Neuropathic PainNCT04164810
Effects of Hydrotherapy on Neuropathic Pain and Pain Catastrophization in Spinal Cord Injury
A study testing Hydrotherapy and Physical Therapy in people with Neuropathic Pain and Spinal Cord Injuries, run by Universidad del Valle, Colombia at 1 site in Colombia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Spinal Cord Injuries
- What is being tested?
- Hydrotherapy and Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteColombia
- Study dates
- 1 Sep 2018to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Hospital Universitario del Valle "Evaristo García" ESE
Cali, Valle del Cauca Department
Maria Ana Tovar-Sánchez, Physiatrist, +57 3104096531, ana.tovar@correounivalle.edu.co
About this study
Official title: Effects of Hydrotherapy on Neuropathic Pain and Pain Catastrophization in Spinal Cord Injury: Study Protocol for a Randomized Controlled Trial
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.
Read the detailed 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 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.
- Conditions
- Neuropathic Pain, Spinal Cord Injuries
- Being tested
- Hydrotherapy, Physical Therapy
- Keywords
- Spinal cord injury, Neuropathic pain, Quality of life, Catastrophization
- Medical subject headings
- Neuralgia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrotherapyOther
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.
Physical TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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 .
Measured: 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 is made up of 36 items distributed in sub-scales of physical functioning, physical role, body pain, general health, vitality, social function, emotional role and mental health, all with Likert questions and dichotomous (Yes / No) questions with the minimum score being 0 and the maximum 100
Measured: 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 is used worldwide and inquires about the difficulties that the individual has due to a particular health condition. For this study, the 12-item version will be used, which is made up of a Likert scale ranging from 'no difficulty" (1) to 'extreme difficulty' / 'cannot do it' (5). The scores will be averaged for analysis
Measured: it going to be apply in the session number 1 and 18, and the application time is 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Sep 2018
- Primary completionMay 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad del Valle, Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164810
- Sponsor's protocol ID
- CI-1845
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35486436
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hydrotherapy on Neuropathic Pain and Pain Catastrophization in Spinal Cord Injury: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04164810
- Acronym / sponsor ID
- CI-1845
- Conditions
- Neuropathic Pain, Spinal Cord Injuries
- Keywords
- Spinal cord injury, Neuropathic pain, Quality of life, Catastrophization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad del Valle, ColombiaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrotherapy | Experimental | Other: HydrotherapyHydrotherapy 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. |
| Physical therapy | Active comparator | Other: Physical TherapyPhysical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Active pressure ulcers
- An E classification in the ASIA (American Spinal Cord Injury Association)
- Cognitive impairment
- Ostomies
- Permanent bladder catheter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrotherapyAll 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. | Other | Hydrotherapy |
| Physical TherapyAll sessions will be done by 3 physical therapists expert in neurorehabilitation, following a physical therapy protocol, which includes stretching, aerobic excercise and muscle strengthening. | Other | Physical therapy |
Primary outcome
DN-4 (Douleur Neuropathique-4 items)
Time frame: it going to be apply in the session number 1 and 18, and the application time is 10 minutes
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
Pain Catastrophization Scale (PCS - Pain Catastrophizing Scale)
Time frame: it going to be apply in the session number 1 and 18, and the application time is 20 minutes
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)
Numerical Pain Scale (END)
Time frame: it going to be apply in the session number 1 and 18, and the application time is 1 minute
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 .
2 secondary outcomes
Spanish version of the Quality Short-Form Health Survey 36 (SF-36)
Time frame: 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)
Time frame: it going to be apply in the session number 1 and 18, and the application time is 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Derived from this study: PubMed 35486436Campo 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.
Related trials for Neuropathic Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrotherapy and Physical Therapy in people with Neuropathic Pain and Spinal Cord Injuries, run by Universidad del Valle, Colombia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara G Pacichana, MSc (+57 3122128016, sara.pacichana@correounivalle.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DN-4 (Douleur Neuropathique-4 items) (time frame: it going to be apply in the session number 1 and 18, and the application time is 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04164810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.