A randomised controlled trial of wax baths as an additive therapy to hand exercises in patients with systemic sclerosis

William J. Gregory; Jack Wilkinson; Ariane L. Herrick

doi:10.1016/j.physio.2018.08.008

A randomised controlled trial of wax baths as an additive therapy to hand exercises in patients with systemic sclerosis

William J. Gregory, Jack Wilkinson, Ariane L. Herrick

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Abstract

Objective

The musculoskeletal features of systemic sclerosis (SSc) are a major cause of disability, causing limitations to movement and function. The study aim was to compare the effects of daily hand exercises with or without daily home wax bath hand treatment in patients with SSc.

Design

Assessor-blinded randomised controlled trial of parallel group design.

Setting

Single participating centre, undertaken in secondary care and in participants homes.

Participants

36 participants with hand skin tightening of SSc, two participants lost to follow up.

Interventions

Participants were randomised into wax bath versus no wax bath groups. Both groups in addition performed regular hand exercises as part of standard care. The study period was 9 weeks, with further measures of outcome undertaken at 18 weeks.

Main outcome measures

The primary outcome measure was the Hand Mobility in Scleroderma test (HAMIS). Secondary outcomes measures were the Scleroderma Health Assessment Questionnaire, grip and pinch strength and the Cochin Hand Function Scale.

Results

Between group comparisons of HAMIS scores showed no evidence of effectiveness of the wax bath treatment at 9-week follow up (adjusted difference in means (95% CI) experimental-control −1.47 (−3.55 to 0.61), P = 0.16) or at 18-week follow up (adjusted difference in means (95% CI) experimental-control 1.94 (−1.07 to 4.95), P = 0.20). Analysis of secondary outcomes also showed no evidence for effectiveness of the wax bath treatment at either 9 or 18 weeks.

Conclusion

Our findings suggest that the addition of regular wax bath treatment confers no additional beneficial effect to standard care with daily home exercises.

Original language	English
Pages (from-to)	370-377
Number of pages	8
Journal	Physiotherapy
Volume	105
Issue number	3
Early online date	5 Sept 2018
DOIs	https://doi.org/10.1016/j.physio.2018.08.008
Publication status	Published - 1 Sept 2019

Keywords

Exercise
Physical therapy
Rehabilitation
Systemic sclerosis
Wax baths

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10.1016/j.physio.2018.08.008

SSc Wax Bath FINAL ACCEPTED (with title page abstracts tables and figs)Accepted author manuscript, 207 KB

https://linkinghub.elsevier.com/retrieve/pii/S0031940618302207

Cite this

@article{cabdcf26d1ad4d5f91432362e5043ef8,

title = "A randomised controlled trial of wax baths as an additive therapy to hand exercises in patients with systemic sclerosis",

abstract = "ObjectiveThe musculoskeletal features of systemic sclerosis (SSc) are a major cause of disability, causing limitations to movement and function. The study aim was to compare the effects of daily hand exercises with or without daily home wax bath hand treatment in patients with SSc.DesignAssessor-blinded randomised controlled trial of parallel group design.SettingSingle participating centre, undertaken in secondary care and in participants homes.Participants36 participants with hand skin tightening of SSc, two participants lost to follow up.InterventionsParticipants were randomised into wax bath versus no wax bath groups. Both groups in addition performed regular hand exercises as part of standard care. The study period was 9 weeks, with further measures of outcome undertaken at 18 weeks.Main outcome measuresThe primary outcome measure was the Hand Mobility in Scleroderma test (HAMIS). Secondary outcomes measures were the Scleroderma Health Assessment Questionnaire, grip and pinch strength and the Cochin Hand Function Scale.ResultsBetween group comparisons of HAMIS scores showed no evidence of effectiveness of the wax bath treatment at 9-week follow up (adjusted difference in means (95\% CI) experimental-control −1.47 (−3.55 to 0.61), P = 0.16) or at 18-week follow up (adjusted difference in means (95\% CI) experimental-control 1.94 (−1.07 to 4.95), P = 0.20). Analysis of secondary outcomes also showed no evidence for effectiveness of the wax bath treatment at either 9 or 18 weeks.ConclusionOur findings suggest that the addition of regular wax bath treatment confers no additional beneficial effect to standard care with daily home exercises.",

keywords = "Exercise, Physical therapy, Rehabilitation, Systemic sclerosis, Wax baths",

author = "Gregory, \{William J.\} and Jack Wilkinson and Herrick, \{Ariane L.\}",

note = "Funding Information: Very few RCTs have been carried out in SSc rehabilitation. This study adds to this thin body of research. As standard care, daily home exercises for the hands have been shown to aid hand movement and function [12,15,17,18] . The addition of a wax bath home daily treatment has been shown in this study to have no additional beneficial effect. We are, however, unable to exclude the possibility that certain sub-groups of patients, such as those with early disease, might benefit from the wax bath protocol. The numbers recruited in this study were guided by previous research, and appropriately decided upon from a power calculation with the primary outcome measure. However, numbers were too small for any meaningful subgroup analyses to be performed. Importantly in the planning of future studies aimed at studying specific subgroups, we have shown this protocol of home use wax baths and hand exercise to be tolerable for a representative cohort of patients with SSc. Only one participant temporarily ceased the treatment due to discomfort. The composition of the two participant groups was characteristic of the SSc population as a whole; with male: female ratios and median age range well matched to epidemiological data [2,34] . Both early and late disease stages were represented, with a wide range of disease duration. A strength of the study was that the same physiotherapist performed all assessments through the baseline, 9- and 18- week visits. The results of this study appear in line with previous wax bath SSc research. Whilst a published collection of case studies showed some significant improvements in some outcome measures years ago and studied shorter periods of treatment [12] , all three of the previous controlled trials showed short term benefit, and improvement in certain outcome measures, but overall no convincing clinically important sustained changes. Two of the previous studies were from over 25 [10,11] . Askew et al. in 1983 [10] assessed the effect of a {\textquoteleft}one-off{\textquoteright} physiotherapy intervention for patients with SSc. Pils et al. in 1991 [11] looked specifically at the effect of a series of paraffin wax hand treatments on joint motion. The Askew et al. [10] intervention involved hand and forearm wax bath, friction massages and then active ROM exercises. There were ten participants in the intervention group and seven controls. There is no mention of how well matched the two groups were. The study reported statistically significant improvements for hand ROM; there were improvements in hand dexterity, strength and skin score, but these were all below the level of statistical significance. The post intervention measures were taken two hours after physiotherapy treatment was completed, so longer term impact of this brief physiotherapy treatment cannot be implied [10] . Furthermore when relating the results of this study to our current RCT one could postulate that the improvements may have been due to the hand exercises rather than the wax baths. The Pils et al. [11] study recruited sixteen participants who had daily paraffin wax hand treatment for twelve days. Immediately after the twelve treatments, there was a significant decrease in joint contractures and significant increase in finger ROM, as well as decrease in reported pain levels. The researchers then randomly selected eight of these participants to discontinue wax treatment, whilst the other eight continued with daily treatment. We do not know how well matched these two groups were. During the three months that the control group received no treatment their ROM decreased to pre-intervention levels; whilst the eight patients continuing to receive daily wax treatment maintained their beneficial changes at three month review [11] . The third paraffin wax treatment RCT carried out in 2004 found clinically significant changes in a number of patients in a variety of outcome measures assessed, but a statistically significant change for the group as a whole was only achieved for the finger flexion component of the HAMIS [5] . No statistically significant changes were reported in pain levels, stiffness and elasticity, or grip force. The authors suggested that the HAMIS does not have sufficient sensitivity to identify small changes in ROM [5] . This appears a valid argument as scoring the HAMIS requires a grading of the participant{\textquoteright}s abilities on a scale of zero to three for each of the nine items. Thus a participant could have improved ROM yet still score the same number in the HAMIS assessment. The use of graded outcome measures in the HAMIS does limit the sensitivity to change, with only four options for the participant{\textquoteright}s performance: smaller changes within these four options would not be shown in the results. This limitation applied also in this current study given that the HAMIS was the primary outcome measure. The justification for choosing the HAMIS was that it is a well established outcome measure used in much of the SSc rehabilitation research to date, and that using it would therefore allow appropriate comparison to other studies. The measurement of individual joint ROM or delta finger-to-palm may have given a better chance of detecting change, but it was felt at study design that having a measure that was not included in previous studies of wax for SSc would have been inappropriate because this would have made comparison with other studies difficult. It has been stated that measuring individual joint ROM is time consuming [35] and one can assume this is a strong reason why it is not usually assessed in clinical trials. Delta finger-to-palm was first proposed in the literature in 2010 [35] and therefore was a fairly new measure when the study protocol for this paper was written and had yet to achieve universal uptake. Our study had limitations. The study protocol was devised to be {\textquoteleft}user friendly{\textquoteright} in terms of clinician time and participant visits. It was devised in this way to replicate NHS provision and to enhance participant adherence. With participants often travelling considerable distances to secondary care it is appropriate to look at self-management treatment strategies. We were keen to produce a cost effective programme and the heavy reliance on self-treatment at home and minimal amounts of clinician input have enabled this. However this low level of clinician input is deviant from some of the other RCTs undertaken in rehabilitation for SSc, where a lot more clinician time was utilised [13,15,16,19] . It is well established that the majority of rehabilitation-type interventions cannot be double-blinded by their very nature [36] . The design of this study was single-blinded as it was clear that potential bias of the participant being aware of their intervention allocation could not be avoided. However, we would expect such performance bias to exaggerate the effect of the wax bath, which has not been observed. A post study analysis of the 43 potential participants who declined the study showed no significant differences in demographic or disease data between those included and those who declined to participate. The proportion of potential participants who declined was anticipated (given the long distances some travelled to the clinic) and was similar to previously reported wax SSc study recruitment [5] . Although not limitations for the study per se, it is worth highlighting firstly that the inclusion criterion for mRSS-identified hand and finger skin involvement meant that our cohort was possibly more disabled in their hand movement and function than those studied in other SSc rehabilitation studies. Secondly, the treatment intervention trialled was quite single-faceted yet SSc is a multi-faceted condition. In a systematic review of SSc non-pharmacological interventions the authors noted that multimodal interventions targeting a range of symptoms were used in some studies [9] . The exercise protocol was based on a previous study that showed effect [17] , but could be criticised for not including strengthening or functional rehabilitation exercise components; however it was felt preferable to replicate a previously effective exercise programme. In conclusion, daily home exercises for the hands are well accepted as standard care in patients with SSc. The addition of a wax bath home daily treatment has been shown in this study to have no additional beneficial effect. However, our findings do not exclude the possibility that some subgroups of patients might benefit. Key messages • The musculoskeletal symptoms of SSc are a major cause of disability • Very few RCTs have been carried out in SSc rehabilitation • Wax bath home daily treatment confers no additional beneficial effect to hand exercises alone Ethical approval : By the National Research Ethics Service (Committee North West – Greater Manchester East, 13/NW/0773). Funding : The trial was wholly funded by a research grant from Scleroderma and Raynaud{\textquoteright}s UK . The sponsors had no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication. Conflicts of interest : None declared. Appendix A Publisher Copyright: {\textcopyright} 2018",

year = "2019",

month = sep,

day = "1",

doi = "10.1016/j.physio.2018.08.008",

language = "English",

volume = "105",

pages = "370--377",

journal = "Physiotherapy",

issn = "0031-9406",

publisher = "Elsevier BV",

number = "3",

}

TY - JOUR

T1 - A randomised controlled trial of wax baths as an additive therapy to hand exercises in patients with systemic sclerosis

AU - Gregory, William J.

AU - Wilkinson, Jack

AU - Herrick, Ariane L.

N1 - Funding Information: Very few RCTs have been carried out in SSc rehabilitation. This study adds to this thin body of research. As standard care, daily home exercises for the hands have been shown to aid hand movement and function [12,15,17,18] . The addition of a wax bath home daily treatment has been shown in this study to have no additional beneficial effect. We are, however, unable to exclude the possibility that certain sub-groups of patients, such as those with early disease, might benefit from the wax bath protocol. The numbers recruited in this study were guided by previous research, and appropriately decided upon from a power calculation with the primary outcome measure. However, numbers were too small for any meaningful subgroup analyses to be performed. Importantly in the planning of future studies aimed at studying specific subgroups, we have shown this protocol of home use wax baths and hand exercise to be tolerable for a representative cohort of patients with SSc. Only one participant temporarily ceased the treatment due to discomfort. The composition of the two participant groups was characteristic of the SSc population as a whole; with male: female ratios and median age range well matched to epidemiological data [2,34] . Both early and late disease stages were represented, with a wide range of disease duration. A strength of the study was that the same physiotherapist performed all assessments through the baseline, 9- and 18- week visits. The results of this study appear in line with previous wax bath SSc research. Whilst a published collection of case studies showed some significant improvements in some outcome measures years ago and studied shorter periods of treatment [12] , all three of the previous controlled trials showed short term benefit, and improvement in certain outcome measures, but overall no convincing clinically important sustained changes. Two of the previous studies were from over 25 [10,11] . Askew et al. in 1983 [10] assessed the effect of a ‘one-off’ physiotherapy intervention for patients with SSc. Pils et al. in 1991 [11] looked specifically at the effect of a series of paraffin wax hand treatments on joint motion. The Askew et al. [10] intervention involved hand and forearm wax bath, friction massages and then active ROM exercises. There were ten participants in the intervention group and seven controls. There is no mention of how well matched the two groups were. The study reported statistically significant improvements for hand ROM; there were improvements in hand dexterity, strength and skin score, but these were all below the level of statistical significance. The post intervention measures were taken two hours after physiotherapy treatment was completed, so longer term impact of this brief physiotherapy treatment cannot be implied [10] . Furthermore when relating the results of this study to our current RCT one could postulate that the improvements may have been due to the hand exercises rather than the wax baths. The Pils et al. [11] study recruited sixteen participants who had daily paraffin wax hand treatment for twelve days. Immediately after the twelve treatments, there was a significant decrease in joint contractures and significant increase in finger ROM, as well as decrease in reported pain levels. The researchers then randomly selected eight of these participants to discontinue wax treatment, whilst the other eight continued with daily treatment. We do not know how well matched these two groups were. During the three months that the control group received no treatment their ROM decreased to pre-intervention levels; whilst the eight patients continuing to receive daily wax treatment maintained their beneficial changes at three month review [11] . The third paraffin wax treatment RCT carried out in 2004 found clinically significant changes in a number of patients in a variety of outcome measures assessed, but a statistically significant change for the group as a whole was only achieved for the finger flexion component of the HAMIS [5] . No statistically significant changes were reported in pain levels, stiffness and elasticity, or grip force. The authors suggested that the HAMIS does not have sufficient sensitivity to identify small changes in ROM [5] . This appears a valid argument as scoring the HAMIS requires a grading of the participant’s abilities on a scale of zero to three for each of the nine items. Thus a participant could have improved ROM yet still score the same number in the HAMIS assessment. The use of graded outcome measures in the HAMIS does limit the sensitivity to change, with only four options for the participant’s performance: smaller changes within these four options would not be shown in the results. This limitation applied also in this current study given that the HAMIS was the primary outcome measure. The justification for choosing the HAMIS was that it is a well established outcome measure used in much of the SSc rehabilitation research to date, and that using it would therefore allow appropriate comparison to other studies. The measurement of individual joint ROM or delta finger-to-palm may have given a better chance of detecting change, but it was felt at study design that having a measure that was not included in previous studies of wax for SSc would have been inappropriate because this would have made comparison with other studies difficult. It has been stated that measuring individual joint ROM is time consuming [35] and one can assume this is a strong reason why it is not usually assessed in clinical trials. Delta finger-to-palm was first proposed in the literature in 2010 [35] and therefore was a fairly new measure when the study protocol for this paper was written and had yet to achieve universal uptake. Our study had limitations. The study protocol was devised to be ‘user friendly’ in terms of clinician time and participant visits. It was devised in this way to replicate NHS provision and to enhance participant adherence. With participants often travelling considerable distances to secondary care it is appropriate to look at self-management treatment strategies. We were keen to produce a cost effective programme and the heavy reliance on self-treatment at home and minimal amounts of clinician input have enabled this. However this low level of clinician input is deviant from some of the other RCTs undertaken in rehabilitation for SSc, where a lot more clinician time was utilised [13,15,16,19] . It is well established that the majority of rehabilitation-type interventions cannot be double-blinded by their very nature [36] . The design of this study was single-blinded as it was clear that potential bias of the participant being aware of their intervention allocation could not be avoided. However, we would expect such performance bias to exaggerate the effect of the wax bath, which has not been observed. A post study analysis of the 43 potential participants who declined the study showed no significant differences in demographic or disease data between those included and those who declined to participate. The proportion of potential participants who declined was anticipated (given the long distances some travelled to the clinic) and was similar to previously reported wax SSc study recruitment [5] . Although not limitations for the study per se, it is worth highlighting firstly that the inclusion criterion for mRSS-identified hand and finger skin involvement meant that our cohort was possibly more disabled in their hand movement and function than those studied in other SSc rehabilitation studies. Secondly, the treatment intervention trialled was quite single-faceted yet SSc is a multi-faceted condition. In a systematic review of SSc non-pharmacological interventions the authors noted that multimodal interventions targeting a range of symptoms were used in some studies [9] . The exercise protocol was based on a previous study that showed effect [17] , but could be criticised for not including strengthening or functional rehabilitation exercise components; however it was felt preferable to replicate a previously effective exercise programme. In conclusion, daily home exercises for the hands are well accepted as standard care in patients with SSc. The addition of a wax bath home daily treatment has been shown in this study to have no additional beneficial effect. However, our findings do not exclude the possibility that some subgroups of patients might benefit. Key messages • The musculoskeletal symptoms of SSc are a major cause of disability • Very few RCTs have been carried out in SSc rehabilitation • Wax bath home daily treatment confers no additional beneficial effect to hand exercises alone Ethical approval : By the National Research Ethics Service (Committee North West – Greater Manchester East, 13/NW/0773). Funding : The trial was wholly funded by a research grant from Scleroderma and Raynaud’s UK . The sponsors had no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication. Conflicts of interest : None declared. Appendix A Publisher Copyright: © 2018

PY - 2019/9/1

Y1 - 2019/9/1

N2 - ObjectiveThe musculoskeletal features of systemic sclerosis (SSc) are a major cause of disability, causing limitations to movement and function. The study aim was to compare the effects of daily hand exercises with or without daily home wax bath hand treatment in patients with SSc.DesignAssessor-blinded randomised controlled trial of parallel group design.SettingSingle participating centre, undertaken in secondary care and in participants homes.Participants36 participants with hand skin tightening of SSc, two participants lost to follow up.InterventionsParticipants were randomised into wax bath versus no wax bath groups. Both groups in addition performed regular hand exercises as part of standard care. The study period was 9 weeks, with further measures of outcome undertaken at 18 weeks.Main outcome measuresThe primary outcome measure was the Hand Mobility in Scleroderma test (HAMIS). Secondary outcomes measures were the Scleroderma Health Assessment Questionnaire, grip and pinch strength and the Cochin Hand Function Scale.ResultsBetween group comparisons of HAMIS scores showed no evidence of effectiveness of the wax bath treatment at 9-week follow up (adjusted difference in means (95% CI) experimental-control −1.47 (−3.55 to 0.61), P = 0.16) or at 18-week follow up (adjusted difference in means (95% CI) experimental-control 1.94 (−1.07 to 4.95), P = 0.20). Analysis of secondary outcomes also showed no evidence for effectiveness of the wax bath treatment at either 9 or 18 weeks.ConclusionOur findings suggest that the addition of regular wax bath treatment confers no additional beneficial effect to standard care with daily home exercises.

AB - ObjectiveThe musculoskeletal features of systemic sclerosis (SSc) are a major cause of disability, causing limitations to movement and function. The study aim was to compare the effects of daily hand exercises with or without daily home wax bath hand treatment in patients with SSc.DesignAssessor-blinded randomised controlled trial of parallel group design.SettingSingle participating centre, undertaken in secondary care and in participants homes.Participants36 participants with hand skin tightening of SSc, two participants lost to follow up.InterventionsParticipants were randomised into wax bath versus no wax bath groups. Both groups in addition performed regular hand exercises as part of standard care. The study period was 9 weeks, with further measures of outcome undertaken at 18 weeks.Main outcome measuresThe primary outcome measure was the Hand Mobility in Scleroderma test (HAMIS). Secondary outcomes measures were the Scleroderma Health Assessment Questionnaire, grip and pinch strength and the Cochin Hand Function Scale.ResultsBetween group comparisons of HAMIS scores showed no evidence of effectiveness of the wax bath treatment at 9-week follow up (adjusted difference in means (95% CI) experimental-control −1.47 (−3.55 to 0.61), P = 0.16) or at 18-week follow up (adjusted difference in means (95% CI) experimental-control 1.94 (−1.07 to 4.95), P = 0.20). Analysis of secondary outcomes also showed no evidence for effectiveness of the wax bath treatment at either 9 or 18 weeks.ConclusionOur findings suggest that the addition of regular wax bath treatment confers no additional beneficial effect to standard care with daily home exercises.

KW - Exercise

KW - Physical therapy

KW - Rehabilitation

KW - Systemic sclerosis

KW - Wax baths

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UR - http://www.mendeley.com/research/randomised-controlled-trial-wax-baths-additive-therapy-hand-exercises-patients-systemic-sclerosis

U2 - 10.1016/j.physio.2018.08.008

DO - 10.1016/j.physio.2018.08.008

M3 - Article

SN - 0031-9406

VL - 105

SP - 370

EP - 377

JO - Physiotherapy

JF - Physiotherapy

IS - 3

ER -

A randomised controlled trial of wax baths as an additive therapy to hand exercises in patients with systemic sclerosis

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