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

Last updated: November 28, 2023
Sponsor: University of Malaga
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Dysmenorrhea (Painful Periods)

Chronic Pain

Treatment

Virtual Reality (Nature Trek)

Clinical Study ID

NCT05571358
VR - LBP
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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.

Study Design

Total Participants: 66
Treatment Group(s): 1
Primary Treatment: Virtual Reality (Nature Trek)
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2024