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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964389
Recruitment Status : Not yet recruiting
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Sponsor:
Collaborator:
Hospital Universitario San Juan de Alicante
Information provided by (Responsible Party):
María Isabel Tomás Rodríguez, Universidad Miguel Hernandez de Elche

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.


Condition or disease Intervention/treatment Phase
Back Pain Lower Back Chronic Other: Therapeutic Neuroscience Education (TNE) Not Applicable

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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 : June 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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



Primary Outcome Measures :
  1. 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")


Secondary Outcome Measures :
  1. 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

  2. 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.


Other Outcome Measures:
  1. 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"




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964389


Contacts
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Contact: Maria I Tomás-Rodríguez, Phd +34607326334 mitomas@umh.es

Sponsors and Collaborators
Universidad Miguel Hernandez de Elche
Hospital Universitario San Juan de Alicante
Additional Information:
Publications:
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Responsible Party: María Isabel Tomás Rodríguez, Principal Investigator, Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier: NCT03964389    
Other Study ID Numbers: 19/ 317
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by María Isabel Tomás Rodríguez, Universidad Miguel Hernandez de Elche:
Central Nervous System Sensitization
kinesiophobia
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations