Virtual Reality to Improve Low-back Pain and Pelvic Pain During Pregnancy

University of Malaga

Status: Not yet enrolling

Conditions: Pelvic Pain; Low Back Pain

Treatments: Device: Virtual Reality (Nature Trek)

Study type: Interventional

Funder types: Other

Identifiers

NCT05571358

VR - LBP

Details and patient eligibility

About

A large percentage of women suffer low back and pelvic pain both during and after pregnancy. There are several factors to which these complaints are attributed, even affecting their daily lives. It is identified that many of these women do not receive adequate health care, however, different physiotherapeutic interventions are recommended to alleviate these conditions, presenting moderate levels of evidence. Virtual reality (VR) is presented as a complementary and promising treatment method to physiotherapy for the improvement of fundamental variables such as perceived pain and pain avoidance. The main objective is to evaluate the efficacy of a combined VR and physiotherapy program of 4 weeks duration compared to a standard physiotherapy intervention in pregnant women with low back pain and pelvic pain for the improvement of pain avoidance, pain intensity, disability and functional level. As a secondary objective the investigators propose to investigate patient satisfaction with the VR intervention. This research will be carried out by means of a multicenter randomized controlled clinical trial in pregnant patients residing in the provinces of Seville and Malaga with a diagnosis of low back pain and pelvic pain during pregnancy. The alternative hypothesis of this research is that the implementation of a Virtual Reality program together with standard physiotherapy in pregnant patients with low back and pelvic pain presents better clinical results obtained with the current standard intervention, which may represent an opportunity to define new policies and interventions for these pathologies and their consequences.

Enrollment: 66 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult woman over 18 years old
• Pregnant woman with Low Back Pain, Pelvic Pain (PP) or both conditions with symptomatic character.
• Pregnant woman between the 12th and 36th week of gestation, corresponding to the 2nd and 3rd trimester.
• Pain intensity greater than 4/10 on VAS, indicating moderate-severe pain.
• Live in Sevilla or Malaga during the research period.

Exclusion criteria

• Patients with LBP or PP pain prior to pregnancy.
• Cognitive ability not suitable for the use of technological tools.
• Patients with absolute or relative contraindications.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Control Group

No Intervention group

Description:

Following clinical practice guidelines, subjects in the control group will receive multidisciplinary rehabilitation programmes with coordinated delivery of supervised exercise therapy, cognitive behavioural therapy (education on pain), as well as therapeutic massage to relieve low back pain during pregnancy.

Virtual Reality (Nature Trek)

Experimental group

Description:

* Subjects in the experimental group will receive the same treatment described for the control group. * Subjects in the experimental group will receive an additional Virtual Reality Intervention (VRi).

Treatment:

Device: Virtual Reality (Nature Trek)