Effects of Hydrotherapy on Neuropathic Pain and Pain Catastrophization in Spinal Cord Injury

NCT04164810 | Unknown

• 1 other identifier: CI-1845
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal Cord Injury (SCI) is a spinal cord injury of traumatic origin with its main etiology being violence, which constitutes one of the greatest social and health problems worldwide. One of the complications with the greatest impact in people with SCI is Neuropathic Pain (NP). Pain, mainly chronic pain, has an effect on emotional states, cognition regarding pain and anticipation which leads to the catastrophization of the pain. This form of pain is related to chronic diseases that develop with pain of poor prognosis and are detrimental to quality of life therefore having enormous impacts on health systems. The physiological mechanisms of Hydrotherapy on pain are clear and there is evidence of its use in the management of painful syndromes of difficult treatments such as that for fibromyalgia and chronic lumbar pain, as well as its positive effect on pain perception. However, the effects of hydrotherapy on the NP of patients with SCI are unknown. Randomized, controlled clinical trial of parallel groups. A randomized sequence will be carried out in balanced blocks to assign the intervention (Hydrotherapy) or the control (Standard Physical Therapy), to a sample of 28 participants, 14 for each group. Each of the interventions (hydrotherapy and physical therapy) will last 9 weeks, for a total of 18 sessions (2 weekly sessions). Two measurements will be made, baseline (pre-intervention) and a second time one month after the end of the intervention. The validated Spanish scales will be used: NP-4 (NP Screening), Numerical Pain Scale (END), PCS (Pain Catastrophization), SF-36 (Health-related quality of life) and WHODAS 2.0 (Disability). The primary outcome is the level of NP and its catastrophization, and the secondary outcomes are level of disability and quality of life. With 28 participants fully measured, it is possible to have 80% power to find differences between the groups with respect to the primary outcomes. All information will be analyzed using average comparisons with 95% confidence. The analysis will be carried out by Intention to Treat (ITT) taking all the randomized participants. Missing data will be processed through multiple imputation chains. Generalized mixed linear models will be used comparing the standardized baseline and post-intervention averages of each group and between each group, obtaining 95% confidence intervals and p-values. Subgroup analysis will be performed adjusting confounders and interactions. A significant difference will be considered when the value of p is less than 0.05. Cohen´s D will be calculated to identify the size of the intervention effect. Discussion: The results will reflect the effect of the hydrotherapy on NP in patients with SCI. They will also permit the identification of potential changes in functionality levels or quality of life in the intervened population.

Conditions

Neuropathic Pain; Spinal Cord Injuries

Keywords

Spinal cord injury; Neuropathic pain; Quality of life; Catastrophization

Outcome Measures

Primary Outcomes (3)

• DN-4 (Douleur Neuropathique-4 items)

  consists of 10 items: 7 related to the quality of pain through an interview and the other 3 items through a clinical exam. This questionnaire, which is validated in Spanish (27), consists of descriptions and signs of pain that are evaluated dichotomously (Yes / No) to identify patients who have a high probability of having a neuropathic pain component. The scores of the individual items are added together to obtain a maximum total score of 10, with a cut-off point ≥ 4

  it going to be apply in the session number 1 and 18, and the application time is 10 minutes

• Pain Catastrophization Scale (PCS - Pain Catastrophizing Scale)

  The PCS is an instrument validated in Spanish for pathologies such as fibromyalgia and amputee patients, which inquires about the thoughts and feelings that arise in the presence of physical pain caused by diseases, wounds, surgeries, etc. This scale has 13 items rated on a Likert scale from 0 to 4 (0 = Nothing at all; 1 = A little; 2 = Moderately; 3 = A lot; 4 = All time)

  it going to be apply in the session number 1 and 18, and the application time is 20 minutes

• Numerical Pain Scale (END)

  used in various clinical settings for multiple health conditions, and measures pain intensity subjectively through a rating of 0 to 10, where 0 means no pain and 10 the worst pain experienced .

  it going to be apply in the session number 1 and 18, and the application time is 1 minute

Secondary Outcomes (2)

• Spanish version of the Quality Short-Form Health Survey 36 (SF-36)

  it going to be apply in the session number 1 and 18, and the application time is 20 minutes

• WHODAS 2.0 questionnaire of the World Health Organization (WHO)

  it going to be apply in the session number 1 and 18, and the application time is 10 minutes

Study Arms (2)

Hydrotherapy

EXPERIMENTAL

Hydrotherapy intervention 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.

Other: Hydrotherapy

Physical therapy

ACTIVE COMPARATOR

Physical therapy inthervention will have 18 standard physical therapy treatment sessions during 9 weeks. Each session will be held for a duration of 45 minutes to 1 hour.

Other: Physical Therapy

Interventions

Hydrotherapy OTHER

All sessions will be done by 3 physical therapists specialized in hydrotherapy under different modalities, and a pool equipped to perform this type of intervention. The most commonly used techniques in the institution are Bad Ragaz, for motor control, and the Watsu technique for relaxation and spasticity work.

Hydrotherapy

Physical Therapy OTHER

All sessions will be done by 3 physical therapists expert in neurorehabilitation, following a physical therapy protocol, which includes stretching, aerobic excercise and muscle strengthening.

Physical therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with spinal cord injury.
• Over 18 years of age.
• A DN-score 4 (Douleur Neuropathique-4) equal to or greater than 4.
• level of injury below C3.

You may not qualify if:

• Active pressure ulcers
• An E classification in the ASIA (American Spinal Cord Injury Association)
• Cognitive impairment
• Ostomies
• Permanent bladder catheter
• Signs of systemic inflammatory response
• Urinary symptoms

Sponsors & Collaborators

• Universidad del Valle, Colombia: lead

Study Sites (1)

Hospital Universitario del Valle "Evaristo García" ESE

Cali, Valle del Cauca Department, Colombia

RECRUITING

Related Publications (1)

• Campo AR, Pacichana-Quinayaz SG, Bonilla-Escobar FJ, Leiva-Pemberthy LM, Tovar-Sanchez MA, Hernandez-Orobio OM, Arango-Hoyos GP, Mujanovic A. Effectiveness of Hydrotherapy on Neuropathic Pain and Pain Catastrophization in Patients With Spinal Cord Injury: Protocol for a Pilot Trial Study. JMIR Res Protoc. 2022 Apr 29;11(4):e37255. doi: 10.2196/37255.

  PMID: 35486436 DERIVED

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries

Interventions

Hydrotherapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Sara G Pacichana, MSc

CONTACT

+57 3122128016; sara.pacichana@correounivalle.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 15, 2019
• Study Start: September 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 15, 2019

Record last verified: 2019-11

Locations

CO (1)