Effectiveness of Hydrotherapy on Neuropathic Pain and Pain Catastrophization in Patients With Spinal Cord Injury: Protocol for a Pilot Trial Study.

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 is increasing evidence in the area. Nevertheless, nonpharmacological management is not fully elucidated since its efficacy is inconclusive.

OBJECTIVE

We hypothesize that (1) hydrotherapy is effective in reducing NP secondary to SCI. Additionally, our secondary hypotheses are that (2) hydrotherapy decreases the catastrophization of NP, and that (3) hydrotherapy improves life quality and minimizes the degree of disability, when compared to physical therapy.

METHODS

A sample of approximately 20 participants will be randomly assigned to either the intervention (hydrotherapy) or control group (standard physical therapy). Both interventions will be administered twice a week over a 9-week period (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 that will be used are the following: Numerical Pain Rating Scale, Pain Catastrophization, Health-related Quality of life, and the World Health Organization's Disability Assessment Schedule 2.0. Generalized mixed linear models will be used for comparing baseline and postintervention means of each group and their differences, together with 95% CIs and P values. A P value of less than .05 will be considered significant.

RESULTS

Recruitment began in April 2019, and we recruited the last participants by December 2019, with 10 individuals assigned to hydrotherapy and 8 to physical therapy (control). Results from this study will be disseminated via scientific publication, in ClinicalTrials.gov, and in national and international conferences in the latter half of 2022.

CONCLUSIONS

This trial will explore the effects of hydrotherapy on neuropathic pain, together with functionality and quality of life, in patients with SCI. Furthermore, this study aims to evaluate these therapeutic modalities, including perception variables, and mental processes, which may affect the clinical condition and rehabilitation outcomes in these patients. Hydrotherapy is likely to be a safe, efficient, and cost-effective alternative to the current standard of care for NP secondary to SCI, with comparable results between the two.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04164810; https://clinicaltrials.gov/ct2/show/NCT04164810.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37255.