Erdal Dilekçi1, Kağan Özkuk2, Barış Kaki3. 1. Department of Physical Medicine and Rehabilitation, Izzet Baysal Physical Medicine and Rehabilitation Training and Research Hospital, Bolu, Turkey. Electronic address: erdaldilekci@gmail.com. 2. Department of Medical Ecology and Hydroclimatology, Usak University Faculty of Medicine, Uşak, Turkey. Electronic address: kagan.ozkuk@usak.edu.tr. 3. Department of Econometrics, Usak University Faculty Of Economics And Administrative Sciences, Uşak, Turkey. Electronic address: baris.kaki@usak.edu.tr.
Abstract
OBJECTIVE: This study aimed to compare whether there are positive effects of balneotherapy(BT) on pain, quality of life and disability of individuals receiving physical therapy(PT) for chronic low back pain and to examine the effect of body mass index(BMI) on treatment. MATERIALS AND METHOD: This prospective, controlled, single blind study was conducted. Patients were randomized into two groups through a simple randomization in a 1:1 ratio. The clinician and biostatistics expert were blinded. PT group was applied PT, BT + PT group was applied PT + BT. All patients were included in the study for 3 weeks (total of 15 sessions, 5 days per week). All patients applied hot pack, transcutaneous electrical nerve stimulation and ultrasound. Patients in the BT + PT group applied BT in thermo mineralized water pool (20 min at 38-40 °C). Assessments were made using Pain-Visual Analog Scale(VAS), EQ-5D-3 L Scale(EQ5), EQ-VAS, Functional Assessment of Chronic Illness Therapy-Fatigue(FACIT-F), Roland-Morris Disability Questionnaire(RMDQ) and Quebec Back Pain Disability Scale(QBPDS) at the beginning (W0) and end (W3) of treatment. While performing statistical analysis, patients were divided into 3 categories of BMI1(18.5-24.9 kg/m2), BMI2 (25.0-29.9 kg/m2) and BMI3(≥30.0 kg/m2). RESULTS:270 patients were randomized. 129 patients in PT group and 133 patients in PT + BT group completed the study. In the BT + PT group, there were increases in the EQ5 and EQ-VAS variables and decreases in all other variables compared to the PT group which were found to be statistically significant (for QBPDS p < 0.05, the others p < 0.01). The differences in all variables W0 and W3 were at least half reductions and increases which were found to be statistically significant (p < 0.01). In terms of BMI, there were significant differences for all groups, especially BMI3 had higher means for all variables apart from EQ5 and EQ-VAS than the other two categories. BMI1 was the BMI category with highest means for EQ5 and EQ-VAS. The Group × Time interaction was found to be statistically significant for Pain-VAS, EQ5, EQ-VAS, FACIT-F, QBPDS and RMDQ(p < 0.01). For Pain-VAS, the effect of the Group × Time × BMI interaction was found to be statistically significant(p < 0.05). CONCLUSION:BT plus PT was more effective than PT. BT may have positive contributions to reducing pain, functionality of patients, quality of life, fatigue and disability status.
RCT Entities:
OBJECTIVE: This study aimed to compare whether there are positive effects of balneotherapy(BT) on pain, quality of life and disability of individuals receiving physical therapy(PT) for chronic low back pain and to examine the effect of body mass index(BMI) on treatment. MATERIALS AND METHOD: This prospective, controlled, single blind study was conducted. Patients were randomized into two groups through a simple randomization in a 1:1 ratio. The clinician and biostatistics expert were blinded. PT group was applied PT, BT + PT group was applied PT + BT. All patients were included in the study for 3 weeks (total of 15 sessions, 5 days per week). All patients applied hot pack, transcutaneous electrical nerve stimulation and ultrasound. Patients in the BT + PT group applied BT in thermo mineralized water pool (20 min at 38-40 °C). Assessments were made using Pain-Visual Analog Scale(VAS), EQ-5D-3 L Scale(EQ5), EQ-VAS, Functional Assessment of Chronic Illness Therapy-Fatigue(FACIT-F), Roland-Morris Disability Questionnaire(RMDQ) and Quebec Back Pain Disability Scale(QBPDS) at the beginning (W0) and end (W3) of treatment. While performing statistical analysis, patients were divided into 3 categories of BMI1(18.5-24.9 kg/m2), BMI2 (25.0-29.9 kg/m2) and BMI3(≥30.0 kg/m2). RESULTS: 270 patients were randomized. 129 patients in PT group and 133 patients in PT + BT group completed the study. In the BT + PT group, there were increases in the EQ5 and EQ-VAS variables and decreases in all other variables compared to the PT group which were found to be statistically significant (for QBPDS p < 0.05, the others p < 0.01). The differences in all variables W0 and W3 were at least half reductions and increases which were found to be statistically significant (p < 0.01). In terms of BMI, there were significant differences for all groups, especially BMI3 had higher means for all variables apart from EQ5 and EQ-VAS than the other two categories. BMI1 was the BMI category with highest means for EQ5 and EQ-VAS. The Group × Time interaction was found to be statistically significant for Pain-VAS, EQ5, EQ-VAS, FACIT-F, QBPDS and RMDQ(p < 0.01). For Pain-VAS, the effect of the Group × Time × BMI interaction was found to be statistically significant(p < 0.05). CONCLUSION: BT plus PT was more effective than PT. BT may have positive contributions to reducing pain, functionality of patients, quality of life, fatigue and disability status.
Authors: Maria Chiara Maccarone; Hiroharu Kamioka; Sara Cheleschi; Sara Tenti; Stefano Masiero; Sinan Kardeş Journal: Environ Sci Pollut Res Int Date: 2021-06-29 Impact factor: 4.223