Online Intervention Based on Pain Neuroscience Education for Women With Pregnancy-related Lumbopelvic Pain

Low Back Pain Clinical Trial

Official title:

Effects of an Online Intervention Based on Pain Neuroscience Education for Women With Pregnancy-related Lumbopelvic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05976854
• Other study ID #: UNIVERSITY CARDENAL HERRERA-65
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: February 10, 2025

Study information

• Verified date: June 2024
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: February 10, 2025
• Est. primary completion date: February 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Low Back Pain

Intervention

Other:
• Pain neuroscience education
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.

Locations

Country	Name	City	State
Spain	JF Lisón	Alfara del Patriarca	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]).	4 weeks
Secondary	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.	4 weeks
Secondary	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.	4 weeks
Secondary	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.	4 weeks
Secondary	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.	4 weeks
Secondary	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.	4 weeks
Secondary	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.	4 weeks
Secondary	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.	4 weeks