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

NCT05976854 | Completed

• 1 other identifier: UNIVERSITY CARDENAL HERRERA-65
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Disability

  4 weeks

• Kinesiophobia

  4 weeks

• Pain catastrophizing

  4 weeks

• Anxiety and depression

  4 weeks

• Level of physical activity

  4 weeks

Study Arms (2)

Pain neuroscience education (PNE)

EXPERIMENTAL

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.

Other: Pain neuroscience education; Other: Prenatal education

Prenatal education (PE)

OTHER

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.

Other: Prenatal education

Interventions

Pain neuroscience education 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.

Pain neuroscience education (PNE)

Prenatal education 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.

Pain neuroscience education (PNE); Prenatal education (PE)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• multiple pregnancy;
• previous spinal surgery;
• presence of psychiatric disorders;
• women who have participated in similar programs or interventions before enrollment.

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

JF Lisón

Alfara del Patriarca, Valencia, 46113, Spain

Location

Related Publications (1)

• Garcia-Lucas C, Chen E, Serrano-Raya L, Boldo-Roda A, Arguisuelas MD, Suso-Marti L, Pardo J, Amer-Cuenca JJ, Lison JF, Bivia-Roig G. Association between lumbopelvic pain in pregnancy and fear of childbirth: a multicenter cross-sectional case-control study. BMC Pregnancy Childbirth. 2025 Nov 17;25(1):1215. doi: 10.1186/s12884-025-08425-y.

  PMID: 41250063 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Prenatal Education

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Education as Topic; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: August 10, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

ES (1)