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

NCT06997861 | Completed

• 1 other identifier: CE/2023/87
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Pain

Keywords

Medication Review; Chronic Pain; Quality of Life; Pharmaceutical Care; Primary Care

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  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.

  From enrollment to the end of the interventions at 16 weeks

Secondary Outcomes (2)

• Quality of Life (QoL)

  From enrollment to the end of the interventions at 16 weeks

• Satisfaction with treatment

  From enrollment to the end of the interventions at 16 weeks

Study Arms (2)

Medication Review (MR)

EXPERIMENTAL

Other: Medication Review Type III

Usual-Care (UC)

ACTIVE COMPARATOR

Other: Usual Care

Interventions

Medication Review Type III OTHER

The MR arm will receive four MR interviews. In the first MR, information about the patient's personal and medical history, along with current health problems, relevant lab exams and medication will be gathered. This will be used to proceed with medication review process and assessment of Drug Related Problems (DRP) that may lead to negative medication results. A personalized care plan will be developed to correct any detected DRP, delivered in writing/e-mail to the patient and carefully explained. Some DRP's may need the physician's intervention to correct. In these cases, a detailed recommendation will be sent to the patient's physician via email. All physicians' recommendations acted upon or not, will be recorded. Subsequent interviews will assess patient compliance with the care plan and if necessary, adjustments will be made accordingly.

Medication Review (MR)

Usual Care OTHER

The UC arm will receive an intervention by the investigator at the same time frame defined for the MR arm. The intervention will also consist of interviews, although MR will not be conducted. The investigator will ask questions to the patient about is drug therapy in a similar fashion to what would happen in the community pharmacy. Simple advice and information will be carried out (i.e., reinforcement of adherence, explanation about indication of drugs etc.)

Usual-Care (UC)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Breastfeeding
• Dementia
• Other mental illness impairing self-reporting

Sponsors & Collaborators

• Polytechnic Institute of Porto: lead
• University of Salamanca: collaborator

Study Sites (1)

Centro de Investigação em Saúde e Ambiente (CISA) - School of Health of the Polytechnic Institute of Porto

Porto, 4200-072, Portugal

Location

Related Publications (12)

• McDermott 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 BACKGROUND

• Kadam 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 BACKGROUND

• Domingues L, Cruz E. Adaptação Cultural e Contributo para a Validação da Escala Patient Global Impression of Change. Ifisionline. 2011;2(1):31-7

  BACKGROUND

• Cleeland CS. The Brief Pain Inventory User Guide. University of Texas ; 2009

  BACKGROUND

• Ferreira-Valente MA, Pais-Ribeiro JL, Jensen M. Further Validation of a Portuguese Version of the Brief Pain Inventory Interference Scale. Clin Salud. 2012;23(1):89-96

  BACKGROUND

• Sabater Hernández D, Milena Castro Silva M, María Faus Dáder J. Método Dáder: manual de seguimento farmacoterapêutico. 3a. Lisboa: Edições Universitárias Lusófonas; 2009

  BACKGROUND

• Wan 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 BACKGROUND

• 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.

  PMID: 15621359 BACKGROUND

• International Pharmaceutical Federation (FIP). International Pharmaceutical Federation (FIP). Medication review and medicines use review: A toolkit for pharmacists. The Hague: International Pharmaceutical Federation; 2022.

  BACKGROUND

• Griese-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.

  PMID: 30073611 BACKGROUND

• Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm. 1990 Mar;47(3):533-43.

  PMID: 2316538 BACKGROUND

• Duarte N, Martins JP, Garcia-Domingo M, Garcia-Pedraza JA, Santos M. Medication review improves pain management and quality of life in chronic pain: a pilot randomized controlled study. Sci Rep. 2025 Dec 29;15(1):44689. doi: 10.1038/s41598-025-28475-8.

  PMID: 41461687 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This trial is blinded to subjects. Each subject will be informed they will be allocated to one of the two arms without knowing which one. Subjects will know they will receive pharmaceutical care, despite not knowing what type of pharmaceutical care they will receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single-blinded, randomized study

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: May 30, 2025
• Study Start: November 3, 2023
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The IPD will be available beginning 6 months after publication of the primary results and will remain available for up to 4 years following publication.
• Access Criteria: Researchers who provide a methodologically sound proposal and have appropriate institutional approval may request access. Proposals should be submitted to the study principal investigator via email. A data use agreement will be required prior to the release of data.

Locations

PT (1)