Clinical trial · Interventional
Medication Review Improves Pain Management and Quality of Life in Chronic Pain
Parallel Randomized Study to Determine Pain Intensity and Quality of Life in Patients With Chronic Non-Cancer Pain Receiving Medication Review With Follow-up VS Usual Care
- 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)
The goal of this parallel-group, single-blinded, randomized study is to conduct Medication Review (MR) Type III in chronic non-cancer pain patients to optimize drug therapy and measure it's influence on Pain Intensity and Quality of Life in the primary care setting. The study took place in Porto, Portugal with the collaboration of two Primary Care Units (USF Arca D'Água and USF Campanhã - Polo S. Roque da Lameira) under ACeS Porto Oriental, from where patients were recruited. The main question it aims to answer is: * Does the implementation of pharmacist-led medication review benefit patients with chronic pain in the primary care setting? * Researchers will compare with "Usual Care" (UC) patients which receives general advice on how to manage their pain and/or recommendations to take "over the counter" drugs, similar to community pharmacy visits, to see if there is a clinically significant difference in pain intensity and quality of life between the two groups of patients. * Participants will be asked to attend face-to-face interviews once a month for 4 months with an expert in medication review, that evaluates their current medication and suggests an individualized care plan. These plans include measures aimed at physicians (e.g., medication adding; dose reduction) and participants (e.g., non-pharmacological measures; adherence to medication).
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medication Review Type III | Other | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Medication Review (MR)
- interventionNames
- Other: Medication Review Type III
- type
- ACTIVE_COMPARATOR
- label
- Usual-Care (UC)
- interventionNames
- Other: Usual Care
Primary outcomes (1)
- measure
- Pain Intensity
- timeFrame
- From enrollment to the end of the interventions at 16 weeks
- description
- Following IMMPACT recommendations, subjects will record weekly pain (defined as the average of three measurements in a week) scores in the following manner: In a 11-point NRS with three descriptors where 0 is "no pain", 5 is "moderate pain" and 10 "maximum pain", subjects will select which best describes the pain they felt in the last 24h and record their score in the morning. Also, subjects will be instructed to record their pain scores on the week previous to the interventions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Non-cancer chronic pain (\>3 months, any cause) * Follow-up at one of the selected Primary Care Units * Average weekly pain score ≥4 at the screening phase * Ability to attend monthly in-person or video interviews Exclusion Criteria: * Pregnancy * Breastfeeding * Dementia * Other mental illness impairing self-reporting
References
Publications (12)
- BACKGROUNDMcDermott ME, Smith BH, Elliott AM, Bond CM, Hannaford PC, Chambers WA. The use of medication for chronic pain in primary care, and the potential for intervention by a practice-based pharmacist. Fam Pract. 2006 Feb;23(1):46-52. doi: 10.1093/fampra/cmi068. Epub 2005 Aug 17. PMID 16107494
- BACKGROUNDKadam P, Bhalerao S. Sample size calculation. Int J Ayurveda Res. 2010 Jan;1(1):55-7. doi: 10.4103/0974-7788.59946. No abstract available. PMID 20532100
- BACKGROUNDSabater Hernández D, Milena Castro Silva M, María Faus Dáder J. Método Dáder: manual de seguimento farmacoterapêutico. 3a. Lisboa: Edições Universitárias Lusófonas; 2009
- BACKGROUNDWan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014 Dec 19;14:135. doi: 10.1186/1471-2288-14-135. PMID 25524443
- BACKGROUNDDworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available. PMID 15621359
- BACKGROUNDInternational Pharmaceutical Federation (FIP). International Pharmaceutical Federation (FIP). Medication review and medicines use review: A toolkit for pharmacists. The Hague: International Pharmaceutical Federation; 2022.
- BACKGROUNDGriese-Mammen N, Hersberger KE, Messerli M, Leikola S, Horvat N, van Mil JWF, Kos M. PCNE definition of medication review: reaching agreement. Int J Clin Pharm. 2018 Oct;40(5):1199-1208. doi: 10.1007/s11096-018-0696-7. Epub 2018 Aug 2.