Combination exercise therapy and pain medication in patients with knee OA.|
|- candidate number||15650|
|- NTR Number||NTR4231|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-nov-2013|
|- Secondary IDs||NL44276.048.13 METC |
|- Public Title||Combination exercise therapy and pain medication in patients with knee OA.|
|- Scientific Title||Exercise therapy in combination with optimal pain-relieving medication in patients with osteoarthritis of the knee and severe knee pain: a feasibility study.|
|- hypothesis||Exercise therapy reduces pain and improves daily functioning in patients with osteoarthritis. Patients with severe knee pain caused by osteoarthritis may benefit insufficiently, because they exercise at a suboptimal level. On account of a new developed intervention protocol, which combines exercise therapy with pain medication, it is expected that this group of patients will be able to participate in exercise therapy, in order to reduce pain and improve daily functioning in patients with severe knee pain. This study will test the feasibility of the intervention protocol. This intervention protocol will be feasible if 50% of the patients participate in the exercise therapy program. Every patient will participate in at least 80% of the exercise therapy sessions, at a level high enough to expect physiological improvements. If the intervention protocol seems feasible, a continuation of this study will be planned as an randomized controlled trial. After this study the intervention protocol will possibly be embedded in regular care. |
|- Healt Condition(s) or Problem(s) studied||Pain, Knee osteoarthritis|
|- Inclusion criteria||- Diagnosis of knee OA according to ACR-criteria: knee pain and at least 3 of the following 6 items: age > 50 years, morning stiffness<30 minutes, crepitations, bone sensitivity, bony enlargement of the joint margin, no palpable warmth|
- NRS knee pain during community walking °›7
- The indication for rehabilitation involves improvement of knee-related functioning
|- Exclusion criteria||- Age <= 18 years|
- Scheduled knee surgery within the next 6 months
- Total knee prosthesis at the non-involved side with pain or limitations
- Exercise therapy in the last six months
- Absolute contra-indication for use of pain-relieving medication
- Absolute contra-indication for exercise therapy
- Psychoneuroticism (Symptom Checklist 90 (SCL-90) score > 150)
- Insufficient control over the Dutch language
- No informed consent
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jun-2013|
|- planned closingdate||1-sep-2014|
|- Target number of participants||50|
|- Interventions||Based on literature and expert opinion, the intervention protocol has been developed. The intervention protocol describes a medication protocol and an exercise protocol. The medication protocol is based on the WHO analgesic ladder and the Beating OsteoARTritis (BART) strategy for stepped care in hip and knee OA. The exercise protocol is the STABILO exercise therapy protocol. This protocol has shown good results and is based on the guideline of the Royal Dutch Association of Physical Therapy (KNGF) for OA of the hip and knee.
The medication protocol contains a medication diagram which describes the steps in the prescription of pain-relieving drugs (i.e. paracetamol, NSAID, weak opioids and intra-articular steroid injection). The transition to the next step in the medication diagram will be taken if there is inadequate pain relief (NRS-pain during walking or exercise therapy>5). The steps to be taken, and the combination and dosage of pain-relieving drugs will be determined by the treating rheumatologist, depending on known risk factors, contra-indications and recent previous experiences of the patient with the prescribed drugs (e.g. intolerance). After 6 weeks of establishing pain-relieving medication exercise therapy will be started under supervision of a physiotherapist. Pain will be recorded during exercise therapy and medication can be adjusted by the rheumatologist during exercise therapy based on these pain recordings (aiming at NRS-pain during therapy °‹ 5). If necessary blood laboratory will be performed.
The exercise protocol begins six weeks after the start of the medication protocol and consists a period of strength training followed by functional training. The functional training is based on the individual aims, which have been described before the start of the training by the patient. Also, daily home exercises will be prescribed. The exercise protocol describes exercises in sessions of one hour twice a week during 12 weeks that will be performed in groups of maximal four patients. Every exercise session has a distinct aim and is written out per session. To optimize exercise intensity, individual tailored exercise adaptations will be performed by a physical therapist.
|- Primary outcome||Feasibility: Participating in the STABILO exercise therapy program|
Activity limitations: Western Ontario and Mc Master Universities Osteoarthritis Index; physical function subscale
|- Secondary outcome||Feasiblity:|
- details of the interviews with patients, rheumatologists and physiotherapists: Medication usage, exercise therapy content, load (time, medication, physical), suggestions for improvement of the protocol, difference with regular care, feasibility of the intervention protocol, adherence, deviations from the intervention protocol, adverse events,
communications between health professionals
- during the intervention protocol details of: NRS-pain during exercises and walking, borg score during exercises, exercise content and intensity, medication use, adverse events, adherence
Pain: Numeric Rating Scale for pain (NRS-pain), Measure of Intermittent and Constant OsteoArthritis Pain, Western Ontario and Mc Master Universities Osteoarthritis Index; pain subscale
Activity limitations: Timed Get Up and Go, Stair Climbing Test
Muscle Strength of the knee extensors: Isokinetic muscle strength
Physical activity level: LASA Physical Activity Questionnaire
|- Timepoints||During the 18 weeks of the intervention protocol details about pain, adherence, medication and exercise therapy are collected. Additionally, after the intervention period, semi-structured open question interviews are held with patients, rheumatologists and physical therapists.
Measurements of pain, activity limitations, and muscle strength take place at baseline (T0), after six weeks of incremental pain medication (T1), and after twelve weeks of exercise therapy (T2).
* Knee pain
- Numeric Rating Scale (0-10) for pain during community walking (NRS-pain walking) for the last 48 hours is completed to include patients and on T0, T1 and T2.
- Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire is completed by the patients on T0, T1 and T2.
- Western Ontario and Mac Masters Universities Osteoarthritis Index (WOMAC) pain subscale is completed on T0, T1 and T2.
* Activity limitations
- Western Ontario and Mac Masters Universities Osteoarthritis Index (WOMAC) physical function subscale (primary outcome) is completed on T0, T1 and T2.
- Timed Get Up and Go test (TUG) is completed on T0, T1 and T2.
- Stair climbing test is completed on T0, T1 and T2.
* Muscle strength of the knee extensors
- Isokinetic muscle strength (En-Knee) is measured on T0, T1 and T2.
* Physical activity level
- LASA Physical Activity Questionnaire (LAPAQ) is completed on T0, T1 and T2.
|- Trial web site||www.reade.nl/mex-oa|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Msc Joyce van Tunen|
|- CONTACT for SCIENTIFIC QUERIES||Msc Joyce van Tunen|
|- Sponsor/Initiator ||Reade, VU University Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background: The already high prevalence of osteoarthritis (OA) will increase the next decades due to its relation with age and obesity. Exercise therapy is recommended to reduce pain and improve physical function in patients with OA. Patients with severe knee pain may benefit insufficiently, because of the ineffective level of exercise. The combination of pharmalogical and non-pharmalogical treatment is recommended in guidelines, but there is limited scientific evidence for this combination.
The intervention protocol developed by our study group combines a medication protocol and an exercise protocol. The medication protocol contains a medication diagram, in which medication prescription is based on inadequate pain relief. There is large experience with the exercise protocol, which shows positive results in patients with knee OA. The aim of this intervention protocol is to allow patients with severe knee pain to participate in exercise therapy after optimal pain relief by the use of pharmalogical treatment. We expect that patients with severe knee pain will be able to exercise at a level for being effective in improving daily functioning.
Study aims: The first study aim is to test the feasibility of the new intervention protocol which combines exercise therapy and painrelieving medication. Currently it is impossible for patients with severe knee pain to participate in exercise therapy programs. Therefore, our aim is to allow 50% of the patients to participate in an exercise therapy program. The second aim is to test whether the application of an optimal combination and dosage of pain-relieving medication together with exercise therapy will reduce pain in patients with knee OA and severe knee pain (NRS-pain walking°›7) and will improve their ability to perform activities of daily living.
Methods: This study will be performed as a feasibility study. Fifty patients with severe knee pain (Numeric Rating Scale for pain (NRS-pain)>7) will follow the intervention protocol. During the first six weeks of the intervention protocol a stepwise increase in pain medication will be established dependent on NRS-pain during community walking>5. After these six weeks the exercise therapy protocol of 12 weeks will be started. Medication will be increased dependent on NRS-painduring exercise therapy>5.
During the 18 weeks of the intervention protocol details about pain, adherence, medication and exercise therapy are collected. Additionally, after the intervention period, semi-structured open question interviews are held with patients, rheumatologists and physical therapists. Measurements of pain, activity limitations, and muscle strength take place at baseline (T0), after six weeks of incremental pain medication (T1), and after twelve weeks of exercise therapy (T2).
Patient recruitment will take place in the Netherlands.
|- Main changes (audit trail)|
|- RECORD||1-nov-2013 - 16-jan-2015|
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