The results of this study indicate the use of the unloading knee brace in combination with usual care as a safe and superior therapy in relieving global pain and improving motion as compared to routine care.

Knee osteoarthritis (OA) refers to a common disabling disorder that leads to considerable pain, immobility, functional impairment and reduced quality of life. It becomes prevalent as the age of the population increases. This medical condition affects one (unilateral) or both (bilateral) knees and may encompass all three joint compartments. The management of knee OA consists of a combination of both pharmacological (analgesics such as acetaminophen, non-steroidal anti-inflammatory drugs [NSAIDs], and intra-articular corticosteroids) and non-pharmacological (exercise programs, self-management and education adaptation of activities, biomechanical interventions like, knee braces, foot orthoses) treatments.

In this randomised controlled clinical trial, the effect of unloading knee braces has been studied to apply corrective forces in an area away from the damaged compartment. These forces are implemented using a three-point pressure system, which distributes load away from the damaged compartment that decreases pain intensity and improves function.

Rationale behind research:

The unloading knee brace therapy can be used to diminish stress and pain across the knee. Pain reduction after brace use can be due to the neutral alignment of the knee and application of three-point pressures, and this research was conducted to clarify the above hypothesis.

Objective:

This study aimed to assess the additive effect of unloading knee brace for adjusting corrective forces, in the conservative treatment of medial OA.

Study outcomes

• The baseline characteristics included assessment of body mass index and pain scores using Kellgren-Lawrence grade
• The primary symptom outcome measure comprises evaluation of global last-24h knee pain relief (measured using a 100-mm VAS) after a 6-week treatment period
• The secondary outcomes include assessment evolution of pain on motion (100-mm VAS), functional disability (Lequesne index), PGIC, CGI-I, responder rate according to OARSI- OMERACT criteria (which defined clinical response as pain decrease [VAS] ≥50% and ≥20 mm or Lequesne index decrease ≥50%), analgesic consumption, safety and acceptability of brace therapy

Time Points: Baseline and 6 weeks

Outcomes:

Baseline: The baseline pain scores and Lequesne index were high, indicating that symptomatic OA was associated with pain and very severe disability

Study outcomes:

• A decrease observed in mean last 24h-pain in Brace group as compared to Control group (−41.35 [3.37] vs −15.37 [3.23], difference −25.98, 95% CI −41.64 to −10.33, P < 0.0001)
• A significantly higher mean [SD] pain on motion decrease (−51.91 [3.49] vs −19.91 [3.34], difference −32.01, 95% CI −48.21 to −15.80, P < 0.0001) was observed in brace group as compared to control group
• There was improvement in Lequesne index score (−5.8 [0.5] vs −2.3 [0.5], difference −3.5, 95% CI −5.0 to −2.0, P < 0.0001) in Brace group as compared to control group
• Safety and observance to brace were acceptable, and the additive clinical benefit of wearing REBEL RELIEVER unloading knee brace was demonstrated in knee OA patients

The results of this trial showed that a combination of the REBEL RELIEVER unloading knee brace with usual care was superior to routine care alone in terms of improvement of the last 24h-pain, pain on motion, disease evolution, functional disability, assessed by both the patient and the investigator, and clinical response rate after a 6-week treatment period. Consistency has been observed among previously published data and the study results, suggesting that treatment with unloader braces improves pain and physical function. A significant decrease in knee adduction impulse (KAI) and peak knee adduction moment (KAM) in the second half of the stance phase was also observed at both 2 and 8 weeks compared to baseline. A reduction of more than 40 mm last 24h-pain score on a 100-mm VAS and 50 mm in pain on motion score in the Brace Group compared to baseline. The OMERACT-OARSI responder rate was 75%, which is superior to that observed in previous clinical trials with other products to reduce pain and improve function in medial knee osteoarthritis patients.

The key strengths of this study are the robustness of its design (randomised, comparative study, objective endpoints, data collection methods, missing data [MD] handling, and ITT analysis). Additional strengths of the ROTOR study were the excellent observance of the brace (observance index >90%) and the low number of drops-out.