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BÁLINT G, ÁDÁM A, RATKÓ I, SOMOS É, POÓR
L,BÁLINT P, TEFNER I, BENDER T.Budapest,
Hungary


DOUBLE
BLIND STUDY ABOUT THE EFFECTIVITY OF THE THERMAL
MINERAL WATER OF NAGYBARACSKA IN PATIENT WITH
KNEE JOINT OSTEOARTHRITIS
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AIMS OF THE STUDYTO STUDY THE EFFECT OF THE
THERMAL MINERAL WATER OF NAGYBARACSKA ON THE KNEE
PAIN AND MOBILITY OF PATIENTS WITH MILD AND
MODERATE OSTEOARTHRITIS OF THE KNEE.
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mg / l
N2 531 K 35 NH4
6,7 Ca 219 Mg 65 Fe
1,89 Mn 0,08 Li 0,46
Kations 879,00 Cl - 443 Br - 0,89 J -
0,78 F - 2,8 HCO3 1.458.0 NO2 - NO3
- Anions 1.931.00 Free CO2 864.00 Total
3.722.00
THE CONTENT OF THE MINERAL WATER OF NAGYBARACSKA
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INCLUSION CRITERIA - FEMALE AND MALE PATIENTS
WITH THE AGE BETWEEN 5O-75 YEARS - FEMALE
PATIENTS IN MENOPAUSE - PAIN CHARACTERISTIC OF
KNEE JOINT OA FOR AT LEAST 3 MONTHS - FULFILLIN
G THE ACR CRITERIA FOR OA OF THE KNEE - NOT
HAVING SYSTEMATIC OR LOCAL STEROID TREATMENT,
ANY KIND OF PHYSIOTHERAPY (WITH THE EXCEPTION
OF HOME-EXCERCISES) IN THE LAST TWO
MONTH - ALL THE PATIENTS MUST HAVE A-P X-RAY
FILMS OF BOTH KNEES NOT OLDER THEN ONE YEAR
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EXCLUSION CRITERIA  - NOT FULFILLING THE
INCLUSION CRITERIA - ANY PREVIOUS KNEE JOINT
OPERATION -  ANY HIP JOINT OR SPINE OPERATION
WITHIN ONE YEAR BEFORE THE STUDY  -  ANY
TRAUMA OF ONE OF THE KNEE JOINTS WITHIN ONE YEAR
BEFORE THE STUDY -  ARTHROSCOPY OF THE KNEE
JOINT WITHIN 3 MONTHS BEFORE THE STUDY  -
INTRAARTICULAR HYALURONAN INJECTION WITHIN 2
MONTHS BEFORE THE STUDY - PATIENTS WITH
LUMBAR RADICULOPATHY  - PATIENTS WITH PALPABLE
BAKER CYST  - SEDIMENTATION RATE HIGHER, THEN
30 mm IN FEMALES AND HIGHER THEN 20 mm IN
MALES  - PATIENTS WITH SEVERE INTERNAL
UROGENITAL RHEUMATOLOGICAL OR ANY OTHER
DISEASES CONTRAINDICATING BALNEOTHERAPY  -
NON-COMPLIANT, AND PSYCHO-NEUROROTIC PATIENTS
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ALL THE PATIENTS WERE INFORMED ABOUT THE AIM AND
THE DETAILS OF THE STUDY BEFORE SCREENINGS AND
ALL GAVE THEIR WRITTEN CONSENT. THE STUDY WAS
PERMITTED BY THE LOCAL AND REGIONAL ETHICAL
COMMITTEE
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COURSE OF THE STUDY32-32 PATIENTS SCREENED AND
SELECTED FOR THE STUDY WERE RANDOMLY ALLOCATED
EITHER IN THE BALNEOLOGY OR THE CONTROLL GROUPS
BY ONE OF THE AUTHORS. (L.P)
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1 . FIGURE MEAN AND SD OF THE AGE OF THE
PATIENTS
80
70
60
50
40
30
20
10
0
TAP WATER GROUP
THERMAL-MINERAL WATER GROUP
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3 . FIGURE MEAN AND SD OF TOTAL WOMAC
SCORES BEFORE TREATMENT
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4 . FIGURE DISTRIBUTION OF GENDERS IN THE TAP
WATER AND TERMAL-MINERAL WATER GROUP
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ALL THE ASSESSEMENTS BEFORE AND AFTER THE STUDY
WERE PERFORMED BY ONE OF THE AUTHORS. (É.S.)
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THE STUDY GROUP RECEIVED 30 MINUTES INDIVIDUAL
THERMAL MINERAL WATER TREATMENT IN TUBS, 5
TIMES A WEEK FOR 4 WEEKS. THE CONTROLL GROUP
RECEIVED 30 MINUTES INDIVIDUAL TAP WATER
TREATMENT HEATED UP TO THE TEMPERATURE OF THE
THERMAL WATER IN THE SAME ARRANGEMENT.
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THE ASSESSING PHYSICIAN (É.S) PERFORMED DETAILED
HISTORY TAKING DETAILED PHYSICAL EXAMINATION
RANGE OF MOVEMENTS OF
THE KNEES ASCERTAINING THAT THE PATIENT IS
FULFILLING THE INCLUSION CRITERIA AND PRESENTING
NO EXCLUSION CRITERIA
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- ASCERTAINED THE FILLING OUT OF THE WOMAC
SCORE- REGISTERING OF THE SIDE EFFECTS-
REGISTRATION OF THE USE OF EXTRA ANALGESICS-
PHYSICIANS OPINION ABOUT THE RESULT OF THE STUDY
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ASSESSEMENTS WERE PERFORMED - BEFORE THE
STUDY- IMMEDIATELY AFTER FINISHING OF THE
STUDY- 3 MONTHS AFTER FINISHING THE STUDY
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THE STUDY DOCTOR (A.Á)  INQUIRED ABOUT THE
GENERAL STATUS AND KNEE PAIN OF THE PATIENT
MEASURED PULSE RATE AND BLOOD PRESSURE INQUIRED
ABOUT SIDE EFFECTS AND USE OF EXTRA ANALGESICS
DURING THE STUDY, TWICE A WEEK.  NEITHER THE
ASSESSING NOR THE RANDOMIZING, AND THE STUDY
DOCTOR OR ANY PERSONS WERE AWARE OF THE TYPE OF
TREATMENT THE PATIENTS RECEIVED, WITH EXCEPTION
OF THE BALNEO-TECHNICIAN, BUT HE WAS ASKED TO
KEEP IT IN SECRET.
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RESULTSFROM THE THERMAL-MINERAL WATER GROUP 5
PATIENTS FROM TH E TAP WATER GROUP 7 PATIENTS
DID NOT FINISH THE TRIAL
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 REASONS FOR FALLING OUT 
THERMAL-MINERAL TAP WATER GROUP
WATER GROUPACUTE FEBRILE


CONDITION 1 3 HYPERTENSION 1
1 FAMILY AFFAIRS 1
2 UNKNOWN 2 1ALLTOGETHER 5
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 IN THE THERMAL MINERAL WATER GROUP 27
(10 ?, 17 ?)IN THE TAP WATER GROUP 29 ( 9 ?,
16 ?) PATIENTS FINISHED THE TRIAL AND THEIR
RESULTS WERE ANALYSED. THE TWO GROUPS WERE
COMPARABLE.
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TAP WATER GROUP
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THERMAL-MINERAL WATER GROUP
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SUMMARY THE WOMAC ACTIVITY AND TOTAL SCORE
IMPROVED SIGNIFICANTLY EVEN IN THE TAP WATER
GROUP AT THE AND OF THE TRIAL, BUT THERE WAS NO
SIGNIFICANT IMPROVEMENT AFTER 3 MONTHS COMPARED
TO THE VALUES MEASURED BEFORE THE
TREATMENT.ALL THE WOMAC SCORES, AND ALSO THE
WALKING DISTANCE IMPROVED SIGNIFICANTLY IN THE
THERMAL MINERAL WATER GROUP BOTH AT THE END OF
THE TREATMENT AND AFTER THREE MONTHS. NO
CONSIDERABLE SIDE EFFECTS OCCURED, THERE WAS NO
EXTRA USE OF ANALGESICS IN EITHER GROUP.
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