Ibuprofen Gel or Capsaicin Cream for my Painful Knee Osteoarthritis?

NCT ID: NCT03146689

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-04
• Study Completion Date: 2018-10-16

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Topical NSAID and topical capsaicin

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).

Group Type: EXPERIMENTAL

Topical NSAID

Intervention Type: DRUG

Applied four times daily

Topical Capsaicin

Intervention Type: DRUG

Applied four times daily

Interventions

Topical NSAID

Applied four times daily

Intervention Type: DRUG

Topical Capsaicin

Applied four times daily

Intervention Type: DRUG

Other Intervention Names

Ibuprofen 5% gel; Zacin 0.025% cream

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

Exclusion Criteria

• 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
• Current treatment for stomach or duodenal ulcers
• Total joint replacement of affected joint
• Renal failure
• Taking anticoagulants

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthritis Research UK Pain Centre

UNKNOWN

Sponsor Role: collaborator

Nottingham University Hospitals Charity

UNKNOWN

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weiya Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

Academic Rheumatology, University of Nottingham

Nottingham, Nottinghamshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33197270 (View on PubMed)

Other Identifiers

B 10022017

Identifier Type: -

Identifier Source: org_study_id