Transcript Document

Efectivness of Spa Therapy in
Severe Knee Osteoarthritis;
Randomize Controlled Trial
Mine Karagülle,MD
Istanbul, Turkey
Objective
 We
aimed to determine effectiveness of
spa therapy during short and long term on
pain and function in severe knee
osteoarthritis
Study Design
 Prospective
 Randomized
 Controlled
 Assessor
blinded
 Follow-up 6 month
 A pilot study
Study Diagram
Patients with knee osteoarthritis (ACR OA Criteria)
Assessment in Musculoskeletal Polyclinic of Department of MEHC
37 patients examined and evaluated
according to the ACR inclusionon criteria
20 patients performed inform consent and
they randomized 2 groups
10 Patients Spa therapy group,
Alaçatı, Süzer Hotel
10 Patients Control group
Routine therapy at outpatient polyclinic
Outcome measurements
Before Spa Therapy, at end of
spa therapy 3 and 6 months
Outcome measurements
At the same time points
in outpatients polyclinic
9 completed the study
1 patient lost to 3 and 6 month follow up
8 patients completed the study
2 patients lost to 6 month follow up
Study Groups

Spa Group (n:10)
Spa Therapy:
10-day stay at spa
hotel Süzer Paradise
Hotel, Alaçatı, İzmir

Control Group (n:10)
Routine outpatient
care:
drug therapy
(NSAID’s and
Paracetamol) and
counseling at
Outpatient Clinic
Istanbul Medical
Faculty
Patients
Spa Group
N:10
Control Group
N:10
Age mean (SD),
Female/Male
57.3 (±11.2)
8/2
62.7 (± 8.4)
9/1
Duration of disease
22,4
year, mean
Radiological grade
II. 6 patient
(Lawrence & Kellgren) III. 4 patient
23.3
Drug therapy
NSAID and
paracetamol as
prescribed
NSAID and
paracetamol
as needed
II. 7 patient
III. 3 patient
Spa Therapy
•
•
•
•
•
•
Balneotherapy
Massage
Milieu change
Rest
Free activities
NSAID and analgesic as needed,
changes were noted by patients
Spa Therapy
 Balneotherapy;
Thermomineral water (brine; % 3 NaCl)






Twice daily (one in the morning and one in the
afternoon)
30 minutes duration
36-37ºC thermal pool bathing
4 patients total 20 baths
4 patients total 19 baths
2 patients total 18 baths
Spa Therapy
 Massage;



4 patients = none
3 patients = 5 times
3 patients = 1 times
Spa Therapy
 Drug


use;
1 patient NSAID
1 patient paracetamol
Spa Therapy
 Other



Uncontrolled Factors;
Resting
Milieu change
Regular daily ritm
Routine outpatient care
 NSAID’s
 Paracetamol
 Medical
advice
Outcome Measures
 Lequesne
Knee index
 WOMAC OA index
 Pain (VAS)
 Patient’s global assessment (VAS)
 Physician’s global assessment (VAS)
 10 step ascending time (second)
 15m walking time (second)
 3 times squatting time (second)
Outcome Measures
 Baseline
 End
of spa therapy (2 - 3 days later)
 Long term


3 month
6 month
Lequesne Knee İndex
14
12

P:0,0004 P:0,03 P:0,006
x
x
P:0,01
10
x
8
x
x
x

6
4

2
0
B
15 D
Spa
3.M
6.M
Control
Significant improvement
in spa group at the end of
spa therapy, at 3 and 6
month
Significant improvement
in control group only at 6
month (per protocol
analyse)
No significant difference
at 6 month between two
groups
WOMAC-total

Significant reduction of
WOMAC scores in spa
group at all assessments

Spa group is superior at
end of spa therapy and 3
month compared to
control group

Significant reduction in
control group only at 6
month (per protocol
analyse)
P:0,04 P:0,01
x
x
P:0,01
70
x
60
x
50
x
x
40
30
20
10
0
B
15 D
Spa
3. M
Control
6. M
10 Step Ascending Time (sc)
P:0,03
P:0,04

Significant
improvement in spa
group at end of spa
therapy and 3 month

Worsening in control
group is not significant

No difference between
two study groups
30
25
x
x
20
x
15
10
5
0
B
15 D
Spa
3. M
Control
6. M
15m walking time (sc)
P:0,03
P:0,01
P:0,01

Improvement in spa
group, significant at end of
spa therapy and 3 month

No significant change in
control group

Spa group is significantly
superior at 3 month
compared to control
group, no difference at 6
month
25
x
20
x
x
xx
15
10
5
0
B
15 D
Spa
3. M
Control
6.M
3 times squatting time (sc)
P:0,01

Improvement in spa
group at all measures,
significant at 6 month

Worsening in control
group, not significant

Spa group is superior
to control group,
significant at 3 month
(per protocol analyse)
35
x
30
25
20
x
x
10
x
15
5
0
B
15 D
Spa
3M
Control
6M
Pain-VAS

p:0,02
70
x
p:0,01
60
x
x
50
p:0,001
x
40
x
30

x
20
10
0

B
15 D
Spa
3M
Control
6M
Significant reduction in
spa group at all
assessments
Significant increase in
control group at 3
month
Spa group is superior in
reducing pain
significantly at the end
of spa therapy and 3
month, no significant
difference at 6 moth
Patient’s Global Assessments

P:0,01
70
x
60
50

x
40
30

20
10
0
B
15 D
Spa
3M
Control
6M
Improvement in spa
group at all assessments,
significant at 3 and 6
months
No significant change in
control group
Spa group is significantly
superior in improvement
at 3 month compared to
control group
Physician’s global assessments
P:0,04

P:0,01 P:0,02
70
X
X
60
X
X
50
X
40
X
X

P:0,04
X
30
20

10
0
B
15 D
Spa
3M
Control
6M
Significant improvement
in spa group at all
measurements
Significant superiority in
spa group over routine
therapy group at end of
spa therapy, and 3 and 6.
months
Significant improvement
in control group only at 6
month (per protocol
analyse)
Conclusion
 In
this pilot study we showed that 10 days
spa therapy is effective in short and
medium term up to 6 month in reducing
pain and improving function of the patients
with severe osteoarthritis of the knee
Conclusion
 Inter
group comparison showed that spa
therapy group is superior to control group
in most outcome measures
 Routine out patient care has limited
efficacy in reducing pain and improving
function in patients with severe
osteoarthritis
Conclusion
 This
type of spa therapy could be used as
an adjunct or an alternative treatment
modality to routine outpatient care in
patients with severe knee osteoarthritis
 However, it is needed further well
designed randomised controlled clinical
trials with a higher number of patients
having sufficient statistical power
Further perspectives
 Investigating
the population effectiveness
and cost-effectiveness of this kind of spa
therapy is to be determined in further
studies
 Effectiveness of this kind of spa therapy in
delaying the joint replacement surgery
should also be determined