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Revista chilena de pediatría

versión impresa ISSN 0370-4106

Rev. chil. pediatr. vol.90 no.3 Santiago jun. 2019

http://dx.doi.org/10.32641/rchped.v90i3.886 

ORIGINAL ARTICLE

Effectiveness of Watsu therapy in patients with juvenile idiopathic arthritis. A parallel, randomized, controlled and single-blind clinical trial

Natalia Pérez Ramírez1  2 

Paula Nahuelhual Cares2 

Pamela San Martín Peñailillo2 

1Kinesiology Unit, Teletón Institute, Santiago of Chile, Chile.

2Direction of Research and Development - Teletón Chile, Chile.

Abstract:

Introduction:

Juvenile idiopathic arthritis (JIA) is a rheumatologic disease in children under 16 years old, which causes early physical disability. The use of hydrotherapy Watsu in these patients is propo sed.

Objective:

To evaluate the effectiveness of Watsu compared to conventional hydrotherapy on health-related quality of life (HRQoL), functional health status, pain, and ranges of joint motion in patients with acute or subacute JIA.

Patients and Method:

Randomized (1:1) single-blind parallel controlled clinical trial in 46 patients with acute and subacute JIA between 8-18 years old. Pediatric Quality of Life Inventory 4.0 (PedsQL4.0), Childhood Health Assessment Questionnaire (CHAQ), and 10-joints Global range of motion score (GROMS) assessments were used at the beginning, post treatment, and after three months of follow-up. Patients were randomly assigned to the Watsu group (n = 24) and to the conventional hydrotherapy group (n = 22), participating in 10 sessions of 45 mi nutes once a week.

Results:

Watsu therapy showed statistically significant improvements in physical functioning-HRQoL (p = 0.041), disability index (p = 0.015), distress index (p = 0.015), and functio nal health status-CHAQ (p = 0.013) after treatment compared to conventional hydrotherapy.

Con clusions:

Watsu therapy improved HRQoL, pain sensation, and functional health status compared to conventional hydrotherapy. Methodological adaptations are required in future studies to improve the external validity of these results.

Keywords: Juvenile Idiopathic Arthritis; Autoimmune Diseases; Rehabilitation; Hydrotherapy; Watsu

Introduction

Juvenile idiopathic arthritis (JIA) is the most com mon rheumatic disorder in childhood and it appears as a persistent inflammation of one or more joints in children under 16 years of age for a period longer than 6 weeks1-4.

This disease has seven independent entities: Sys temic arthritis, polyarticular with rheumatoid factor, polyarticular with negative rheumatoid factor, oligoarticular (persistent or extended), enthesitis-related arthritis, psoriatic arthritis, and undifferentiated ar thritis, which appears with different forms of presen tation, clinical signs, and symptoms, laboratory tests and genetic basis2,5-7. This situation makes it difficult to diagnose and treat early, which can lead to premature physical disability due to the presence of severe joint damage in the first two years of illness1,2. This damage is accompanied by muscle weakness, pain, decreased joint mobility, and limitations in daily activities4,8,9. However, early treatment can decrease and prevent this situation1,10.

The main objective of therapeutic interventions in children and adolescents with JIA is to achieve clinical remission, along with preventing structural damage and the onset of symptoms, maintaining good functio nal ability, and promoting physical and psychological well-being1,3,11.

The achievement of these objectives requires an in tegral and multidisciplinary approach, which includes pharmacological interventions (non-steroidal anti-in flammatory drugs, corticosteroids, disease-modifying drugs, biological agents, among others), and integral rehabilitation1,3,6. This rehabilitation seeks to educate the patient and family, control pain and inflammatory status, maintain joint ranges of motion, muscle stren gth, physical condition, and adequate psychological status, along with reintegrating the child with JIA into their occupational and recreational activities1, with di fferent health professionals participating in this pro cess.

In the physical therapy area for JIA, the use of hy drotherapy is recommended due to its positive effects on joint range of motion, pain, and inflammation con trol during the acute phase1,10,12,13, and improvement in muscle strength, function, cardiovascular condition, social interaction, and independence in the subacute and remission phases10. Its mechanism of action is ba sed on the physical properties of water (buoyancy, viscosity, thermal conductivity, and hydrostatic pressure) that facilitate joint movement, promote muscle relaxa tion, control the inflammatory process, and diminish the pain sensation14,15.

In 2008, a systematic review was published on the effects of exercise in patients with JIA16, where impro vements were observed without statistical significance in functionality, quality of life, joint range of motion, aerobic capacity, and the number of swollen joints. Regarding hydrotherapy, only one study showed sta tistically significant results in reducing the number of inflamed joints17, however, the used treatment proto cols focused on active muscle exercises, stretching, and play18 which are limited in children with pain in the acute or subacute phase.

In these children, it is proposed to use an aqua tic relaxation therapy called Watsu (Water-Shiatsu), which consists of passive movement sequences, mus cle stretching and massages during assisted immersion in warm water19,20; however, this therapy has not pre viously been used in this population.

Studies with limited evidence have described the use of Watsu in people with stroke20, cerebral palsy21, and fibromyalgia22,23; which was effective in the latter in reducing pain, improving depression22 and health- related quality of life (HRQoL)23.

In this context, this randomized controlled clinical study is conducted to evaluate the effectiveness of Wat- su therapy in improving HRQoL, functionality, joint range of motion and pain sensation in a population of children and adolescents diagnosed with acute or sub acute JIA compared to conventional hydrotherapy.

Patients and Method

Study design

It is a randomized controlled clinical trial, of pa rallel groups, with ratio 1:1 and simple blind, that was approved by the Scientific Ethical Committee of the Sociedad Pro Ayuda del Niño Lisiado - Teletón (Certi ficate N° 7/2012).

Participants

The patient population was determined by sear ching the database and reviewing clinical records, of which patients diagnosed with JIA at the Teleton Insti tute (TI) Santiago were included in the study between 2012 and 2015, aged 8 to 18, in the acute or subacute phase (given by sensation of pain, joint swelling, and functional deficit during the last three months befo re the intervention), who had a medical indication for hydrotherapy and who agreed to participate in the study by signing a consent by the child and informed consent by the legal guardian.

Patients who presented the following symptoms before the start of the study were excluded: sensation of pain, swelling or functionality limitation due to ex ternal causes to JIA (surgeries or trauma), intercurrent diseases (respiratory diseases, inflammatory disease of the ear, skin lesions, and infections), urinary and/or in testinal incontinence, and fear of water.

Interventions

This study considered two parallel groups, pre viously randomized, where the study group received a Watsu therapy protocol and the control group recei ved a conventional hydrotherapy protocol. Both pro tocols had a duration of 10 sessions, once a week, with 45-minute sessions.

a) Watsu: The patients received a protocol of passive movement sequences, stretches, and massages, be longing to the “Transition Flow” of Watsu thera py19 (Table 1).

Table 1 Group treatment Watsu and conventional hydrotherapy protocols. 

b) Hydrotherapy: The patients received a hydrothe rapy protocol for arthritis, adapted from the proposal of Epps et al.18, consisting of stretching, strengthening exercises, and swimming (Table 1).

In both groups, the treatment was carried out by physiotherapist with experience in rehabilitation of physically disabled people at TI Santiago. In the case of Watsu therapy, the therapist had 163 hours of practical training, certified by the Institut fur Aquatische Kor- perarbeit (IAKA) and the Chilean Aquatic Bodywork Federation.

60% or more adherence to the total scheduled treatment in each patient was considered as accom plished treatment. In addition, the continuity of their routine treatments was accepted, such as scheduled admissions to regular physiotherapy, occupational thera py, and changes in their pharmacological dosage due to ethical considerations.

Outcome measures

HRQoL, functional health status, sensation of pain, and joint ranges of passive motion were evaluated in both groups in the previous, subsequent and 3-month follow-up periods. The professionals in charge of carrying out the measurements were a psychologist and two physiotherapists trained in the use of each evalua tion instrument.

Main outcome

Health-related quality of life: The Pediatric Qua lity of Life Inventory Scale (PedsQL 4.0 Generic Core Scale) was used, which measures HRQoL in people aged 2 to 18, healthy or with a chronic health condi tion, and it is validated for the Chilean population24. This scale evaluates the child’s physical, emotional, so cial, and school performance domains25, giving a 0 to 100% HRQoL score.

Secondary outcomes

a) Functional health status: Defined as the effect of JIA on the ability to perform common tasks9 and measured through the Childhood Health As sessment Questionnaire (CHAQ). This question naire is used in patients with JIA between 1 and 19 years of age26, validated in Chile in 200127. It has a disability index (which contains questions of functionality in daily activities), discomfort, and health status. The results were turned into a score from 0 to 3 which is translated into absence of di sability or maximum functional disability respectively(26, 27).

b) Sensation of pain: Pain was measured by the dis comfort index present in CHAQ26. This initially used a numeral scale from 0 to 100 (from no pain to maximum pain) to represent the perceived sen sation of pain, which was then changed into a score from 0 to 3 of the global questionnaire.

c) Joint ranges of motion: The 10-joints Global Ran ge of Motion Scale (GROMS) was used, which evaluates 10 passive movements considered essen tial for functionality, such as elbow flexion, wrist extension, general mobility of proximal metacar pophalangeal and interphalangeal joints (from the second to the fifth finger), thumb flexion and ab duction, hip flexion-extension, and knee flexion- extension. It uses a score from 0 to 1, where 1 is normal joint range in all 10 joints(28, 29). However, this scale has not been used previously in clinical studies, but its creators state that its results would be related to those obtained in CHAQ28.

Sample size

It was not determined since we used the total po pulation of patients with JIA from the TI Santiago who met the inclusion criteria and agreed to participate in the study.

Randomization

a) Sequence generation: A simple randomization method was performed in groups of 10 patients, with ratio 1:1, after accepting to participate in the study.

b) Assignment concealment mechanism: The patient’s personal information was hidden using an identi fication code (ID), then assigned to the Watsu and conventional hydrotherapy groups using a ran dom number generator (nosetup.org). This infor mation was put into sealed envelopes, which were given to the patient and/or legal guardian.

Implementation

The methodological team of the Research and De velopment Administration Teletón performed the se quence of random assignment and interventions, and the principal investigator carried out the registration of participants.

Blinding

The evaluators who performed each outcome mea surement (pre-intervention, post-intervention, and follow-up) were blind to randomization and assign ment of participants to study groups. However, given the evident differences in interventions (Watsu and conventional hydrotherapy), patients and physiothe rapists who administered the therapies were not blin ded.

Statistical methods

The data were recorded in an Excel spreadsheet and processed using the statistical software SPSS v17.0. Summary measures were calculated for study variables, Student’s T-test was used for means, and Pearson’s chi-square to determine differences in age, gender, and type of JIA between groups.

Shapiro-Wilk normality test was performed. Va riables comparisons between groups were made using Kruskal-Wallis and Mann-Whitney tests, and varia bles differences within each study group at baseline, post-treatment and follow-up were analyzed with Friedman and Wilcoxon tests. P<0.05 was considered a statistically significant difference. Data were analy zed on an ‘intention-to-treat’ basis, so the dependent variables of all randomized patients were included in the analysis.

Results

Participant flow

231 JIA patients aged 8-18 years were found in the TI Santiago database (2012-2015), and 59 of them met the inclusion criteria. Out of these, 46 agreed to parti cipate and signed informed consent and/or assent, and then were assigned by simple randomization in Watsu (n = 24) and hydrotherapy (n = 22).

During the intervention process, five cycles of para llel treatment were carried out, between June 2013 and December 2015, concluding the intervention phase at the end of 2015, due to the lack of new patients who met the inclusion criteria.

In the 2013-2015 period, 16 patients interrupted their treatment (34.78% of total loss) due to the pre sence of intercurrent diseases, scheduling problems, and family issues (Figure 1). This recorded loss in both the Watsu group (n = 8; 33% loss) and conven tional hydrotherapy (n = 8; 36% loss) did not pre sent statistically significant intergroup differences (p = 0.537).

Figure 1 Diagram of the flow of patients during the execution of the ran domized clinical trial (Ba sed on CONSORT, 2010). 

Clinical and demographic characteristics

The study participants presented homogeneity bet ween the Watsu and hydrotherapy groups, in terms of age and subtype of JIA. The mean age was 13.17 ± 3.02 years for the Watsu group and 12.68 ± 3.00 years for the conventional hydrotherapy group, without statis tically significant intergroup differences (p = 0.880). According to JIA subtype, there was a greater presen ce of polyarticular JIA (26.1%), undifferentiated JIA (26.1%), and oligoarticular JIA (19.6%) in the total number of participants and no significant differences were observed in the intergroup analysis (p = 0.454).

On the other hand, most of the study participants were female (76.1%), however, there were statisti cally significant differences (p = 0.038) in grouping patients by gender in the study groups, with a higher number of males concentrated in the Watsu group. (Table 2).

Table 2 Clinical and demographic baseline characteristics of the study groups. 

Main result

Regarding health-related quality of life measured through PedsQL4.0, Watsu therapy presented a sta tistically significant difference in the physical functio ning sub-dimension at basal level (p = 0.028), and a statistically significant post-intervention improvement (p = 0.041) compared to conventional hydrotherapy.

In the intra-group evaluation, Watsu therapy ob tained significant differences in improvement in the psychosocial health sub-dimension between baseline evaluation and follow-up (p = 0.021). Conventional hydrotherapy showed no significant intra-group di fferences in sub-dimensions or overall quality of life scores (Table 3).

Table 3 Health-related quality of life (HRQoL) in each study group measured with Pediatric Quality of Life Inventory Scale (Peds QL 4.0 Generic Core Scale). 

Secondary results

a) Functional health status and sensation of pain: Upon application of the Childhood Health Assessment Questionnaire (CHAQ), Watsu therapy obtained sta tistically significant improvements in the post-inter vention evaluation of the disability index (p = 0.015), discomfort index (p = 0.031), health status index (p = 0.013), and total CHAQ score (p = 0.003) compa red to conventional hydrotherapy.

In the intra-group evaluation of each CHAQ index, no statistically significant differences were observed in the disability index in the Watsu or hydrotherapy group (Table 4). In the discomfort index, Watsu thera py obtained a statistically significant improvement in post-intervention evaluation (p = 0.007), in contrast, in the health status index, Watsu therapy obtained a statistically significant deterioration between post-in tervention evaluation and follow-up (p = 0.012). On the other hand, the health status index of conventional hydrotherapy showed statistically significant impro vements between post-intervention evaluation and follow-up (p = 0.033), and deterioration between ba seline evaluation and follow-up (p = 0.017).

Table 4 Functional health status (CHAQ), its index (disability, discomfort and health status) and range of motion (GROMS) in each study group. 

Finally, in the CHAQ total value, Watsu thera py showed a statistically significant improvement in functional health status between baseline and post intervention evaluations (p = 0.004) and a statistica lly significant deterioration of the same variable bet ween post-intervention and follow-up evaluations (p = 0.039) (Table 4).

b) Range of motion: In the 10-joints Global Range of Motion Scale (GROMS) evaluation, there were no statistically significant differences between the Watsu and hydrotherapy groups (Pre-intervention p = 0.794; Post-intervention p = 0.190, and follow-up p = 0.383).

In the intragroup evaluation, Watsu therapy sig nificantly improved the range of motion between ba seline and post-intervention evaluation (p = 0.023). (Table 4)

Adverse effects

No adverse events related to therapeutic interven tions were reported by study participants or their legal guardians.

Discussion

Watsu therapy improved the physical functioning sub-dimension of HRQoL (PedsQL4.0), disability index, discomfort, health status, and total functional health status score (CHAQ) in children and adoles cents with acute and subacute JIA.

There was no statistically significant difference bet ween Watsu and conventional hydrotherapy in the as sessment of joint ranges of motion (GROMS).

In the intra-group evaluation, the effectiveness of Watsu therapy presented a variable duration, repre senting immediate improvements post-intervention (GROMS and CHAQ) or during follow-up (psycho social health - PedsQL4.0), in contrast, a deteriora tion was observed in the health status index and total functional health status (CHAQ) during follow-up. This situation can be interpreted as limited effective ness of Watsu only to the intervention period in joint function and ranges of motion, but a long-term im provement in the psychosocial health of the patient.

In the case of conventional hydrotherapy, the va lues of HRQoL and joint ranges of motion did not vary with the intervention, however, the health status index (CHAQ) worsened between baseline and follow-up evaluations, and only improved between post-inter vention and follow-up evaluation, which could indi cate that conventional hydrotherapy based on active and resistance exercises in patients with acute and sub acute JIA may be counterproductive.

Literature advises that any type of treatment aimed at JIA should improve disease activity at three months and achieve its therapeutic goal at six months11. In the case of Watsu, the therapy duration may have been not enough to achieve all the proposed therapeutic objec tives, therefore, it is suggested to increase the therapy duration in future studies aimed at patients with acute or subacute JIA, in order to assess the effectiveness of the intervention in the short, medium and long term.

However, these results should be analyzed with caution, as the target studied population (acute and subacute JIAs) is a smaller percentage of the total JIA patients (25% of the target population), and the pre sence of functional disability and pain generates at the same time more restrictions on patient participation in the study. This is ratified by 34.78% of total loss of patients, mainly due to family problems in the Watsu therapy group and intercurrent disease in the conven tional hydrotherapy group.

Given this situation, there is literature regarding the barriers perceived by parents and patients with JIA to adhere to different therapeutic interventions, which hinder the achievement of positive long-term effects30,31. Favier et al. identified that forgetting to attend therapy, the sensation of pain, and the belief that therapy is not necessary are the main barriers to adherence and that both the use of measurements of these barriers and actions that facilitate adherence are vital to achieving a better quality of life in these patients31.

Regarding the clinical and demographic characteri zation of the study population, a higher number of wo men was observed in both groups, which is related to the literature3,7, however, there were differences in the number of men between the Watsu and hydrotherapy groups that did not affect the values resulting from the PedsQL4.032 and CHAQ33 scales.

Concerning the main result, there was a statistica lly significant baseline difference between the Watsu group and hydrotherapy in the physical functioning sub-dimension (PedsQL4.0). The presence of this di fference could be due to the clinical and genetic he terogeneity of the seven subtypes of JIA, favoring this variability. In fact, it is established that JIA is not an individual disease, but a heterogeneous group of disor ders, with differences in their clinical phenotype, cour se of the disease, and pathophysiology11. Given this he terogeneity, it is proposed that future studies consider stratified random sampling by type of JIA and gender rather than simple sampling, as this could decrease the resulting variability.

Finally, we consider that performing a high le vel of evidence study design in a pediatric rheumatic population such as the JIA is a great challenge, given the complexity of meeting the methodological requi rements in terms of feasibility and results generalization34. This is due to JIA is still considered a rare disease given its low prevalence7 and the emphasis on studying the effectiveness of pharmacological therapies mainly through this type of design. In addition, studies using Watsu therapy are scarce and have a low level of evidence20,22,23,35-37, therefore, further research is needed on different biopsychosocial and interdisciplinary stra tegies for intervention in this disease that can promote the control and management of symptoms, along with promoting clinical remission.

Conclusions

Watsu therapy improves HRQoL in the short term related to physical functioning, sensation of pain, di sability index, and functional health status compared to conventional hydrotherapy in patients with acute or subacute JIA.

The limited number of participants and the hetero geneity of their baseline clinical condition hinder the external validity of the study results. For future studies, it is proposed to increase the intervention period with Watsu therapy, to perform randomized sampling stra tified by type of JIA and sex, along with adding ins truments that measure the barriers to adherence to treatment perceived by children and their families, in order to improve the methodological level of the stu dies, promote adherence to treatment, and favor long term remission status.

Ethical Responsibilities

Human Beings and animals protection: Disclosure the authors state that the procedures were followed ac cording to the Declaration of Helsinki and the World Medical Association regarding human experimenta tion developed for the medical community.

Data confidentiality: The authors state that they have followed the protocols of their Center and Local regu lations on the publication of patient data.

Rights to privacy and informed consent: The authors have obtained the informed consent of the patients and/or subjects referred to in the article. This docu ment is in the possession of the correspondence author.

Conflicts of Interest: Authors declare no conflict of interest regarding the present study.

Financial Disclosure: This study was financed with contributions from Teletón - Chile.

Acknowledgments: To Dr. Gurkirpal Singh, Dr. Nicola Ruperto (Pediatric Rheumatology INternational Trials Organization), to the MAPI Research Trust organization (France), to the Direction of Research and Development of Teletón Chile, Archive and Computing Unit, Maintenance Unit and Kinesiology Unit of Teletón Institute in San tiago of Chile.

To Verónica Torres, PT; Yohana Herrera, PT; Carolina Siqués, PT and Israel Valdivia, PT; and the physiatrist Matías Orellana, MD.

In addition to Ms. Susana Palma and Mr. Sergio Valdebenito, for their invaluable help in carrying out this project.

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Received: August 21, 2018; Accepted: December 24, 2018

Correspondence: Natalia E. Pérez Ramírez. E-mail: natalia.e.perez.r@gmail.com, natperez@teleton.cl.

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