Effectiveness of a Psychoeducative Intervention on Patients With Cronic Low Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Back Pain Lower Back Chronic

Intervention / Treatment
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* Other: Therapeutic Neuroscience Education (TNE)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two-armed randomized trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervetion group<br>A sessions of Therapeutic Neuroscience Education (TNE) joint a physical exercises programs | Other: Therapeutic Neuroscience Education (TNE)<br>* 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.<br>* Other names: Pain Neuroscience Education (PNE);|
| No Intervention: Control group<br>Only a therapeutic physical exercises programs | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale (NPRS) | 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) | 6 weeks following the reported onset of symptoms. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Catastrophizing: Pain Catastrophizing Scale | 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 | baseline; 1 day after intervention; and 6 weeks | 
| Kinesiophobia: Tampa Scale for Kinesiophobia | 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. | baseline; 1 day after intervention; and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central Nervous System Sensitization, kinesiophobia