Effects of Core Stability Exercises in Postpartum Female With Lumbopelvic Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Core Stability Exercises Using Fully Immersive Virtual Reality in Postpartum Female With Lumbopelvic Pain

Conditions
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Post Partum Lumbopelvic Pain

Intervention / Treatment
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* Other: Standard core stability exercise program
* Device: Off-the-shelf virtual reality system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After selecting the desired sample size (tentative 17) the subjects will be randomly allocated to the both treatment groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Core stability exercise by Physiotherapist<br>Postpartum women in this group will receive standard core stability exercise program (Bridging, Pelvic rotation, Abdominal Tuck in, Knee to chest and Squatting) under the supervision of physiotherapist. | Other: Standard core stability exercise program<br>* The core stability exercises included Bridging, Pelvic rotation, Abdominal Tuck in, Knee to chest and Squatting. Pre and post measurement will be taken before and after the session.<br>|
| Experimental: Core stability exercise by Virtual Reality<br>Postpartum patients with lumbopelvic pain will receive two sessions per week for a period of 4 weeks 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. The core stability exercises included Bridging, Pelvic rotation, Abdominal Tuck in, Knee to chest and Squatting. Pre and post measurement will be taken before and after the session. | Other: Standard core stability exercise program<br>* The core stability exercises included Bridging, Pelvic rotation, Abdominal Tuck in, Knee to chest and Squatting. Pre and post measurement will be taken before and after the session.<br>Device: Off-the-shelf virtual reality system<br>* HTC Vive (HTC Corporation, Bellevue, WA) VR Head-Mounted Display (110º field of view, 1080 × 1200 pixels/eye, 90 Hz refresh) along with the Vive hand controllers and trackers to provide an immersive VR experience. The Vive Tracker can be used to track limb and trunk position and motion while in a VR experience. This setup will be paired with a gaming computer with the power to run a VR experience at a high frame rate to mitigate the risk of motion sickness. KVET™( Karuna Virtual Embodiment Training) consists of 10-30 minute sessions of exercises in an embodied VR experience.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on lumbopelvic pain | During pregnancy, women go through several hormonal and biomechanical changes as well as neuromuscular adaptations which could explain the development of lumbopelvic pain. Pregnancy-related hormonal changes, characterized by an increase in relaxin, estrogen and progesterone levels, are potentially linked to hyperlaxity of ligament and joint instability, thus contributing to lumbopelvic pain. In addition, biomechanical changes induced by the growing fetus, can modify posture, load sharing and mechanical stress in the lumbar and pelvic structures. Finally, neuromuscular adaptations during pregnancy include an increase in the activation of lumbopelvic muscles and a decrease in endurance of the pelvic floor muscles. Short Form McGill Pain Questionnaire(SF-MPQ) will be used to determine the intensity of pain. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. | Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment. | 
| Effect on disability due to lumbopelvic pain | Due to physiological changes the pregnant female experience lumber pain. to determine lumber pain Oswestry Disability Index (ODI) will be used. ODI scale will include following levels for assessment 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled | Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment. | 
| Effect on disability due to pelvic pain | Pelvic Floor Disability Index ( PFDI) will be used to assesses the distress of pelvic organ prolapse (POP), anorectal and urinary symptoms in three subscales, respectively, Pelvic Organ Prolapse Distress Inventory (POPDI-6), Colorectal-Anal Distress Inventory (CRADI-8) and Urinary Distress Inventory (UDI-6) .The PFDI-20 has 20 items and 3 scales of your symptoms. All items use the following format with a response scale from 0 to 4. Scale Scores | Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment. | 
| Effect on functioning | Patient Specific Functional Scale(PSFS) will be used. This scale will nominate 3 to 5 activities that they are unable to do or having difficulty doing because of their injury or problem. These activities are rated on an 11-point scale, where 0 is unable to perform the activity and 10 is able to perform the activity at preinjury level. | Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment. | 
| Level of Depression, anxiety & stress | DASS (Depression anxiety stress scale)questionnaire will be used for assessment. The total score represents overall distress (0 to 30), with higher scores indicating more severe distress or a greater number of symptoms. Two subscales are presented: Anxiety-Stress: Items 1, 4, 6, 7, 8, 9 (raw score range = 0 to 18) Depression: Items 2, 3, 5, 10 (raw score range = 0 to 12) | Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment. | 
| To access intensity of Pain | Visual analog scale (VAS) will be used to determine the intensity of pain. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be') | Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment. | 
| condition-specific measure for women with pelvic girdle pain | Pelvic Girdle Questionnaire (PGQ) will be used .To calculate the total PGQ score, all scores are summarized and divided by the total possible score of 75 (maximum possible scores of 60 for activity and 15 for symptoms), subsequently recalculated to a percentage, resulting in percentage scores ranging from 0 (no disability) to 100 (severe disability). | Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Urinary incontinence | Urinary Distress Index will be used to access distress caused by urinary incontinence.UDI-6 scores more than 33.33 indicate higher distress caused by urinary incontinence symptoms. | Baseline (Day 0) and Follow up 1 (Day 30) after 8 sessions of treatment. | 
| To access fear of movement | Tampa scale of kinesiophobia (TSK). TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia | Baseline (Day 0) and Follow up 1 (Day 1), Follow Up 2, (Day 8) | 
| Psychological assessment (Rumination, Magnification &Helplessness) | Pain Catastrophizing Scale will be used for measurement. Patients are asked to rate the degree to which they have any of the thoughts described in the questionnaire using a 5-point Likert scale ranging from 0 (never) to 4 (always). The total score is the sum of the scores for the individual items, and ranges from 0 to 52. | Baseline (Day 0) and Follow up 1 (Day 1), Follow Up 2, (Day 8) |