Osteoarthritis, KneeNCT03146689
Ibuprofen Gel or Capsaicin Cream for my Painful Knee Osteoarthritis?
A study testing Topical NSAID and Topical Capsaicin in people with Osteoarthritis, Knee, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Despite evidence that topical non-steroidal anti-inflammatory drugs (NSAIDs) and capsaicin are effective in osteoarthritis (OA), it is still unclear why they work for some people but not others. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Topical NSAID and Topical Capsaicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Aug 2017to 16 Oct 2018
- 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 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and non-pregnant women who have had ultrasound and radiographic assessments in the Knee Pain in the Community study
- o Premenopausal women will need to be on an acceptable contraceptive method
- Aged 40-95 years
- Knee pain between 4-8 on the NRS
- Knee osteoarthritis - defined as knee pain plus radiographic changes, based on previous questionnaire responses and radiographic findings
- Knee pain: individuals with knee pain in and around the knee on most days for at least a month.
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- Radiographic changes: definite joint space narrowing and definite osteophytes (each scoring two or more on the Nottingham Line Drawing Atlas) in the tibiofemoral and/or patellofemoral compartments
- Predominantly neuropathic or inflammatory phenotypes based on previous questionnaire responses (not current status)
- Predominantly neuropathic phenotype: painDETECT Questionnaire (PDQ) > 13 and synovial hypertrophy (SH) <4 mm
- Predominantly inflammatory phenotype: SH > 4 mm and PDQ < 13
- If we cannot recruit enough people with the above thresholds, we will base recruitment on the overall distribution of PDQ and SH scores from the population. The third tertile of PDQ and the first tertile of SH for neuropathic and the first tertile of PDQ and the third tertile of SH for inflammatory phenotypes.
Who cannot join
- Inability to give informed consent
- Daily use of oral NSAIDs for the last two weeks
- Prior use of Ibuprofen gel or Zacin on the affected knee(s)
- Terminal or untreated major mental illness
- Pregnancy or breastfeeding
- Hypersensitivity or allergy to topical NSAIDs, capsaicin, or other ingredients in the preparations. This includes individuals that experience attacks of asthma, urticaria, or acute rhinitis that are precipitated by NSAIDs
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- Current treatment for stomach or duodenal ulcers
- Total joint replacement of affected joint
- Renal failure
- Taking anticoagulants
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Rheumatology, University of Nottingham
Nottingham, Nottinghamshire, NG5 1PB
About this study
Official title: Identifying Treatment Responders to a Topical Non-steroidal Anti-inflammatory Drug (NSAID) or Topical Capsaicin in Painful Knee Osteoarthritis: A Pilot Series of N-of-1 Trials
Despite evidence that topical non-steroidal anti-inflammatory drugs (NSAIDs) and capsaicin are effective in osteoarthritis (OA), it is still unclear why they work for some people but not others. The investigators are undertaking an individual patient data (IPD) meta-analysis to identify responders according to patient characteristics, however, no studies report the presence of synovial hypertrophy or neuropathic-like pain. These two traits are of interest as they may be used to optimise the treatment effects of the two drugs which work via different mechanisms to reduce pain in OA. The investigators are therefore conducting this pilot n-of-1 trial series.
This pilot n-of-1 trial series will investigate whether a person with OA, who has a different balance between inflammatory and neuropathic pain, shows a preference between these mechanistically different treatments. The trial will also be used to offer recommendations on the use of n-of-1 trial series for individualised (precision) medicine in OA.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Topical NSAID, Topical Capsaicin
- Keywords
- osteoarthritis, n-of-1, ibuprofen, capsaicin, NSAID, topical
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical NSAIDDrug
Also called Ibuprofen 5% gel
Applied four times daily
Topical CapsaicinDrug
Also called Zacin 0.025% cream
Applied four times daily
| Study group | Role | What they receive |
|---|---|---|
| Topical NSAID and topical capsaicin | Experimental | Within each participant:
Topical NSAID (A) or capsaicin (B) are taken for a treatment period of four weeks. This is followed by another four week treatment period with the other treatment. These two treatment periods comprise one treatment cycle. The order of treatments within a treatment cycle is determined randomly (AB or BA).
This treatment cycle is repeated so that all participants undergo a maximum of three topical NSAID treatment periods and three topical capsaicin treatment periods (i.e., three treatment cycles). This is reduced to two cycles if they are found to meet the criteria for response at the interim analysis (after cycle two). Receives: Drug: Topical NSAID; Drug: Topical Capsaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline knee pain on 0-10 numeric rating scale (NRS)
Pain experienced in the most painful knee in the past week will be recorded. The following question will be asked for this purpose: "In the past week, on average, how intense was your knee pain rated on a 0-10 scale, where 0 is 'no pain' and 10 is 'pain as bad as could be'?". The change in pain score between period baseline and period end will be calculated
Measured: Baseline and end of each treatment period (i.e., after four weeks of treatment)
Secondary outcomes (3)
End-of-cycle treatment preference
"Considering only the pain relief experienced in this most recent cycle, which treatment do you feel provided satisfactory pain relief?"
Measured: At the end of each treatment cycle (i.e., after 4 weeks of NSAID and 4 weeks of capsaicin).
End-of-study overall treatment preference
"Considering all the aspects of the treatment, including its effectiveness and ease of application, which treatment do you prefer?"
Measured: At study completion - following six treatment periods (24 weeks of treatment, excluding washouts) or 4 treatment periods for responders at the interim analysis (16 weeks of treatment, excluding washouts)
Weekly knee pain on 0-10 numeric rating scale (NRS)
Pain experienced in the most painful knee in the past week will be recorded. The following question will be asked for this purpose: "In the past week, on average, how intense was your knee pain rated on a 0-10 scale, where 0 is 'no pain' and 10 is 'pain as bad as could be'?".
Measured: At end of week 1, week 2, week 3, and week 4 of each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start4 Aug 2017
- Primary completion16 Oct 2018
- Study completion16 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- N-of-1 trial series: several within-individual, randomised, multiple cross-over trials aggregated into a series.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Research UK Pain Centre, Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Weiya Zhang, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146689
- Sponsor's protocol ID
- B 10022017
- Status last verified
- Apr 2019
- First submitted
- 3 May 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for the IPD can be made to the Prof Weiya Zhang. Raw de-identified data may be shared
Publications
Persson MSM, Stocks J, Sarmanova A, Fernandes G, Walsh DA, Doherty M, Zhang W. Individual responses to topical ibuprofen gel or capsaicin cream for painful knee osteoarthritis: a series of n-of-1 trials. Rheumatology (Oxford). 2021 May 14;60(5):2231-2237. doi: 10.1093/rheumatology/keaa561.
PubMed 33197270
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Treatment Responders to a Topical Non-steroidal Anti-inflammatory Drug (NSAID) or Topical Capsaicin in Painful Knee Osteoarthritis: A Pilot Series of N-of-1 Trials
- ClinicalTrials.gov ID
- NCT03146689
- Acronym / sponsor ID
- B 10022017
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, n-of-1, ibuprofen, capsaicin, NSAID, topical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Arthritis Research UK Pain Centre, Nottingham University Hospitals NHS Trust
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 16 Oct 2018 (actual)
- First posted
- 10 May 2017 (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.
Despite evidence that topical non-steroidal anti-inflammatory drugs (NSAIDs) and capsaicin are effective in osteoarthritis (OA), it is still unclear why they work for some people but not others. The investigators are undertaking an individual patient data (IPD) meta-analysis to identify responders according to patient characteristics, however, no studies report the presence of synovial hypertrophy or neuropathic-like pain. These two traits are of interest as they may be used to optimise the treatment effects of the two drugs which work via different mechanisms to reduce pain in OA. The investigators are therefore conducting this pilot n-of-1 trial series.
This pilot n-of-1 trial series will investigate whether a person with OA, who has a different balance between inflammatory and neuropathic pain, shows a preference between these mechanistically different treatments. The trial will also be used to offer recommendations on the use of n-of-1 trial series for individualised (precision) medicine in OA.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- N-of-1 trial series: several within-individual, randomised, multiple cross-over trials aggregated into a series.
| Arm | Type | Receives |
|---|---|---|
| Topical NSAID and topical capsaicin | Experimental | Drug: Topical NSAID, Drug: Topical CapsaicinWithin each participant: Topical NSAID (A) or capsaicin (B) are taken for a treatment period of four weeks. This is followed by another four week treatment period with the other treatment. These two treatment periods comprise one treatment cycle. The order of treatments within a treatment cycle is determined randomly (AB or BA). This treatment cycle is repeated so that all participants undergo a maximum of three topical NSAID treatment periods and three topical capsaicin treatment periods (i.e., three treatment cycles). This is reduced to two cycles if they are found to meet the criteria for response at the interim analysis (after cycle two). |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and non-pregnant women who have had ultrasound and radiographic assessments in the Knee Pain in the Community study
- o Premenopausal women will need to be on an acceptable contraceptive method
- Aged 40-95 years
- Knee pain between 4-8 on the NRS
- Knee osteoarthritis - defined as knee pain plus radiographic changes, based on previous questionnaire responses and radiographic findings
Key exclusion criteria (10 listed)
- Inability to give informed consent
- Daily use of oral NSAIDs for the last two weeks
- Prior use of Ibuprofen gel or Zacin on the affected knee(s)
- Terminal or untreated major mental illness
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Topical NSAIDAlso: Ibuprofen 5% gelApplied four times daily | Drug | Topical NSAID and topical capsaicin |
| Topical CapsaicinAlso: Zacin 0.025% creamApplied four times daily | Drug | Topical NSAID and topical capsaicin |
Primary outcome
Change from baseline knee pain on 0-10 numeric rating scale (NRS)
Time frame: Baseline and end of each treatment period (i.e., after four weeks of treatment)
Pain experienced in the most painful knee in the past week will be recorded. The following question will be asked for this purpose: "In the past week, on average, how intense was your knee pain rated on a 0-10 scale, where 0 is 'no pain' and 10 is 'pain as bad as could be'?". The change in pain score between period baseline and period end will be calculated
3 secondary outcomes
End-of-cycle treatment preference
Time frame: At the end of each treatment cycle (i.e., after 4 weeks of NSAID and 4 weeks of capsaicin).
End-of-study overall treatment preference
Time frame: At study completion - following six treatment periods (24 weeks of treatment, excluding washouts) or 4 treatment periods for responders at the interim analysis (16 weeks of treatment, excluding washouts)
Weekly knee pain on 0-10 numeric rating scale (NRS)
Time frame: At end of week 1, week 2, week 3, and week 4 of each treatment period.
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 18 Apr 2019.
- Derived from this study: PubMed 33197270Persson MSM, Stocks J, Sarmanova A, Fernandes G, Walsh DA, Doherty M, Zhang W. Individual responses to topical ibuprofen gel or capsaicin cream for painful knee osteoarthritis: a series of n-of-1 trials. Rheumatology (Oxford). 2021 May 14;60(5):2231-2237. doi: 10.1093/rheumatology/keaa561.
- Individual participant dataSharing planned: Yes. Requests for the IPD can be made to the Prof Weiya Zhang. Raw de-identified data may be shared
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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.
Weiya Zhang, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical NSAID and Topical Capsaicin in people with Osteoarthritis, Knee, run by University of Nottingham at 1 site in United Kingdom.
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 11 inclusion and 10 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 18 Apr 2019. 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 United Kingdom. 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?
Change from baseline knee pain on 0-10 numeric rating scale (NRS) (time frame: Baseline and end of each treatment period (i.e., after four weeks of treatment)). 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 NCT03146689, which also lists 1 linked publication.
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 18 Apr 2019.