Clinical trial NCT05921747: The Impact of Innovative Technology Strategies on Implementing Exercise Programs Using Fully Immersive Virtual Reality for Postpartum Women
Official title: The Impact of Innovative Technology Strategies on Implementing Exercise Programs Using Fully Immersive Virtual Reality for Postpartum Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Partum Lumbopelvic Pain
Lead sponsor: Shalamar Institute of Health Sciences
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 34
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After selecting the desired sample size (tentative 17) the subjects will be randomly allocated to the both treatment groups
Primary purpose: TREATMENT

Brief summary: The study aims to determine the effect of core stability exercise through using fully immersive virtual reality in postpartum female with lumbopelvic pain.

This study will be randomized clinical -trial and will be conducted at Shalamar Institute of health sciences in 1 year after the approval by institutional review board. Sixty female participants with a history of lumbopelvic pain will be recruited on the basis of inclusion and exclusion criteria. Data will be collected after taking written Informed Consent from each patient. The included participants will be randomized by gold fish randomization method and allocated to two groups (A \& B) each with 30 participants.

Detailed description: Lumbopelvic pain refers to self-reported pain in the lower back, sacroiliac joints, or a combination of these locations, among pregnant and postnatal women. Approximately 50% of pregnant women report lumbopelvic pain to some degree. Recent studies indicate the importance of hip extensors, pelvic floor muscle (PFM) and transverse abdominal muscle (TrAM) in the development of lumbopelvic pain.Moreover, pelvic instability, asymmetry and insufficient compression of the sacroiliac joints contribute to continuous lumbopelvic pain after delivery. In Europe every tenth women shortly postpartum and every sixth has reported similar symptoms 6 weeks later. Age, PGP during pregnancy and abdominal midline doming were associated with experiencing PGP shortly postpartum.

Studies have demonstrated the importance of choosing an optimal treatment strategy in clinical practice, and 5 subgroups of self-rated pain locations have been identified in the pelvic area. The study focused on pelvic girdle pain (PGP), or PGP in combination with lumbar pain, since these groups have been shown to have the highest impact on activity levels and health-related quality of life.

Stabilization exercises that include dynamically controlling the lumbar segments and pelvic joints have been shown to result in functional improvement in patients with lumbopelvic pain. The term "core stability" is commonly used to refer to the ability of these "core" muscles to stabilize the lumbar spine and pelvic girdle during static postures and dynamic movements. A host of theories and "stabilization exercise" programs have been developed to train these muscles as a means of treating and/or preventing lower back pain (LBP). However, there is still much inconsistency and debate both in the clinical and research communities with regards to what constitutes "core stability" and a "stabilization exercise". Chronic pain is a global healthcare burden with as much as of 11% of the US population suffering from pain lasting six months or longer, and upwards of 20% in Europe. Chronic pain can lead to depression, anxiety, sleep disturbances, and impairment in cognitive tasks.

Established research supports VR(virtual relaity) as a treatment strategy for burn pain, acute pain, and experimentally induced pain. Two primary approaches afford analgesic benefits of VR: distraction therapy and immersive-ness. Distraction therapy temporarily takes attention away from pain while patients are engaged in the VR experience. In immersive VR, the user can interact with an artificial environment to treat chronic pain. In immersive VR, the user can interact with an artificial environment to treat chronic pain. One form of immersive VR is virtual embodiment. Virtual embodiment refers to the sense of owning a virtual body, from a first-person perspective, feeling the agent of the sensory feedback related to the actions of the virtual body. Through activation of somatosensory and premotor circuitry associated with the body parts that are embodied, the use of virtual embodiment as an immersive VR technique has been shown to influence pain-free range of motion in patients with unilateral chronic shoulder pain.

A case series was conducted in 2020, in which they describe two case studies that use embodiment in virtual reality as a treatment for chronic low back pain. The purpose of this case series was to determine the feasibility of a novel virtual reality-based digital therapeutic for the treatment of chronic pain. Two patients with chronic low back pain received seven sessions, two sessions per week, of a novel digital therapeutic that combines virtual embodiment with graded motor imagery to deliver functional rehabilitation exercises using an off-the-shelf virtual reality system. Pain catastrophizing scale was assessed before the first session and after the seventh session to determine the extent to which virtual embodiment training can improve psychological symptoms of chronic low back pain. In both patients, pain intensity was improved after individual sessions of virtual embodiment training. They concluded that embodiment in virtual reality improves symptoms of persistent chronic low back pain.

A study (RCT) was conducted in 2022 and their study have measured the Effects of a motor control exercise program on lumbopelvic pain recurrences and intensity in pregnant women with a history of lumbopelvic pain. Forty pregnant women with a history of lower back pelvic pain (LBPP) were recruited and randomly allocated to a control (20 participants) or intervention (20 participants) group. The control group have received standard prenatal care, including basic information on what to do when suffering from LBPP. The intervention group have participated in three 40-min exercise sessions per week from \< 20 weeks until 34-36 weeks of gestation: one supervised group session via the Zoom platform (once a month) and two unsupervised sessions at home. A motor control exercise program was developed to target strengthening of the lumbo-pelvic-hip core muscles and to improve spinal and pelvic stabilization. Participants of this group have also received standard prenatal care. They concluded that motor control exercise program have allowed pregnant women to progress at their own pace through different levels of exercises. In addition, the use of technology in the follow-up of the women will make the approach flexible and adapted to their daily routines.

The purpose of the study is to reduce the potential abuse, dependency of painkillers and manual therapy intervention for treating chronic lumbopelvic pain. In order to promote an advance and noninvasive method for treating lumbopelvic pain in postpartum female this study will help to design better rehabilitative program including core stability exercise using the analgesic and distracting effects of Immersive Virtual reality. This study will help physiotherapist as well as other health care professionals to treat other factors contributing to lumbopelvic pain other than weak muscles and posture alignment in postpartum female through virtual reality.

Eligibility criteria: Inclusion Criteria:

* Postpartum women with acute and chronic lumbopelvic pain.
* Primary parous \& multiparous women.

Exclusion Criteria:

* Postpartum women with nausea, dizziness and blurred vision, high risk pregnancies.
* Structural disorder of spinal alignment (Scoliosis, kyphosis, lordosis)
* Traumatic/ Inflammatory / Infectious Conditions
* Diagnosed stress / depression
* History of spinal, pelvic, or femur surgery or previous fracture, neoplasm
* Any Previous history of backache

Primary outcomes:
measure: Effect on lumbopelvic pain
timeFrame: Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment.
measure: Effect on disability due to lumbopelvic pain
timeFrame: Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment.
measure: Effect on disability due to pelvic pain
timeFrame: Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment.
measure: Effect on functioning
timeFrame: Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment.
measure: Level of Depression, anxiety & stress
timeFrame: Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment.
measure: To access intensity of Pain
timeFrame: Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment.
measure: condition-specific measure for women with pelvic girdle pain
timeFrame: Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment.
Secondary outcomes:
measure: Level of Urinary incontinence
timeFrame: Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment.
measure: To access fear of movement
timeFrame: Baseline (Day 0) and Follow up 1 (Day 1), Follow Up 2, (Day 8)
measure: Psychological assessment (Rumination, Magnification &Helplessness)
timeFrame: Baseline (Day 0) and Follow up 1 (Day 1), Follow Up 2, (Day 8)
Other outcomes:
measure: Presence of Vestibular basilar artery insufficiency (VBI)
timeFrame: Pre Treatment one time (Day 0)
measure: Presence of Simulator Sickness
timeFrame: Baseline (Day 0) and Follow up 1 (Day 1), Follow Up 2, (Day 8)
Locations:
city: Lahore
country: Pakistan
facility: Shalamar School of Allied Health Sciences
state: Punjab
Study officials:
affiliation: Shalamar Institute of Health Sciences
name: Javeria Dr Aslam, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Universided Europea Madrid, Spain
name: Carlos R. Morales, Ph.D
role: STUDY_DIRECTOR
affiliation: Universided Europea Madrid, Spain
name: RAQUEL DIAZ-MECO, Ph.D
role: STUDY_DIRECTOR
affiliation: Department of Radiology & Physical Medicine, Complutense University of Madrid, Spain
name: Alba P. Alemany, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vesentini G, Prior J, Ferreira PH, Hodges PW, Rudge M, Ferreira ML. Pelvic floor muscle training for women with lumbopelvic pain: A systematic review and meta-analysis. Eur J Pain. 2020 Nov;24(10):1865-1879. doi: 10.1002/ejp.1636. Epub 2020 Sep 6.
citation: Daneau C, Abboud J, Marchand AA, Houle M, Pasquier M, Ruchat SM, Descarreaux M. Mechanisms Underlying Lumbopelvic Pain During Pregnancy: A Proposed Model. Front Pain Res (Lausanne). 2021 Dec 2;2:773988. doi: 10.3389/fpain.2021.773988. eCollection 2021.
citation: Catena RD, Wolcott WC. Self-selection of gestational lumbopelvic posture and bipedal evolution. Gait Posture. 2021 Sep;89:7-13. doi: 10.1016/j.gaitpost.2021.06.022. Epub 2021 Jun 26.
citation: Starzec-Proserpio M, Wegrzynowska M, Sys D, Kajdy A, Rongies W, Baranowska B. Prevalence and factors associated with postpartum pelvic girdle pain among women in Poland: a prospective, observational study. BMC Musculoskelet Disord. 2022 Oct 20;23(1):928. doi: 10.1186/s12891-022-05864-y.
citation: Saleh MSM, Botla AMM, Elbehary NAM. Effect of core stability exercises on postpartum lumbopelvic pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(2):205-213. doi: 10.3233/BMR-181259.
citation: Ehsani F, Sahebi N, Shanbehzadeh S, Arab AM, ShahAli S. Stabilization exercise affects function of transverse abdominis and pelvic floor muscles in women with postpartum lumbo-pelvic pain: a double-blinded randomized clinical trial study. Int Urogynecol J. 2020 Jan;31(1):197-204. doi: 10.1007/s00192-019-03877-1. Epub 2019 Apr 23.
citation: Sonmezer E, Ozkoslu MA, Yosmaoglu HB. The effects of clinical pilates exercises on functional disability, pain, quality of life and lumbopelvic stabilization in pregnant women with low back pain: A randomized controlled study. J Back Musculoskelet Rehabil. 2021;34(1):69-76. doi: 10.3233/BMR-191810.
citation: Trujillo MS, Alvarez AF, Nguyen L, Petros J. Embodiment in Virtual Reality for the Treatment of Chronic Low Back Pain: A Case Series. J Pain Res. 2020 Nov 25;13:3131-3137. doi: 10.2147/JPR.S275312. eCollection 2020.
citation: Luo Y, He L, Li Y, Xie J, Gong S, Zhang Q, Yin E, Gu M, Yi C. Sacral osteotomy combined with triangular osteosynthesis in the treatment of malunion and nonunion of vertically displaced pelvic fractures. J Orthop Surg Res. 2022 Sep 5;17(1):409. doi: 10.1186/s13018-022-03296-x.
citation: Matamala-Gomez M, Slater M, Sanchez-Vives MV. Impact of virtual embodiment and exercises on functional ability and range of motion in orthopedic rehabilitation. Sci Rep. 2022 Mar 23;12(1):5046. doi: 10.1038/s41598-022-08917-3.
citation: Daneau C, Marchand AA, Bussieres A, O'Shaughnessy J, Ruchat SM, Descarreaux M. Effects of a motor control exercise program on lumbopelvic pain recurrences and intensity in pregnant women with a history of lumbopelvic pain: a study protocol for a randomized controlled feasibility trial. Pilot Feasibility Stud. 2022 Mar 21;8(1):65. doi: 10.1186/s40814-022-01024-0.
citation: Beales D, Lutz A, Thompson J, Wand BM, O'Sullivan P. Disturbed body perception, reduced sleep, and kinesiophobia in subjects with pregnancy-related persistent lumbopelvic pain and moderate levels of disability: An exploratory study. Man Ther. 2016 Feb;21:69-75. doi: 10.1016/j.math.2015.04.016. Epub 2015 May 1.
citation: Kale, A.A. and Pathan, N.M., 2019. Effect of Core Stabilisation Exercises in Postnatal Women with Lumbo-Pelvic Instability. Indian Journal of Physiotherapy and Occupational Therapy, 13(2), p.19.