Medication Review Improves Pain Management and Quality of Life in Chronic Pain

Not Applicable

Completed

• Conditions: Chronic Pain

• Registration Number: NCT06997861
• Lead Sponsor: Polytechnic Institute of Porto

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-03
• Primary Completion: 2024-06-26
• Study Completion: 2024-06-26
• Status Verified: 2025-05
• Study First Submitted: 2025-05-18
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Intensity	From enrollment to the end of the interventions at 16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QoL)	From enrollment to the end of the interventions at 16 weeks	In this study and according to the IMMPACT recommendations, the Brief Pain Inventory-short form (BPI) will be used to measure the pain interference using the interference scale of this QoL measurement instrument. Data regarding this outcome will be collected and registered in a similar fashion to PI. Patients will be instructed to fill out the BPI short form in paper in the same day they measure their third PI score.
Satisfaction with treatment	From enrollment to the end of the interventions at 16 weeks	In accordance with IMMPACT recommendations, the Patient Global Impression of Change (PGIC) scale will be used to determine participants global satisfaction with interventions. The PGIC scale was adapted from the Clinical Global Impression scale, proposed for patients with schizophrenia. It is a unidimensional scale which consists of a 7-rating scale where 1 = "no change" up to 7 = "very much improved". Data regarding this outcome will be collected and registered in a similar fashion to primary outcomes. Patients will be instructed to fill out the PGIC on paper in the same day they measure their third PI score and BPI.

Trial Locations

Locations (1)

Centro de Investigação em Saúde e Ambiente (CISA) - School of Health of the Polytechnic Institute of Porto; 🇵🇹 Porto, Portugal