Chronic PainNCT06997861
Medication Review Improves Pain Management and Quality of Life in Chronic Pain
A study testing Medication Review Type III in people with Chronic Pain, run by Polytechnic Institute of Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Medication Review Type III
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 3 Nov 2023to 26 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Breastfeeding
- Dementia
- Other mental illness impairing self-reporting
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro de Investigação em Saúde e Ambiente (CISA) - School of Health of the Polytechnic Institute of Porto
Porto, 4200-072
About this study
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
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
- Being tested
- Medication Review Type III, Usual Care
- Keywords
- Medication Review, Chronic Pain, Quality of Life, Pharmaceutical Care, Primary Care
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Review Type IIIOther
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.
Usual CareOther
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.)
| Study group | Role | What they receive |
|---|---|---|
| Medication Review (MR) | Experimental | Not described Receives: Other: Medication Review Type III |
| Usual-Care (UC) | Active comparator | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the interventions at 16 weeks
Secondary outcomes (2)
Quality of Life (QoL)
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.
Measured: From enrollment to the end of the interventions at 16 weeks
Satisfaction with treatment
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.
Measured: From enrollment to the end of the interventions at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start3 Nov 2023
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-blinded, randomized study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polytechnic Institute of Porto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salamanca
- Responsible party
- Principal investigator, Nuno Miguel da Silva Duarte, Polytechnic Institute of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997861
- Sponsor's protocol ID
- CE/2023/87
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the study (including de-identified individual-level data) will be made available upon reasonable request. The data will include all variables used in the analysis relevant to the primary and secondary outcomes, excluding any information that could compromise participant privacy or confidentiality.
Publications
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.
PubMed 16107494Kadam 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.
PubMed 20532100Sabater Hernández D, Milena Castro Silva M, María Faus Dáder J. Método Dáder: manual de seguimento farmacoterapêutico. 3a. Lisboa: Edições Universitárias Lusófonas; 2009
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.
PubMed 25524443Dworkin 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.
PubMed 15621359International Pharmaceutical Federation (FIP). International Pharmaceutical Federation (FIP). Medication review and medicines use review: A toolkit for pharmacists. The Hague: International Pharmaceutical Federation; 2022.
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.
PubMed 30073611Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm. 1990 Mar;47(3):533-43.
PubMed 2316538Domingues L, Cruz E. Adaptação Cultural e Contributo para a Validação da Escala Patient Global Impression of Change. Ifisionline. 2011;2(1):31-7
Cleeland CS. The Brief Pain Inventory User Guide. University of Texas ; 2009
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
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.
PubMed 41461687
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06997861
- Acronym / sponsor ID
- CE/2023/87
- Conditions
- Chronic Pain
- Keywords
- Medication Review, Chronic Pain, Quality of Life, Pharmaceutical Care, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Polytechnic Institute of PortoUniversity, hospital or other
- Collaborators
- University of Salamanca
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single-blinded, randomized study
| Arm | Type | Receives |
|---|---|---|
| Medication Review (MR) | Experimental | Other: Medication Review Type III |
| Usual-Care (UC) | Active comparator | Other: Usual Care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy
- Breastfeeding
- Dementia
- Other mental illness impairing self-reporting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication Review Type IIIThe 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. | Other | Medication Review (MR) |
| Usual CareThe 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.) | Other | Usual-Care (UC) |
Primary outcome
Pain Intensity
Time frame: 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.
2 secondary outcomes
Quality of Life (QoL)
Time frame: From enrollment to the end of the interventions at 16 weeks
Satisfaction with treatment
Time frame: From enrollment to the end of the interventions at 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Background: PubMed 16107494McDermott 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.
- Background: PubMed 20532100Kadam 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.
- BackgroundSabater Hernández D, Milena Castro Silva M, María Faus Dáder J. Método Dáder: manual de seguimento farmacoterapêutico. 3a. Lisboa: Edições Universitárias Lusófonas; 2009
- Background: PubMed 25524443Wan 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.
- Background: PubMed 15621359Dworkin 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.
- BackgroundInternational Pharmaceutical Federation (FIP). International Pharmaceutical Federation (FIP). Medication review and medicines use review: A toolkit for pharmacists. The Hague: International Pharmaceutical Federation; 2022.
- Background: PubMed 30073611Griese-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.
- Background: PubMed 2316538Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm. 1990 Mar;47(3):533-43.
- Results publicationDomingues L, Cruz E. Adaptação Cultural e Contributo para a Validação da Escala Patient Global Impression of Change. Ifisionline. 2011;2(1):31-7
- Results publicationCleeland CS. The Brief Pain Inventory User Guide. University of Texas ; 2009
- Results publicationFerreira-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
- Derived from this study: PubMed 41461687Duarte 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the study (including de-identified individual-level data) will be made available upon reasonable request. The data will include all variables used in the analysis relevant to the primary and secondary outcomes, excluding any information that could compromise participant privacy or confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Review Type III in people with Chronic Pain, run by Polytechnic Institute of Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: From enrollment to the end of the interventions at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06997861, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.