The study aims to determine the effect of traditional exercise through using fully immersive virtual reality in postpartum female with lumbopelvic pain. This study will be single-blind 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.
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. Traditional 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
34
Standard Traditional exercise program: The traditional exercises will include Kegel pelvic floor exercise, dead weight lifts, wide back rows, lunges with rotation, good morning (hip hinge), and lateral side bends. . Pre and post measurement will be taken before and after the session.
Participants in the intervention group will undergo a virtual reality (VR)-based exercise program using Meta Quest 2 head-mounted displays (Meta Platforms Inc., USA) and the Lumbar Pain Rehab software provided by DynamicsVR (Dynamics VR S.L., Cadiz, Spain). The virtual reality (VR) intervention will consist of eight structured sessions designed to address postpartum lumbo-pelvic pain through the immersive, interactive training. Each session incorporating pelvic floor muscle training using VR, consisting of three sets of 12 repetitions, with each contraction and relaxation phase lasting three seconds. In addition, patients engaged in two five-minute blocks of immersive VR activities with a two-minute rest interval, resulting in total session duration of 18 minutes. A familiarization session will be conducted prior to the intervention to acclimate participants to the VR environment. This will include modified pelvic floor training (3 sets of 8 repetitions; 3 seconds of contraction.
Shalamar School of Allied Health Sciences
Lahore, Punjab Province, Pakistan
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')
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
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.
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
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.
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
Presence of Simulator Sickness
Simulator Sickness Questionnaire (SSQ) will be used for assessment .The overall support score (SSQN) is calculated by taking an average of the individual scores across the 27 items. A high score on the SSQ indicates more optimism about life than a low score. Respondents with low SSQ scores have a higher prevalence of negative life events and illness.
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
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).
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
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
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
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
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
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
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
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)
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
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.
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
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.
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
coping strategy of pain
Pain coping strategies were measured using the Coping Strategies Questionnaire (CSQ), which assesses three domains: cognitive, emotional, and behavioral responses to pain. Items are recorded on a 0-6 scale, with higher values shows more frequent use of each coping strategy.
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
To access fatigue
Fatigue severity was evaluated using the fatigue severity scale (FSS), a 9-item self-report measure designed to capture the impact of fatigue on daily functioning. Although the original scale does not include categorical thresholds, the scale is sometimes interpreted as low (scores 1-4), medium or borderline (4-5), and high or severe (5-7). In the present study, scores between 1 and 4 were operationally defined as indicative of low fatigue.
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
To acess breathlessness
Breathlessness intensity was measured with the modified Borg dyspnoea scale(24) (0-10), a numerical rating tool used to quantify perceived breathlessness during or following physical activity, where 0 represents no breathlessness, and 10 denotes maximal breathlessness. A score of \<5 was used as an operational definition of moderate breathlessness.
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
To acess sleep quality and disturbance
Sleep quality and disturbances were assessed using the MOS Sleep Scale, a 12-item self-report questionnaire that evaluates sleep patterns over the previous four weeks. The scale generates six domain scores and two composite indices, each transformed to a 0-100 metric.
Time frame: Baseline (Day 0) , Follow up 1 (Day 30) after 8 sessions of treatment and follow up 2nd (day 60).
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