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

NCT ID: NCT05976854

Last Updated: 2024-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2024-11-01

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pain neuroscience education (PNE)

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.

Group Type: EXPERIMENTAL

Pain neuroscience education

Intervention Type: OTHER

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.

Prenatal education

Intervention Type: OTHER

The standard prenatal education is 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.

Prenatal education (PE)

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.

Group Type: OTHER

Prenatal education

Intervention Type: OTHER

The standard prenatal education is 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.

Interventions

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.

Intervention Type: OTHER

Prenatal education

The standard prenatal education is 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

Juan F. Lisón Párraga, Dr

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

JF Lisón

Alfara del Patriarca, Valencia, Spain

Countries

Spain

Other Identifiers

UNIVERSITY CARDENAL HERRERA-65

Identifier Type: -

Identifier Source: org_study_id