Session Information
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: To demonstrate the non-inferiority of “Active” compared to “Standard” spa therapy at 6 months in symptomatic knee osteoarthritis (KOA) care.
Methods: Prospective, randomized, monocenter, non-inferiority trial with community-based recruitment of KOA patients. Inclusion criteria were: KOA according to the ACR criteria, pain VAS> 3 on a 0-10 scale, and Kellgren and Lawrence (KL) grade ≥2. “Standard” spa” comprised 18 days of standardized spa treatment, 6 days a week for 3 weeks. “Active spa” included iterative spa sessions, 3 days a week for 3 weeks, followed by a dedicated rehabilitation program, 3 days a week for 3 weeks. The primary endpoint was achievement of a minimal clinically important improvement (MCII) for pain VAS, and/or a MCII for function on WOMAC function subscale and no knee surgery, at 6 months (composite MCII). The secondary endpoints were composite MCII at 3 months and achievement of Patient Acceptable Symptoms States (PASS) for pain and function.
Results: Of 283 participants (mean age 64.3 (9.0) years, 181 (66.8%) women, 181(79.7%) bilateral OA, 151 (58.5%) KL grade III or IV), 145 were allocated to Standard spa and 138 to Active spa. Non inferiority could not be demonstrated for the primary endpoint at 6 months: difference of responders -0.01 90%CI [-0.18 to 0.02], p=0.14; number of patients achieving composite MCII: 86 (66.2%) and 66 (57.9%) in the Standard and Active spa group respectively. However, difference between the 2 groups was neither significant for the same criteria (p=0.18). At 3 months, active spa group was not inferior to standard spa group with composite MCII outcome criteria. The number of patients achieving PASS increased from baseline to 3 months and then decreased at 6 month (table). All the analyses using PASS criteria showed non-inferiority of the active spa group at six months.
|
Standard spa N=145 |
Active spa N=138 |
Difference of responders |
P (non -inferiority) |
||||||
| Definition of responder |
N |
(%) |
N |
(%) |
|
[IC 90%] |
|||
| 3 months | Composite MCII |
76 |
(56.3) |
75 |
(70.1) |
0.14 |
(0.04 to 0.24) |
<.0001 |
|
| 6 months | Composite MCII |
86 |
(66.2) |
66 |
(57.9) |
-0.08 |
(-0.18 to 0.02) |
0.14 |
|
| Before Spa | PASS for pain |
13 |
(9.8) |
18 |
(15.1) |
0.05 |
(-0.02 to 0.12) |
<.0001 |
|
| 3 months | PASS for pain |
54 |
(44.6) |
66 |
(66.0) |
0.21 |
(0.11 to 0.32) |
<.0001 |
|
| 6 months | PASS for pain |
51 |
(44.0) |
47 |
(45.6) |
0.02 |
(-0.09 to 0.13) |
<.0001 |
|
Conclusion: Active spa can reasonably be proposed to patients with KOA. Such protocol could be more cost-effective while allowing benefiting spa therapy without absenteeism from work or avoiding accommodation costs for patients living close to the centre.
To cite this abstract in AMA style:
Rat AC, Loeuille D, Spitz E, Desvignes A, Boulange M, Paysant J, Guillemin F, Chary-Valckenaere I. Comparison of Spa Therapy with or without Physical Rehabilitation for Knee Osteoarthritis: A Randomized Controlled Trial [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/comparison-of-spa-therapy-with-or-without-physical-rehabilitation-for-knee-osteoarthritis-a-randomized-controlled-trial/. Accessed .« Back to 2016 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/comparison-of-spa-therapy-with-or-without-physical-rehabilitation-for-knee-osteoarthritis-a-randomized-controlled-trial/