Campo Andrés Reyes, Pacichana-Quinayáz Sara Gabriela, Bonilla-Escobar Francisco Javier, Leiva-Pemberthy Luz Miriam, Tovar-Sánchez Maria Ana, Hernández-Orobio Olga Marina, Arango-Hoyos Gloria-Patricia, Mujanovic Adnan
Departamento de Medicina Física y Rehabilitación, Grupo de Investigación en Rehabilitación de la Universidad del Valle, Universidad del Valle, Hospital Universitario del Valle, Cali, Colombia.
Fundación Somos Ciencia al Servicio de la Comunidad, Fundación SCISCO/Science to Serve the Community Foundation, SCISCO Foundation, Cali, Colombia.
JMIR Res Protoc. 2022 Apr 29;11(4):e37255. doi: 10.2196/37255.
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.
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.
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.
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.
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.
ClinicalTrials.gov NCT04164810; https://clinicaltrials.gov/ct2/show/NCT04164810.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37255.
神经性疼痛（NP）是脊髓损伤（SCI）最常见的并发症之一。疼痛、生活质量和功能相互关联，并可能导致疼痛灾难化。继发于SCI的NP患者的药物治疗广为人知，且该领域的证据越来越多。然而，非药物治疗尚未完全阐明，因为其疗效尚无定论。
我们假设（1）水疗对减轻继发于SCI的NP有效。此外，我们的次要假设是（2）与物理治疗相比，水疗可减少NP的灾难化，并且（3）水疗可改善生活质量并将残疾程度降至最低。
约20名参与者的样本将被随机分配至干预组（水疗）或对照组（标准物理治疗）。两种干预措施均为每周两次，为期9周（共18次疗程）。主要结局是神经性疼痛感知和疼痛灾难化的变化。次要结局是残疾和生活质量评分的变化。将在基线时以及出院后4周进行随访评估。将使用经过验证的西班牙语量表如下：数字疼痛评分量表、疼痛灾难化量表、健康相关生活质量量表以及世界卫生组织残疾评估量表2.0。将使用广义混合线性模型来比较每组的基线和干预后均值及其差异，以及95%置信区间和P值。P值小于0.05将被视为具有统计学意义。
招募工作于2019年4月开始，到2019年12月我们招募了最后一批参与者，其中10人被分配接受水疗，8人接受物理治疗（对照）。本研究结果将于2022年下半年通过科学出版物、ClinicalTrials.gov以及国内和国际会议进行传播。
本试验将探讨水疗对SCI患者神经性疼痛、功能和生活质量的影响。此外，本研究旨在评估这些治疗方式，包括感知变量和心理过程，这些可能会影响这些患者的临床状况和康复结局。水疗可能是继发于SCI的NP当前标准治疗的一种安全、有效且具有成本效益的替代方案，两者结果相当。
ClinicalTrials.gov NCT04164810；https://clinicaltrials.gov/ct2/show/NCT04164810。
国际注册报告识别码（IRRID）：DERR1-10.2196/37255。
