免费获得国外相关药品，最快 1 个工作日回馈药物信息
Effectiveness of a Psychoeducative Intervention on Patients With Cronic Low Back Pain (TNE)
One of the treatment modalities currently available in this hospital to treat this type of patients with low back pain who present with chronic pain are the group sessions that are carried out to provide information to the patient about the anatomy, biomechanics and ergonomics and are complemented with sessions of physical exercise. Based on the latest publications on treatment of this type of patients, The investigators have seen that this intervention is insufficient, and that it could be improved by combining education based on Therapeutic Neuroscience Education (TNE)).
The present study proposes implementing this program to a randomly assigned group of patients participating in the group sessions aimed at patients with lumbar pain called "Back-pain Protocol" that are currently relized in the Physiotherapy Area of a hospital; and compare the results of this intervention with those obtained in another group that will only carry out the sessions with the traditional method that is currently used.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Back Pain Lower Back Chronic | Other: Therapeutic Neuroscience Education (TNE) | Not Applicable |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | two-armed randomized trial |
| Masking: | Double (Participant, Outcomes Assessor) |
| Masking Description: | Participants receive TEN sessions, but do not know that one of the groups will receive extra information |
| Primary Purpose: | Treatment |
| Official Title: | Effectiveness of Therapeutic Neuroscience Education (TNE) on Patients Who Are Participating in Therapeutic Exercises Programs to Treat Cronic Low Back Pain: a Two-armed Randomized Trial |
| Estimated Study Start Date : | January 22, 2021 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | October 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Intervetion group
A sessions of "Therapeutic Neuroscience Education (TNE)" joint a physical exercises programs
|
Other: Therapeutic Neuroscience Education (TNE)
A talk on Neuroscience Education (EN). This intervention aims to provide information in a clear and simple way to the participants so that through it the patients may be able to modify their attitude towards pain, inviting them to take a more active and less contemplative role. Neuroscience has shown that it is possible to have persistent pain without damage to the tissues or with damage that justifies the perceived disproportion of pain.
Other Name: Pain Neuroscience Education" (PNE)
|
|
No Intervention: Control group
Only a therapeutic physical exercises programs
|
- Numeric Pain Rating Scale (NPRS) [ Time Frame: 6 weeks following the reported onset of symptoms. ]The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
- Pain Catastrophizing: Pain Catastrophizing Scale [ Time Frame: baseline; 1 day after intervention; and 6 weeks ]Pain Catastrophizing Scale. Catastrophic thinking has widely been recognized in the development and maintenance of hypochondriasis and anxiety disorders.The PCS is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). The PCS is broken into three subscales being magnification, rumination, and helplessness. The scale was developed as a self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations. ranges from '0' representing no pain catastrophizing to '52' representing maximum pain catastrophizing
- Kinesiophobia: Tampa Scale for Kinesiophobia [ Time Frame: baseline; 1 day after intervention; and 6 weeks ]The Tampa Scale for Kinesiophobia (TSK) is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. ... The TSK is a self-completed questionnaire and the range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia.
- Quality of live: Questionnaire Euroquol-5D (EQ-5D) [ Time Frame: baseline; 1 day after intervention; and 6 weeks ]
The EQ-5D questionnaire has two components: health state description and evaluation.
In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression The evaluation part is a Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine"
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients participating in the "back protocol" groups in the hospital
- That present pain of more than 3 months of evolution
Exclusion Criteria:
- Oncological pain
- Fracture or spinal surgery in the last year
- Cognitive neurological alteration that prevents understanding the contents of the session
- Alterations at the motor level that prevent the realization of the program of directed physical exercise that is currently carried out
- Pregnancy
- Urinary or intestinal incontinence
- Other clinical conditions that may aggravate chronic spinal pain (chronic fatigue syndrome, fibromyalgia and complex regional pain syndrome)
| Contact: Maria I Tomás-Rodríguez, Phd | +34607326334 | mitomas@umh.es |
| Spain | |
| Hospital Universitario de San Juande Alicante | Recruiting |
| San Juan De Alicante, Alicante, Spain, 03550 | |
| Contact: M Isabel Tomás.Rodríguez, PhD +34965919513 mitomas@umh.es | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 13, 2019 | ||||
| First Posted Date ICMJE | May 28, 2019 | ||||
| Last Update Posted Date | November 6, 2020 | ||||
| Estimated Study Start Date ICMJE | January 22, 2021 | ||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Numeric Pain Rating Scale (NPRS) [ Time Frame: 6 weeks following the reported onset of symptoms. ] The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
Quality of live: Questionnaire Euroquol-5D (EQ-5D) [ Time Frame: baseline; 1 day after intervention; and 6 weeks ] The EQ-5D questionnaire has two components: health state description and evaluation.
In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression The evaluation part is a Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine"
|
||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of a Psychoeducative Intervention on Patients With Cronic Low Back Pain | ||||
| Official Title ICMJE | Effectiveness of Therapeutic Neuroscience Education (TNE) on Patients Who Are Participating in Therapeutic Exercises Programs to Treat Cronic Low Back Pain: a Two-armed Randomized Trial | ||||
| Brief Summary |
One of the treatment modalities currently available in this hospital to treat this type of patients with low back pain who present with chronic pain are the group sessions that are carried out to provide information to the patient about the anatomy, biomechanics and ergonomics and are complemented with sessions of physical exercise. Based on the latest publications on treatment of this type of patients, The investigators have seen that this intervention is insufficient, and that it could be improved by combining education based on Therapeutic Neuroscience Education (TNE)). The present study proposes implementing this program to a randomly assigned group of patients participating in the group sessions aimed at patients with lumbar pain called "Back-pain Protocol" that are currently relized in the Physiotherapy Area of a hospital; and compare the results of this intervention with those obtained in another group that will only carry out the sessions with the traditional method that is currently used. |
||||
| Detailed Description |
Process The physiotherapist responsible for programs group to treat chronic back pain ( "Back-pain Protocol") will be contacted. The study will be explained and material and training will be provided to carry out the TNE session. Subsequently, participants who meet the inclusion criteria will be detected and assigned to the intervention group or to the control group after a randomisation process. At the end of the first session that is currently taking place in the programs to treat chronic back pain in groups, the physiotherapist will explain the study and will ask them to collaborate. The information sheet will be provided. Those who decide to participate will receive an informed consent and some questionnaires to complete: the Numeric Pain Rating Scale (NPRS) to assess their degree of pain, the Central Sensitization Inventory, the Pain Catastrophic Scale (Spanish version), the Tampa Kinesiofobia Scale (TSK) "and EuroQol-5D Cuetionario. Interventions The protocol that is currently carried out consists of five sessions spread over a month and a half. Patients come in two groups of 10 people each day, with a duration of one hour, in the Rehabilitation classroom. The first session, which consists of an informative talk. The physiotherapist provides information and explanations about the "back pain protocol". The physiotherapist explains the problems of attitude and gestures that can benefit or harm their treatment, their activities of daily life, their work and the performance of sports activities. In the second, third and fourth sessions, participants learn to do specific exercises for back pain. Patients receive a booklet with the exercises and postures to adopt in the habits of daily life. In the fifth and final session, a final review of everything learned is done and the final evaluation is requested (the Numeric Pain Rating Scale (NPRS) to assess their degree of pain, the Central Sensitization Inventory, the Catastrophism Scale of the Pain (Spanish version), the Tampa Kinesiofobia Scale (TSK) "and EuroQol-5D Cuetionario). Treatment. This study proposes that only participants assigned to the intervention group will also receive an additional session of patient education about Therapeutic Neuroscience Education (TNE) The duration of this session will be one hour and will be carried out the day after the first informative session of the current protocol, in an additional session. In addition, they will be provided with information to read and review at home. Only patients who have been randomly assigned to the intervention group will attend this session. This intervention aims to provide information in a clear and simple way to the participants so that through it the patients can modify their attitude towards pain, inviting them to assume a more active and less contemplative role. The physiotherapist will explain in a simple way to the participants that chronic pain is not always the result of tissue damage. Neuroscience has shown that it is possible to have persistent pain without damaging the tissues or with damage that justifies the perception of the disproportion of pain. In addition, the physiotherapist will explain the difference between acute pain and chronic pain, central sensitization processes (CS) and endogenous pain control mechanisms. The physiotherapist will talk about how thoughts, beliefs and emotions modify the painful experience and how the erroneous information received, and sometimes iatrogenic, modifies the mechanisms of pain processing. The contents of talks on education in neuroscience are based on the book Explain Pain. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: two-armed randomized trial Masking: Double (Participant, Outcomes Assessor)Masking Description: Participants receive TEN sessions, but do not know that one of the groups will receive extra information Primary Purpose: Treatment
|
||||
| Condition ICMJE | Back Pain Lower Back Chronic | ||||
| Intervention ICMJE | Other: Therapeutic Neuroscience Education (TNE)
A talk on Neuroscience Education (EN). This intervention aims to provide information in a clear and simple way to the participants so that through it the patients may be able to modify their attitude towards pain, inviting them to take a more active and less contemplative role. Neuroscience has shown that it is possible to have persistent pain without damage to the tissues or with damage that justifies the perceived disproportion of pain.
Other Name: Pain Neuroscience Education" (PNE)
|
||||
| Study Arms ICMJE |
|
||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
120 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | October 2021 | ||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
||||
| Listed Location Countries ICMJE | Spain | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03964389 | ||||
| Other Study ID Numbers ICMJE | 19/ 317 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE |
|
||||
| Responsible Party | María Isabel Tomás Rodríguez, Universidad Miguel Hernandez de Elche | ||||
| Study Sponsor ICMJE | Universidad Miguel Hernandez de Elche | ||||
| Collaborators ICMJE | Hospital Universitario San Juan de Alicante | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Universidad Miguel Hernandez de Elche | ||||
| Verification Date | November 2020 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||
