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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Knee Osteoarthritis | Other: Muscle Strengthening TrainingBehavioral: Behavioral graded activity | Not Applicable |
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Go to| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 90 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | The patients will be randomly allocated to 12 weeks of either muscle strengthening training (MST), behavioural graded activity (BGA) or control. Randomization will be performed by using the method of randomly permuted blocks, utilising a computer-generated random number sequence. To keep both intervention groups balanced, randomization will be stratified for sex (male versus female) baseline inflammation status (hsCRP<3mg/L versus hsCRP ≥3mg/L) and baseline central sensitization status (central sensitization inventory (CSI) score <40 versus CSI score ≥ 40). A list with patient numbers and the group allocation that results from this randomization procedure will be securely stored and only an independent researcher will have direct access to the randomization list. Patients will be scheduled to receive their first assessment within 1 week of randomisation. Patients will be recruited in primary care and participating hospitals. Announcements will be placed in newspapers, pharmacies etc. |
| Masking: | Triple (Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Outcome assessors will be blinded to the maximal extent possible. With regard to this, patients will be asked not to communicate with the assessors about the intervention received. The researcher who is responsible for the acute measurements, is not blinded for group allocation but the researcher responsible for the basal measurements is. Both researchers are blinded for the outcome analyses. Furthermore, at the end of each assessment, the success of assessor blinding will be examined by asking whether the assessor thought the participant had received the experimental or control intervention, including the percentage of certainty. The physiotherapists providing BGA will not be involved in providing MST, and vice versa. Additionally, the physiotherapists will be blinded for outcome measures. The statistician will be blinded to the allocation of the treatment groups and statistical analyses will be performed in a blinded manner. |
| Primary Purpose: | Basic Science |
| Official Title: | Exercise Therapy for Osteoarthritis Pain: How Does it Work? |
| Actual Study Start Date : | January 10, 2020 |
| Estimated Primary Completion Date : | December 31, 2022 |
| Estimated Study Completion Date : | December 31, 2022 |
