Clinical trial NCT05571358: Virtual Reality to Improve Low-back Pain and Pelvic Pain During Pregnancy
Official title: Virtual Reality to Improve Low-back Pain and Pelvic Pain During Pregnancy for a Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Pelvic Pain
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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.

Primary outcomes:
measure: The Fear-Avoidance Components Scale (FACS)
timeFrame: Baseline FACS
measure: The Fear-Avoidance Components Scale (FACS)
timeFrame: 4 weeks FACS
measure: Pain Intensity
timeFrame: Baseline
measure: Pain Intensity
timeFrame: 4 weeks
measure: Disability and Physical function
timeFrame: Baseline RMDQ
measure: Disability and Physical function
timeFrame: 4 weeks RMDQ
measure: Disability and Physical function
timeFrame: Baseline ODI
measure: Disability and Physical function
timeFrame: 4 weeks ODI
Secondary outcomes:
measure: Satisfaction with Virtual Reality intervention
timeFrame: Baseline USEQ
measure: Satisfaction with Virtual Reality intervention
timeFrame: 4 weeks USEQ
Other outcomes:
Locations:
Study officials:
References: