None listed
Conditions
Brief summary
Providing effective treatment for osteoarthritis is challenging. Both non-steroidal anti-inflammatory medication (NSAIDs) and physiotherapy are effective treatments for people with knee OA, but it is unclear whether combining the two provides additional benefit. We aim to investigate clinical and cost effectiveness of this combined intervention in a future double blind randomised controlled trial (RCT). This feasibility trial is proposed to establish the acceptability and safety of the intervention and trial procedures, test participant recruitment and screening, and accurately estimate the cost of conducting the full RCT. Additionally, serum biomarkers of inflammation will be investigated to explore their association to the clinical signs and symptoms of knee OA, and their responsiveness to treatment.
Interventions
Two arm trial
Both arms receive a 12-week pragmatic evidenced-based physiotherapy intervention incorporating aerobic exercise, resistance exercise, neuromuscular co-ordination exercise, passive joint mobilisation techniques, mobilisations with movement, education on knee osteoarthritis and advice to stay active and control body weight. Physiotherapy treatment will be tailored to the individual participant, based on their impairments, with the dose designed to physiologically change tissues, and
Two arm trial Both arms receive a 12-week pragmatic evidenced-based physiotherapy intervention incorporating aerobic exercise, resistance exercise, neuromuscular co-ordination exercise, passive joint mobilisation techniques, mobilisations with movement, education on knee osteoarthritis and advice to stay active and control body weight. Physiotherapy treatment will be tailored to the individual participant, based on their impairments, with the dose designed to physiologically change tissues, and regularly progressed. Treatment is delivered by a New Zealand (NZ) registered physiotherapist on an individual basis for 4-6 sessions in the first 4 weeks, and as weekly group exercise sessions in the following 8 weeks. There will be approximately 6 people in each group, and participants will exercise at moderate intensity, self-rated using the Borg rating of perceived exertion (RPE) scale. Treatment sessions will be between 30-60 minutes duration, and will take place in person at the School of Physiotherapy, Dunedin, NZ. Adherence to the trial protocol will be checked by regular audit of treatment notes. Participants will also have a home exercise and physical activity programme, which they will be asked to complete for the whole 12 weeks on days when they do not attend treatment. The aim is to complete between 150-180 minutes of physical activity per week. Adherence will be recorded in an exercise log. Prescribed exercises will include muscle strengthening for lower limb muscles, for example isometric quadriceps setting, squats and straight leg raise. There will also be range of motion and stretching exercises; for example active knee flexion and extension, and hamstring stretch or gastrocnemius stretch. Aerobic physical activity will be promoted such as walking, swimming or cycling. Exercises will be tailored to the individual with starting dose prescribed to promote engagement and limit flare-ups, and regularly progressed to promote physiological changes in tissues. One arm of the trial will receive the active intervention. The active intervention is 1000mg of naproxen, a non-COX2 specific non-steroidal anti-inflammatory drug (NSAID); and 20 mg of omeprazole, a proton pump inhibitor (PPI). This is delivered orally on a daily basis for 4-weeks, and on an as need basis for the following 8 weeks. Use of medication will be monitored using a medication diary, and by return of unused medications and packaging. The physiotherapist providing the physiotherapy intervention will ask regularly about medication use during the first 4 weeks, and the home exercise programme over the whole 12 weeks, to promote adherence to the trial protocol.
Sponsors
Dr Cathy Chapple
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 45 years or over, with activity-related joint pain and morning stiffness less than or equal to 30 minutes. Participants should have pain on most days in the last month (>15 days), at a minimum of 4 out of 10 on a numeric rating scale in the past week.
Exclusion criteria
• Comorbidities precluding safe participation in moderate exercise or safe prescription of NSAIDs including: uncontrolled or severe hypertension, cardiac arrhythmia, uncontrolled cardiovascular disease, chronic respiratory disease, including asthma, unstable diabetes, chronic gluco-corticosteroid treatment, or short term gluco-corticosteroid treatment at any dose within last 6 weeks prior to study, heart failure (NYHA Class II or above), a history of peptic ulcer, osteoporosis (diagnosed by DEXA scan and requiring regular medication), chronic kidney disease (Stage 3B or above). • Following screening, people with a higher risk of GI or CV events, or any risk of renal compromise will be excluded. • People will be excluded if their estimated glomerular filtration rate (e-GFR) is below 75mls/min , or their Hb less than 115g/L. • The study GP will utilise routine clinical decision-making to evaluate people with low or moderate risk of GI or CV events, taking into account other clinical and demographic information to determine eligibility for safe participation in the trial. • Specialist/surgical consultation for OA or on waiting-list for knee surgery • Inflammatory arthritis (e.g. Rheumatoid Arthritis or psoriatic arthritis), including gout affecting the knee or on urate lowering medication (Allopurinol) • Recent intra-articular injection of knee with corticosteroid or physiotherapy treatment (in previous six months) • Pain medication dependence, including regular prescribed NSAIDs • Prescribed regular PPI • Previous intolerance or allergy to NSAIDs • Anti-coagulant medication.
Outcome results
None listed