Back to resultsOnline Intervention Based on Pain Neuroscience Education for Women With Pregnancy-related Lumbopelvic Pain
Primary Purpose
Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pain neuroscience education
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria: pregnant women older than 18 years, who are in the early third trimester of pregnancy; minimum score of 3/10 on the numerical pain scale over the past week. Exclusion Criteria: multiple pregnancy; previous spinal surgery; presence of psychiatric disorders; women who have participated in similar programs or interventions before enrollment.
Sites / Locations
- JF LisónRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Pain neuroscience education (PNE)
Prenatal education (PE)
Arm Description
The patients in the intervention group will receive, in addition to the prenatal educational content, the 12 PNE lessons in audiovisual format. Each lesson will last between 10-15 minutes. The contents of PNE will be an adaptation, focused on the context of a pregnant woman, of the Butler & Moseley postulates. These contents have already been previously adapted according to the nature of the patients' pain, both in chronic pain and in acute pain. In summary, the participants will receive a detailed explanation about the biopsychosocial component of pain through the use of diagrams, metaphors and practical examples. In turn, the objectives of this program could be summarized as: (1) Reformulate erroneous beliefs about pain, (2) Inform about the biology and protective nature of pain and (3) Provide techniques to reduce kinesiophobia and, consequently, promote physical activity, with the beneficial effect it entails for patients with pain.
Patients assigned to the PE group will receive different content on standard PE based on the Pregnancy and Postpartum Clinical Practice Guide, consisting of general information about pregnancy (visits and monitoring of pregnancy, diet, phases of delivery, lactation, etc.), as well as specific recommendations for lumbopelvic pain associated with pregnancy. These contents will be developed by midwives from the participating hospitals. Participants will receive 12 educational sessions, with an estimated duration of 10 minutes each.
Outcomes
Primary Outcome Measures
Pain intensity
The primary outcome will be mean pain intensity over the previous week assessed using an 11-point numerical rating scale (range, 0 [no pain] to 10 [worst pain imaginable]).
Secondary Outcome Measures
Disability
The Roland Morris questionnaire will be used. This is a validated questionnaire for the Spanish population and has previously been used in women with lumbopelvic pain. The questionnaire assesses the degree of physical disability in patients with non-specific low back pain and is made up of 24 items that describe daily activities that may be difficult to perform due to low back pain. A point is added to each item marked "yes", and a maximum score of 24 points can be obtained. The greater the number of positive responses, the greater the disability.
Kinesiophobia
The short version of the Tampa TSK-11 kinesiophobia scale will be used The Spanish version of this scale has been validated in patients with acute and chronic low back pain. The scale consists of 11 items, in which each item receives a score from 1 to 4 on the Likert scale (1=strongly disagree; 4=strongly agree). The score ranges from 11 to 44 points, with higher scores indicating a greater fear of movement.
Pain catastrophizing
The pain catastrophizing scale is an instrument made up of 13 items (each item scores between 0 and 4), which measures the degree to which patients develop feelings and thoughts related to their nociceptive experience. This scale, which has a validated version for Spanish, shows adequate internal consistency.
Appreciation of body functionality
It will be measured using the Functionality Appreciation Scale (FAS). This questionnaire consists of 7 items scored on a Likert-type scale of 1 (very disagree) to 5 (strongly agree). Higher scores reflect a greater appreciation of functionality. Appreciation of body functionality is one of the dimensions of the concept of positive body image that focuses not on appearance, but on in the perception of the body's capabilities and its unconditional acceptance.There is preliminary evidence indicating that the appreciation of body functionality may be a relevant component in the context of low back pain, with patients with worse results on this scale showing worse evolution of their pain with respect to controls.To the best of our knowledge, this dimension has not been assessed in any study of low back pain in pregnant women.
Body Vigilance
It will be measured using the Body Vigilance subscale of the Objectified Body Consciousness Scale questionnaire. This subscale is based on the premise that women are the object of constant attention by virtue of the appearance of their bodies (objectification), and that this leads them to permanent self-monitoring of their bodies to ensure that they conform to the canons of dominant beauty. The negative effects that the experience of self-objectification can produce in women are known, affecting not only their psychological state, but also consequently their physical state. A 2011 study of pregnant women found that increased body surveillance was associated with depressive symptoms and consequently unhealthy prenatal behaviors. However, the implications that could exist between this relationship and the appearance and maintenance of non-specific low back pain in pregnant women have not been studied to date.
Anxiety and depression
The Hospital Anxiety and Depression Scale (HADS) questionnaire will be used. This consists of 14 questions, of which 7 assess symptoms of anxiety (HADS-A) and 7 measure symptoms of depression (HADS-D). Each item scores from 0 to 3, with a score range in each subscale from 0-21. Scores of 0-7 indicate no anxiety or depression; scores between 8-10 indicate medium levels; scores of 11-14 indicate moderate levels and scores of 15-21 indicate severe levels of anxiety or depression. The HADS scale has good internal consistency, reliability, and validity.
Level of physical activity
The abbreviated version of the international physical activity questionnaire (International Physical Activity Questionnaire - IPAQ - short) will be used. This is a self-administered questionnaire consisting of 7 items and collecting information on physical activity performed in the last 7 days. This questionnaire has been previously validated in 12 countries and shows adequate psychometric properties. The short version (IPAD-SF) has shown acceptable validity in the Spanish adult population.
Full Information
NCT ID
NCT05976854
First Posted
July 28, 2023
Last Updated
August 29, 2023
Sponsor
Cardenal Herrera University
1. Study Identification
Unique Protocol Identification Number
NCT05976854
Brief Title
Online Intervention Based on Pain Neuroscience Education for Women With Pregnancy-related Lumbopelvic Pain
Official Title
Effects of an Online Intervention Based on Pain Neuroscience Education for Women With Pregnancy-related Lumbopelvic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2023 (Actual)
Primary Completion Date
February 10, 2024 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
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
60-70% of pregnant women suffer from pregnancy-related lumbopelvic pain. In the general population, patient education is the first line of treatment. For pregnant women with LBP, the guidelines are the same as for the general population. In fact, prenatal education programs specifically collect recommendations and educational strategies for managing this pain. Within educational strategies, education in the neuroscience of pain has gained special relevance in recent years due to its positive results in reducing pain in patients with low back pain. Despite the beneficial effects shown in patients with low back pain, its use has not yet been explored, to our knowledge, in women with pregnancy-related lumbopelvic pain.
Detailed Description
60-70% of pregnant women suffer from pregnancy-related lumbopelvic pain. Its multifactorial origin makes it difficult to establish an appropriate treatment for pain control. In the general population, patient education is the first line of treatment. For pregnant women with LBP, the guidelines are the same as for the general population. In fact, prenatal education programs specifically collect recommendations and educational strategies for managing this pain. Within educational strategies, education in the neuroscience of pain has gained special relevance in recent years due to its positive results in reducing pain in patients with low back pain. This type of education is based on reconceptualizing pain through teaching the neurobiological mechanisms that underlie the pain experience. Despite the beneficial effects shown in patients with low back pain, its use has not yet been explored, to our knowledge, in pregnant women with pregnancy-related low back and pelvic pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pain neuroscience education (PNE)
Arm Type
Experimental
Arm Description
The patients in the intervention group will receive, in addition to the prenatal educational content, the 12 PNE lessons in audiovisual format. Each lesson will last between 10-15 minutes. The contents of PNE will be an adaptation, focused on the context of a pregnant woman, of the Butler & Moseley postulates. These contents have already been previously adapted according to the nature of the patients' pain, both in chronic pain and in acute pain. In summary, the participants will receive a detailed explanation about the biopsychosocial component of pain through the use of diagrams, metaphors and practical examples. In turn, the objectives of this program could be summarized as: (1) Reformulate erroneous beliefs about pain, (2) Inform about the biology and protective nature of pain and (3) Provide techniques to reduce kinesiophobia and, consequently, promote physical activity, with the beneficial effect it entails for patients with pain.
Arm Title
Prenatal education (PE)
Arm Type
Other
Arm Description
Patients assigned to the PE group will receive different content on standard PE based on the Pregnancy and Postpartum Clinical Practice Guide, consisting of general information about pregnancy (visits and monitoring of pregnancy, diet, phases of delivery, lactation, etc.), as well as specific recommendations for lumbopelvic pain associated with pregnancy. These contents will be developed by midwives from the participating hospitals. Participants will receive 12 educational sessions, with an estimated duration of 10 minutes each.
Intervention Type
Other
Intervention Name(s)
Pain neuroscience education
Intervention Description
The patients in the intervention group will receive, in addition to the prenatal educational content, the 12 Pain neuroscience education lessons in audiovisual format. Each lesson will last between 10-15 minutes. The contents of PNE will be an adaptation, focused on the context of a pregnant woman, of the Butler & Moseley postulates. These contents have already been previously adapted according to the nature of the patients' pain, both in chronic pain and in acute pain. In summary, the participants will receive a detailed explanation about the biopsychosocial component of pain through the use of diagrams, metaphors and practical examples. In turn, the objectives of this program could be summarized as: (1) Reformulate erroneous beliefs about pain, (2) Inform about the biology and protective nature of pain and (3) Provide techniques to reduce kinesiophobia and, consequently, promote physical activity, with the beneficial effect it entails for patients with pain.
Primary Outcome Measure Information:
Title
Pain intensity
Description
The primary outcome will be mean pain intensity over the previous week assessed using an 11-point numerical rating scale (range, 0 [no pain] to 10 [worst pain imaginable]).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Disability
Description
The Roland Morris questionnaire will be used. This is a validated questionnaire for the Spanish population and has previously been used in women with lumbopelvic pain. The questionnaire assesses the degree of physical disability in patients with non-specific low back pain and is made up of 24 items that describe daily activities that may be difficult to perform due to low back pain. A point is added to each item marked "yes", and a maximum score of 24 points can be obtained. The greater the number of positive responses, the greater the disability.
Time Frame
4 weeks
Title
Kinesiophobia
Description
The short version of the Tampa TSK-11 kinesiophobia scale will be used The Spanish version of this scale has been validated in patients with acute and chronic low back pain. The scale consists of 11 items, in which each item receives a score from 1 to 4 on the Likert scale (1=strongly disagree; 4=strongly agree). The score ranges from 11 to 44 points, with higher scores indicating a greater fear of movement.
Time Frame
4 weeks
Title
Pain catastrophizing
Description
The pain catastrophizing scale is an instrument made up of 13 items (each item scores between 0 and 4), which measures the degree to which patients develop feelings and thoughts related to their nociceptive experience. This scale, which has a validated version for Spanish, shows adequate internal consistency.
Time Frame
4 weeks
Title
Appreciation of body functionality
Description
It will be measured using the Functionality Appreciation Scale (FAS). This questionnaire consists of 7 items scored on a Likert-type scale of 1 (very disagree) to 5 (strongly agree). Higher scores reflect a greater appreciation of functionality. Appreciation of body functionality is one of the dimensions of the concept of positive body image that focuses not on appearance, but on in the perception of the body's capabilities and its unconditional acceptance.There is preliminary evidence indicating that the appreciation of body functionality may be a relevant component in the context of low back pain, with patients with worse results on this scale showing worse evolution of their pain with respect to controls.To the best of our knowledge, this dimension has not been assessed in any study of low back pain in pregnant women.
Time Frame
4 weeks
Title
Body Vigilance
Description
It will be measured using the Body Vigilance subscale of the Objectified Body Consciousness Scale questionnaire. This subscale is based on the premise that women are the object of constant attention by virtue of the appearance of their bodies (objectification), and that this leads them to permanent self-monitoring of their bodies to ensure that they conform to the canons of dominant beauty. The negative effects that the experience of self-objectification can produce in women are known, affecting not only their psychological state, but also consequently their physical state. A 2011 study of pregnant women found that increased body surveillance was associated with depressive symptoms and consequently unhealthy prenatal behaviors. However, the implications that could exist between this relationship and the appearance and maintenance of non-specific low back pain in pregnant women have not been studied to date.
Time Frame
4 weeks
Title
Anxiety and depression
Description
The Hospital Anxiety and Depression Scale (HADS) questionnaire will be used. This consists of 14 questions, of which 7 assess symptoms of anxiety (HADS-A) and 7 measure symptoms of depression (HADS-D). Each item scores from 0 to 3, with a score range in each subscale from 0-21. Scores of 0-7 indicate no anxiety or depression; scores between 8-10 indicate medium levels; scores of 11-14 indicate moderate levels and scores of 15-21 indicate severe levels of anxiety or depression. The HADS scale has good internal consistency, reliability, and validity.
Time Frame
4 weeks
Title
Level of physical activity
Description
The abbreviated version of the international physical activity questionnaire (International Physical Activity Questionnaire - IPAQ - short) will be used. This is a self-administered questionnaire consisting of 7 items and collecting information on physical activity performed in the last 7 days. This questionnaire has been previously validated in 12 countries and shows adequate psychometric properties. The short version (IPAD-SF) has shown acceptable validity in the Spanish adult population.
Time Frame
4 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
pregnant women older than 18 years, who are in the early third trimester of pregnancy;
minimum score of 3/10 on the numerical pain scale over the past week.
Exclusion Criteria:
multiple pregnancy;
previous spinal surgery;
presence of psychiatric disorders;
women who have participated in similar programs or interventions before enrollment.
Facility Information:
Facility Name
JF Lisón
City
Alfara del Patriarca
State/Province
Valencia
ZIP/Postal Code
46113
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JF Lisón, Dr
Phone
0034606503108
Email
juanfran@uchceu.es
First Name & Middle Initial & Last Name & Degree
Vicent Benavent, Dr
Phone
961369000
Ext
64349
Email
vicent.benavent@uchceu.es
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Online Intervention Based on Pain Neuroscience Education for Women With Pregnancy-related Lumbopelvic Pain
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