del Rocío university hospitals in Seville, Spain (code 1589-N-19). The results of the trial will be published under CONSORT regulations and SPIRIT guideline.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pain | — | UNRESOLVED | — |
| Musculoskeletal Diseases | — | UNRESOLVED | — |
| Pain Measurement | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psychoeducative intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Standard pharmacological treatment aimed at controlling mCNCP with four-week face to face psychoeducational intervention.
- interventionNames
- Behavioral: Psychoeducative intervention
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Standard pharmacological treatment aimed at controlling mCNCP without psychoeducational intervention.
Primary outcomes (2)
- measure
- Change from Baseline Pain perception
- timeFrame
- Baseline and six months.
- description
- It is measured by Verbal Numerical Rate Scale (NVRS). The NVRS will be used for its simplicity and reproducibility and in patients without cognitive impairment has a compliance close to 100%. Quantitative result by 0 to 10, where 0 is painless and 10 is as much pain as possible.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA: * People over the age of 18. * People with mCNCP served for this reason in the Primary Care Centres depend on Hospital San Juan de Dios del Aljarafe, who follow regular specific treatment on the WHO analgesic scale and who have accepted, after information and informed consent signature, their participation in this study. * Able to read and write Spanish. EXCLUSION CRITERIA: * Patients who have received interventional analgesic treatment in the year for the current disease. * Have followed program or maintain out-of-hospital therapy similar to the one this study focuses on. * Have had surgery or been on a waiting list during the study. * Severe or decompensated systemic disease. * Active cancer disease. * Psychiatric pathology, epilepsy or cognitive impairment. * Abuse drug addiction. * Accidents or new Injuries that may increase the perception of pain during the study. * Labor litigation due to pain. * Language barrier. LOSS CRITERIA: * Voluntary abandonment of the study. * Absence of one or more workshop sessions * Partial or complete loss of telephone follow-up. * Incomplete data collection. * Exitus. * Present any suspicious symptoms of COVID-19 disease collected by phone call the day before the workshop or communicate direct contact with a person infected in the previous days.
References
Publications (23)
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- BACKGROUNDCrofford LJ. Chronic Pain: Where the Body Meets the Brain. Trans Am Clin Climatol Assoc. 2015;126:167-83. PMID 26330672
- BACKGROUNDTheadom A, Cropley M, Smith HE, Feigin VL, McPherson K. Mind and body therapy for fibromyalgia. Cochrane Database Syst Rev. 2015 Apr 9;2015(4):CD001980. doi: 10.1002/14651858.CD001980.pub3. PMID 25856658
- BACKGROUNDMorone NE, Greco CM, Moore CG, Rollman BL, Lane B, Morrow LA, Glynn NW, Weiner DK. A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):329-37. doi: 10.1001/jamainternmed.2015.8033.