Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-26 @ 4:45 PM
Study NCT ID:
NCT05571358
Status:
UNKNOWN
Last Update Posted:
2023-11-29
First Post:
2022-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality to Improve Low-back Pain and Pelvic Pain During Pregnancy
Sponsor:
University of Malaga
Organization:
Study Overview
Official Title:
Virtual Reality to Improve Low-back Pain and Pelvic Pain During Pregnancy for a Multicentre Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: