Effectiveness of a Psychoeducative Intervention on Patients With Cronic Low Back Pain (TNE)
Primary Purpose
Back Pain Lower Back Chronic
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic Neuroscience Education (TNE)
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain Lower Back Chronic focused on measuring Central Nervous System Sensitization, kinesiophobia
Eligibility 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)
Sites / Locations
- Hospital Universitario de San Juande AlicanteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervetion group
Control group
Arm Description
A sessions of "Therapeutic Neuroscience Education (TNE)" joint a physical exercises programs
Only a therapeutic physical exercises programs
Outcomes
Primary Outcome Measures
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")
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT03964389
First Posted
May 13, 2019
Last Updated
November 4, 2020
Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Hospital Universitario San Juan de Alicante
1. Study Identification
Unique Protocol Identification Number
NCT03964389
Brief Title
Effectiveness of a Psychoeducative Intervention on Patients With Cronic Low Back Pain
Acronym
TNE
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 22, 2021 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Hospital Universitario San Juan de Alicante
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain Lower Back Chronic
Keywords
Central Nervous System Sensitization, kinesiophobia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two-armed randomized trial
Masking
ParticipantOutcomes Assessor
Masking Description
Participants receive TEN sessions, but do not know that one of the groups will receive extra information
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervetion group
Arm Type
Experimental
Arm Description
A sessions of "Therapeutic Neuroscience Education (TNE)" joint a physical exercises programs
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Only a therapeutic physical exercises programs
Intervention Type
Other
Intervention Name(s)
Therapeutic Neuroscience Education (TNE)
Other Intervention Name(s)
Pain Neuroscience Education" (PNE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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")
Time Frame
6 weeks following the reported onset of symptoms.
Secondary Outcome Measure Information:
Title
Pain Catastrophizing: Pain Catastrophizing Scale
Description
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
Time Frame
baseline; 1 day after intervention; and 6 weeks
Title
Kinesiophobia: Tampa Scale for Kinesiophobia
Description
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.
Time Frame
baseline; 1 day after intervention; and 6 weeks
Other Pre-specified Outcome Measures:
Title
Quality of live: Questionnaire Euroquol-5D (EQ-5D)
Description
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"
Time Frame
baseline; 1 day after intervention; and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria I Tomás-Rodríguez, Phd
Phone
+34607326334
Email
mitomas@umh.es
Facility Information:
Facility Name
Hospital Universitario de San Juande Alicante
City
San Juan De Alicante
State/Province
Alicante
ZIP/Postal Code
03550
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M Isabel Tomás.Rodríguez, PhD
Phone
+34965919513
Email
mitomas@umh.es
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27351541
Citation
Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
Results Reference
background
PubMed Identifier
22133255
Citation
Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
Results Reference
background
PubMed Identifier
30398542
Citation
Traeger AC, Lee H, Hubscher M, Skinner IW, Moseley GL, Nicholas MK, Henschke N, Refshauge KM, Blyth FM, Main CJ, Hush JM, Lo S, McAuley JH. Effect of Intensive Patient Education vs Placebo Patient Education on Outcomes in Patients With Acute Low Back Pain: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):161-169. doi: 10.1001/jamaneurol.2018.3376.
Results Reference
background
Links:
URL
https://www.retrainpain.org/
Description
Learn a science based approach to overcome chronic pain.
URL
http://www.paininmotion.be/
Description
An international research group that focuses on pain an dody movement
Learn more about this trial
Effectiveness of a Psychoeducative Intervention on Patients With Cronic Low Back Pain
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