Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 13, 2022
Open Peer Review Period: Feb 12, 2022 - Mar 2, 2022
Date Accepted: Mar 7, 2022
(closed for review but you can still tweet)
Effectiveness of hydrotherapy on neuropathic pain and pain catastrophization in patients with spinal cord injury: pilot trial study protocol
ABSTRACT
Background:
Neuropathic pain (NP) is one of the most frequent spinal cord injury (SCI) complications. Pain, quality of life, and functionality are associated and can lead to pain catastrophization. Pharmacological management of patients with NP secondary to SCI is widely known and there are increasing evidence in the area. Nevertheless, the non-pharmacological management is not fully elucidated since the efficacy is inconclusive.
Objective:
We hypothesis that (i) hydrotherapy is effective in reducing NP secondary to SCI. Additionally, secondary hypotheses are that (ii) hydrotherapy decreases the catastrophization of NP, and that (iii) hydrotherapy improves life quality and minimizes the degree of disability, when compared to physical therapy.
Methods:
A sample of 30 participants will be randomly assigned to either the intervention group (hydrotherapy), or control group (standard physical therapy). Both interventions will be provided twice a week, during a period of 9 weeks (18 sessions in total). Primary outcomes are changes in neuropathic pain perception and pain catastrophization. Secondary outcomes are changes in disability and quality of life scores. They will be assessed at baseline and follow-up at 4-weeks after discharge. Validated Spanish language scales will be used are: Numerical Pain Rating Scale, Pain Catastrophization, Health-related Quality of life and WHODAS 2.0. Generalized mixed linear models adjusted by confounders and interactions will be used for comparing baseline and post-intervention means of each group and their differences, together with 95% confidence intervals and p-values. Cohen's D will be calculated to identify the effect size of the differences. A p-value of less than 0.05 will be considered as statistically significant.
Results:
Recruitment began in April 2019 and we recruited the last participants by December 2019, 10 individuals were assigned to hydrotherapy and 8 to physical therapy (control). Results from the study will be disseminated via scientific publication, in clinicaltrials.gov results section, and in national and international conferences in second part of 2022.
Conclusions:
Trial will explore the effects of hydrotherapy on neuropathic pain, together with functionality and quality of life, in patients with spinal cord injury. This will further contribute towards strengthening the research for alternative therapeutic treatments which improve prognosis of pain and its’ subjective experience. Furthermore, this study explores evaluation of these therapeutic modalities, including perception variables and mental processes which may affect the clinical condition and rehabilitation outcomes in these patients. Clinical Trial: ClinicalTrials.gov, Identifier NCT04164810, Date of registration: November 15, 2019, https://clinicaltrials.gov/ct2/show/NCT04164810
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