Clinical trial NCT06997861: Medication Review Improves Pain Management and Quality of Life in Chronic Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Medication Review
Chronic Pain
Quality of Life
Pharmaceutical Care
Primary Care
Lead sponsor: Polytechnic Institute of Porto
Sponsor class: OTHER
Collaborators: name: University of Salamanca
First posted: 2025-05-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blinded, randomized study
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity
timeFrame: From enrollment to the end of the interventions at 16 weeks
Secondary outcomes:
measure: Quality of Life (QoL)
timeFrame: From enrollment to the end of the interventions at 16 weeks
measure: Satisfaction with treatment
timeFrame: From enrollment to the end of the interventions at 16 weeks
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro de Investigação em Saúde e Ambiente (CISA) - School of Health of the Polytechnic Institute of Porto
Study officials:
References:
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citation: Dworkin 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.
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