None listed
Conditions
Brief summary
This study will investigate the frequency of manual therapy treatment for people with knee osteoarthritis (OA). The hypothesis is that frequency of treatment will influence patient outcomes. It is a feasibility study with a small number of participants that will not be able to determine if frequency does influence outcome, but will evaluate whether there is justification for conducting a similar large scale randomised controlled trial. It will evaluate study procedures, and acceptability as well as provide data to calculate how big a future trial may need to be. This will be a three-arm intervention study with two intervention groups and one control group. Ten participants will be randomly assigned to each group. Group A: standardized intervention, manual therapy to the knee, one 45 minute session per week for six weeks, at a targeted treatment interval of seven days. (Six treatments). Two further treatment sessions of 45 minutes each, to teach an individualised home exercise programme, and to progress the programme. These will take place after the follow-up assessments at six weeks and six months. Group B: standardized intervention, manual therapy to the knee, two 45 minute sessions per week for three weeks (six treatments). Target treatment interval will be three or four days. Two further treatment sessions of 45 minutes each, to teach an individualised home exercise programme, and to progress the programme. These will take place after the follow-up assessments at three weeks and six months. Group C (control): Two treatment sessions of 45 minutes each, to teach an individualised home exercise programme, and to progress the programme. These will take place after the follow-up assessments at six weeks and six months. Standardized intervention (minus manual therapy) will also be delivered in these two sessions. Standardised intervention will include education about OA and general recommended advice regards self-management, such as control of body weight, and maintenance of regular exercise. Manual therapy includes physiotherapist-generated techniques to mobilise the knee joint and stretch soft tissues. These techniques are commonly used in routine physiotherapy practice. Outcome will be measured at three weeks, six weeks, and six months to evaluate symptoms such as pain, stiffness and function, knee movement, physical performance, and feasibility of study design and processes.
Interventions
Manual therapy provided by a physiotherapist at a frequency of once per week for six weeks or twice per week for three weeks. For the once per week group, the target treatment interval will be seven days (minimum six days, maximum nine days). For the twice per week group intervals between treatments will be three or four days (minimum two days, maximum five days). Reasons for not booking appointments on the target day will be recorded, as will the reasons for selection of an alternative day within the acceptable range. If appointments cannot be scheduled within the acceptable range, they will be recorded as "missed", with a reason. Each manual therapy treatment session will last for 45 minutes and include mobilisation of joints by the physiotherapist, and stretching applied to the soft tissues. During the sessions the physiotherapist will deliver a standardised information package including education about osteoarthritis, and advice such as control of body weight and maintenance of regular exercise. This will be done as per usual practice of conversing with the participant as treatment is performed, and will include a summary at the end of the session. The participants will be encouraged to repeat back the information to ensure they have understood it, and will also be given a flyer containing the same information. On completion of the course of manual therapy, participants will be prescribed an individualised home exercise programme in line with best practice for osteoarthritis. They will attend for an additional 45 min treatment session following either the three week or six week assessment, depending on group allocation. The physiotherapist will teach the exercise programme and check the performance of the exercises by the participant. The programme will be multi modal and include aerobic, strengthening, stretching and neuromuscular coordination exercises. Participants will be advised to perform the home exercise programme two to three times per week, and should be completed in 20-30 mins. Following six month follow-up assessment, the home exercise programme will be checked for accuracy of performance, difficulty due to pain, or exercises becoming too easy. Participants will be asked to estimate how often per week they completed the home exercise programme. When participants have improved their strength, flexibility or general fitness, exercises will be progressed to ensure they are still tailored to produce therapeutic benefit.
Sponsors
Study design
Eligibility
Inclusion criteria
Adults (greater than 18yrs) with persistent knee pain meeting the clinical classification criteria for knee osteoarthritis (ACR) . In addition the nominated knee must lack full extension (at least 5 degrees loss of extension).
Exclusion criteria
Previous lower limb joint arthroplasty, lower limb injury/surgery/knee osteoarthritis (OA) treatment in previous 12 months, consultation with orthopaedic specialist for knee OA, or commencement of new medication for OA (previous 1 month); other forms of arthritis, plus comorbidities that will preclude safe application of manual therapy.