Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Neuropathic Pain
  • Spinal Cord Injuries
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Pain, quality of life and functionality are associated with each other, and patients with SCI are affected by each (4, 5) thus producing limitations in the participation of daily activities and self-care. Pain, mainly chronic pain, has an effect on emotional states as well as cognition regarding pai...

Pain, quality of life and functionality are associated with each other, and patients with SCI are affected by each (4, 5) thus producing limitations in the participation of daily activities and self-care. Pain, mainly chronic pain, has an effect on emotional states as well as cognition regarding pain and anticipation which lead to catastrophization. The previously mentioned is broadly related to chronic diseases that present pain of poor prognosis and are detrimental to quality of life and risk of suicide (6-9) thus having enormous impacts on health systems. The effects of hydrotherapy in patients with NP secondary to SCI are unknown which is why this study aims to evaluate the effectiveness of hydrotherapy in the decrease of NP, catastrophization of pain, quality of life and disability in a group of patients with SCI. The main hypothesis of the study is that (i) hydrotherapy is effective in reducing neuropathic pain in patients with NP secondary to SCI. Likewise, another hypothesis to prove is that (ii) hydrotherapy decreases the catastrophization of neuropathic pain in patients with NP secondary to SCI compared to standard physical therapy, and that (iii) hydrotherapy improves the quality of life and the disability of patients with NP secondary to SCI compared to standard physical therapy. This study is a randomized controlled clinical trial of parallel groups under conditions of usual clinical practice. Participants will be selected from the list of patients attending the Spinal Trauma Clinic of the Physical Medicine and Rehabilitation Unit of a Specialized Trauma Center. Those eligible for the study are patients whose clinical evaluation and physical examination result in a diagnosis of neuropathic pain secondary to trauma according to the International Spinal Cord Injury Pain (ISCIP), and those that meet the following criteria: over 18 years of age and a DN-score 4 (Douleur Neuropathique-4) equal to or greater than 4 and level of injury below C3. Those eligible for the study are patients whose clinical evaluation and physical examination result in a diagnosis of neuropathic pain secondary to trauma according to the International Spinal Cord Injury Pain (ISCIP), and those that meet the following criteria: over 18 years of age and a DN-score 4 (Douleur Neuropathique-4) equal to or greater than 4 and level of injury below C3. Te population requires a medical evaluation, when it is finished, the participants will be randomized into the control and intervention groups. The patient will be informed and reminded via phone call about the first day of therapy initiation. The comparison groups will be: Intervention Group (Hydrotherapy) and Control Group (Standard Physical Therapy). Participants will be assessed at the following times (Figure 2. Timeline): Measurement 1 - Baseline - At the beginning of the intervention (Both groups start in their respective groups, for 9 weeks). Measurement 2 - At the end of the intervention (one month after the end of the interventions). The participants assigned to the intervention (hydrotherapy) will receive the treatment for 9 weeks (2 days per week) , resulting in a total of 18 sessions of Hydrotherapy. Each session will be held for a duration of 45 minutes to 1 hour. Likewise, the control group will have 18 standard physical therapy treatment sessions during the same 9 weeks, with the same duration for each session as the hydrotherapy group. The instruments that will be used are validated worldwide. The DN-4 (Douleur Neuropathique-4 items, to identify the presence of neuropathic pain, scale of catastrophization of pain and intensity of neuropathic pain. Pain Catastrophization Scale (PCS - Pain Catastrophizing Scale) and the Numerical Pain Scale (END) will be used to catastrophization of pain and intensity of neuropathic pain.

Tracking Information

NCT #
NCT04164810
Collaborators
Not Provided
Investigators
Not Provided