Efectivness of Spa Therapy in Efectivness of Spa Therapy in Severe Knee Osteoarthritis; Severe Knee Osteoarthritis; Randomize Controlled TrialRandomize Controlled Trial

Mine Karagülle,MDMine Karagülle,MDIstanbul, Turkey Istanbul, Turkey

ObjectiveObjective

We aimed to determine effectiveness of We aimed to determine effectiveness of spa therapy during short and long term on spa therapy during short and long term on pain and function in severe knee pain and function in severe knee osteoarthritisosteoarthritis

Study DesignStudy Design

ProspectiveProspective RandomizedRandomized ControlledControlled Assessor blindedAssessor blinded Follow-up 6 monthFollow-up 6 month A pilot study 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 measurementsBefore Spa Therapy, at end of

spa therapy 3 and 6 months

9 completed the study1 patient lost to 3 and 6 month follow up

Outcome measurementsAt the same time pointsin outpatients polyclinic

8 patients completed the study2 patients lost to 6 month follow up

Study GroupsStudy Groups Spa Group (Spa Group (n:1n:100) )

Spa Therapy:Spa Therapy:10-day stay at spa 10-day stay at spa hotel hotel Süzer Paradise Süzer Paradise Hotel, Alaçatı, İzmirHotel, Alaçatı, İzmir

Control Group Control Group (n:(n:1010) ) Routine outpatient Routine outpatient care: care: drug therapy drug therapy (NSAID’s and (NSAID’s and Paracetamol) and Paracetamol) and counseling at counseling at Outpatient Clinic Outpatient Clinic Istanbul Medical Istanbul Medical FacultyFaculty

PatientsPatients Spa GroupSpa GroupN:10N:10

Control GroupControl GroupN:10N:10

AgeAge mean mean (SD)(SD), , Female/MaleFemale/Male

5577.3 (.3 (±11.2±11.2) ) 88/2/2

662.2.77 ( (±± 8.4) 8.4)9/19/1

Duration of disease Duration of disease year, mean year, mean

222,2,44 223.33.3

Radiological gradeRadiological grade(L(Laawrencewrence && KeKelllgrelgrenn))

II. 6 patientII. 6 patientIII. 4 patientIII. 4 patient

II. 7 patientII. 7 patientIII. 3 patientIII. 3 patient

Drug therapyDrug therapy NSAID and NSAID and paracetamol paracetamol as neededas needed

NSAID and NSAID and paracetamol as paracetamol as prescribed prescribed

Spa TherapySpa Therapy

• BalneotherapyBalneotherapy• MassageMassage• Milieu changeMilieu change• RestRest• Free activities Free activities • NSAID and analgesic as needed, NSAID and analgesic as needed,

changes were noted by patientschanges were noted by patients

Spa TherapySpa Therapy BBalneotalneothheraperapy; y;

Thermomineral water (brine; % 3 NaCl)Thermomineral water (brine; % 3 NaCl) Twice daily (one in the morning and one in the Twice daily (one in the morning and one in the

afternoon)afternoon) 30 minutes duration30 minutes duration 36-37ºC36-37ºC thermal pool bathing thermal pool bathing 4 patients total 4 patients total 2200 baths baths 4 patients total 19 baths 4 patients total 19 baths 2 patients total 18 baths 2 patients total 18 baths

Spa TherapySpa Therapy

Massage; Massage; 4 patients = 4 patients = nonenone 3 patients = 3 patients = 5 times5 times 3 patients = 1 times3 patients = 1 times

Spa TherapySpa Therapy

Drug use; Drug use; 1 patient NSAID 1 patient NSAID 1 patient paracetamol 1 patient paracetamol

Spa TherapySpa Therapy

Other Uncontrolled Factors;Other Uncontrolled Factors; RestingResting MilieMilieu changeu change Regular daily ritmRegular daily ritm

Routine outpatient careRoutine outpatient care

NSAID’sNSAID’s ParacetamolParacetamol Medical adviceMedical advice

Outcome Outcome MMeasureseasures

Lequesne Knee indexLequesne Knee index WOMAC OA indexWOMAC OA index Pain (VAS)Pain (VAS) Patient’s gPatient’s globallobal assessment (VAS) assessment (VAS) Physician’sPhysician’s global global assessment (VAS)assessment (VAS) 10 step ascending time (second)10 step ascending time (second) 15m walking time (second)15m walking time (second) 3 times squatting time (second)3 times squatting time (second)

Outcome Outcome MeMeasuresasures

BaselineBaseline End of spa therapy (2 - 3 days later)End of spa therapy (2 - 3 days later) Long term Long term

33 month month 66 month month

Lequesne Knee İndexLequesne Knee İndex

02

4

6

8

10

12

14

B 15 D 3.M 6.MSpa Control

Significant improvement Significant improvement in spa group at the end of in spa group at the end of spa therapy, at 3 and 6 spa therapy, at 3 and 6 monthmonth

Significant improvementSignificant improvementin control group only at 6 in control group only at 6 month (per protocol month (per protocol analyse)analyse)

NNo significant difference o significant difference at 6 month at 6 month between two between two groupsgroups

xx

xP:0,0004 P:0,006P:0,03

xx

x P:0,01

WOMAC-totalWOMAC-total

0

10

20

30

40

50

60

70

B 15 D 3. M 6. M

Spa Control

Significant Significant reduction reduction of of WOMAC scoresWOMAC scores in spa in spa group at all assessmentsgroup at all assessments

SSpa group pa group is superior is superior at at end ofend of spa therapy and 3 spa therapy and 3 month compared to month compared to control groupcontrol group

Significant Significant reductionreduction in in control group control group onlyonly at 6 at 6 monthmonth (per protocol (per protocol analyse)analyse)

x

xP:0,04

x

x

P:0,01

x x

P:0,01

10 Step Ascending Time (sc)10 Step Ascending Time (sc)

0

5

10

15

20

25

30

B 15 D 3. M 6. M

Spa Control

Significant Significant improvement in spa improvement in spa group at end of spa group at end of spa therapy and 3 month therapy and 3 month

Worsening in control Worsening in control group is not significantgroup is not significant

No difference between No difference between two study groups two study groups

P:0,03 P:0,04

xx

x

15m walking time (sc)15m walking time (sc)

0

5

10

15

20

25

B 15 D 3. M 6.M

Spa Control

Improvement in spa Improvement in spa group, significant at end of group, significant at end of spa therapy and 3 monthspa therapy and 3 month

No significant change in No significant change in control group control group

Spa group is significantSpa group is significantlyly superior at 3 month superior at 3 month compared to control compared to control group, no difference at 6 group, no difference at 6 monthmonth

P:0,03 P:0,01

xxx

P:0,01

x

x

3 times squatting time (sc)3 times squatting time (sc)

0

5

10

15

20

25

30

35

B 15 D 3 M 6 M

Spa Control

IImprovement in spa mprovement in spa groupgroup at all measures, at all measures, ssignificant at 6 monthignificant at 6 month

Worsening in control Worsening in control group, not significantgroup, not significant

Spa group is superior Spa group is superior to control groupto control group, , significant significant at 3 month at 3 month (per protocol analyse)(per protocol analyse)

x

P:0,01

xx

x

Pain-VASPain-VAS

0

10

20

30

40

50

60

70

B 15 D 3 M 6 M

Spa Control

Significant reduction in Significant reduction in spa group at all spa group at all assessments assessments

Significant Significant increaseincrease in in control group at 3 control group at 3 monthmonth

Spa group is superior in Spa group is superior in reducing pain reducing pain significantly at the significantly at the eend nd of spa therapy and 3 of spa therapy and 3 monthmonth, no significant , no significant differencedifference at 6 mothat 6 moth

x

x

x

xp:0,01 p:0,001

p:0,02

x

x

Patient’s Global AssessmentsPatient’s Global Assessments

0

10

20

30

40

50

60

70

B 15 D 3 M 6 M

Spa Control

Improvement in spa Improvement in spa group group at all assessmentsat all assessments,, significant at 3 and 6 significant at 3 and 6 monthsmonths

No significant change in No significant change in control groupcontrol group

Spa group is Spa group is ssignificantignificantlyly superior in improvement superior in improvement at 3 month compared to at 3 month compared to control groupcontrol group

x

xP:0,01

PPhysician’s global assessmentshysician’s global assessments

0

10

20

30

40

50

60

70

B 15 D 3 M 6 M

Spa Control

SignificantSignificant improvement improvement inin spaspa group group at all at all measurementsmeasurements

SSignificant superiority ignificant superiority in in spa group spa group over routine over routine therapy group at end of therapy group at end of spa therapyspa therapy, and 3 and 6. , and 3 and 6. monthsmonths

SignificantSignificant improvement improvement in control group only at 6 in control group only at 6 month (per protocol month (per protocol analyse)analyse)

X

X X

X

P:0,01 P:0,02

P:0,04

X

X

X X

P:0,04

ConclusionConclusion

In this pilot study we showed that 10 days In this pilot study we showed that 10 days spa therapy is effective in short and spa therapy is effective in short and medium term up to 6 month in reducing medium term up to 6 month in reducing pain and improving function of the patients pain and improving function of the patients with severe osteoarthritis of the kneewith severe osteoarthritis of the knee

ConclusionConclusion

Inter group comparison showed that spa Inter group comparison showed that spa therapy group is superior to control group therapy group is superior to control group in most outcome measuresin most outcome measures

Routine out patient care haRoutine out patient care hass limited limited efficacy in reducing pain and improving efficacy in reducing pain and improving function in patients with severe function in patients with severe osteoarthritisosteoarthritis

ConclusionConclusion

This type of spa therapy could be used as This type of spa therapy could be used as an adjunct or an alternative treatment an adjunct or an alternative treatment modality to routine outpatient care in modality to routine outpatient care in patients with severe knee osteoarthritispatients with severe knee osteoarthritis

However, it is needed further well However, it is needed further well designed randomised controlled clinical designed randomised controlled clinical trials with a higher number of patients trials with a higher number of patients having sufficient statistical powerhaving sufficient statistical power

Further Further perspectivesperspectives

Investigating the population effectiveness Investigating the population effectiveness and cost-effectiveness of this kind of spa and cost-effectiveness of this kind of spa therapy is to be determined in further therapy is to be determined in further studiesstudies

Effectiveness of this kind of spa therapy in Effectiveness of this kind of spa therapy in delaying the delaying the joint replacement surgeryjoint replacement surgery should also be determinedshould also be determined