To Observe the Effect of Sphinx Pose (Salamba Bhujangasana) Among Health Care Providers With Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
This Randomized Controlled trial is designed to observe the effect of Sphinx Yoga (Salamba Bhujangasana) on low back pain and variation in the associated physiological parameters that help explain the beneficial effects of yoga, among healthcare providers of Karachi Pakistan. Healthcare providers with LBP (determined as per the baseline assessment) will be recruited and Substance P and Beta Endorphins will be assessed at baseline and after 3 months. The subjects with LBP will be determined based on the scores of the Oswestry Low Back Pain Disability Questionnaire, Numerical Pain Rating (NPR) scale, Roland Morris Disability Questionnaire (RMDQ) and Fear Avoidance Beliefs Questionnaire (FABQ) work subscale. Subjects meeting eligibility criteria will be randomly allotted to intervention and control groups. The study outcomes will be monitored in subjects of both groups at baseline and after 3-month follow-up (post-interventional).

Detailed Description
-----------------
Plan of work Assessment of eligibility & Enrollment: HCPs experiencing LBP as per the eligibility criteria will be enrolled. Baseline Assessment: All the variables, i.e. Oswestry Low Back Pain Disability Questionnaire, World Health Organization Quality of Life (WHOQOL), Roland Morris Disability Questionnaire (RMDQ) and Sadaf Stress Scale (SSS), Substance-P and Beta Endorphins will be measured at baseline. Randomization & Allocation: Eligible consenting subjects will be randomly allocated to the experimental or control group. Follow-up Assessment: All the outcome measures observed at baseline will be re-assessed after 3 months. Statistical Analysis: Pre & post-analysis will be conducted. Study design The study will be conducted as a Randomized Controlled trial at a primary healthcare setting. The participant eligibility will be assessed using a pre-screening questionnaire including components of disability questionnaires. Based on the eligibility criteria, consenting HCPs will be recruited and randomized into two groups i.e. Group A (experimental) including participants who will receive the intervention and Group B (control) receiving no intervention. The study outcomes will be monitored among participants of both groups at baseline and post-intervention (3-month follow-up). Participants Healthcare providers with LBP will be recruited with no restriction for ethnicity or race. The participants from diverse socio-cultural backgrounds will be considered eligible if they meet the inclusion criteria. The study objective will be explained and participants will be invited to participate based on their free-will. Sampling Size The required sample size for the two study groups with α = 0.05 and (1- α) = 0.80, was estimated to be 49 in each group i.e. the total sample size was 98 for two groups. The sample size calculator provided by the UCSF CTSI was used. Randomization After assessing the eligibility the participants will be randomly allocated in the ratio of 1:1 to the study groups (experimental and control). The randomization sequence will be computer-generated. After acquiring the basic information, a unique code will be assigned to each of the study participants which will then be mentioned in their Performa. Interventions • The experimental intervention: The Group A participants will be intervened with Sphinx Yoga therapy which will take place in a conserved therapy center of Koohi Goth Hospital. This stretching exercise session will take place in the afternoon and for a duration of 10 minutes followed by 30 minutes therapy session five times per week (total 12 weeks). • The control intervention: Group B participants won't be receiving any intervention and provided with the usual care.

Official Title
-----------------
Effect of Sphinx Pose (Salamba Bhujangasana) Among Health Care Providers With Chronic Low Back Pain: A Randomized Controlled Trial.

Conditions
-----------------
Chronic Low-back Pain

Intervention / Treatment
-----------------
* Other: Sphinx Yoga Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects must meet all the requirements as follow: Subjects of both genders between 25 to 45 years of age. They must score more than or equal to 2 for their pain intensity in the last week, on the Numerical Pain Rating (NPR) scale (0-10) On Roland Morris Disability Questionnaire participant's score should be ≥ 4. Fear Avoidance Beliefs Questionnaire (FABQ) work subscale score must be less than 19. They have visited the health care provider in recent days for their back pain. Exclusion Criteria: Subjects with a personal history of neurological disorders including Alzheimer's, amyotrophic lateral sclerosis, multiple sclerosis, Parkinson's and stroke, any cardio-respiratory disorders like congestive heart failure, heart attack in the past 24 months and/or musculoskeletal disorders like rheumatoid arthritis, pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis. Including a history of spine surgery or hip arthroplasty. Those subjects who have used narcotics or muscle relaxants within 30 days prior to study enrollment. Pregnant and/or lactating females. Those having body mass index > 35 kg/m2 or presented with unexplained weight loss over the past month (>10 lbs). Clinically depressed subjects (i.e., subjects who score 24 or higher on the Center for Epidemiology Depression Scale).

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The experimental intervention (Sphinx Yoga Therapy)<br>In this group, participants will be intervened with Sphinx Yoga therapy which will take place in a conserved therapy center of Koohi Goth Hospital. This stretching exercise session will take place in the afternoon and for a duration of 10 minutes followed by 30 minutes therapy session five times per week (total 12 weeks). | Other: Sphinx Yoga Therapy<br>* Sphinx Pose Yoga is among the best beginner Yoga Poses that relieve Lower Back Pain. It extends the back gently and activates muscles along the spine. The subject will be asked to lay down on their stomach with feet set hip-width apart, the elbows positioned under the shoulders, and the legs held together. The chin should be pointing towards the floor. Next, the subject is required to pull up the kneecaps, squeezing the thighs and buttocks, pressing the pubic bone into the floor and dropping shoulders back away from the neck and pushing the chest forward. In this position, the subject is asked to breathe and hold the pose for two to six breaths. By the end, the subject will be required to exhale, bringing the elbows to the sides and slowly lowering the chest and head to the floor.<br>|
| No Intervention: The control intervention (Usual Care)<br>In this Group, participants won't be receiving any intervention and provided with the usual care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extent of Disability | Change in the Oswestry Disability Index will be observed among the subjects enrolled in the experimental group after intervention. The Oswestry Low Back Pain Disability Questionnaire, is considered as a standard to assess the functionality of low back. It is considered a gold standard tool for evaluating the extent of disability. | 3 Months | 
| Pain Score | It will be assessed with the help of Numeric Pain Rating scale. The numeric rating scale is a pain screening tool that is frequently used to evaluate the current level of pain using a 0-10 scale, where 0 corresponds to no pain and 10 to the greatest pain possible. | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance P | Change in the Substance P level will be observed among the subjects enrolled in the experimental group as compared to the control group | 3 Months | 
| Beta Endorphins | Change in the Beta Endorphins level will be observed among the subjects enrolled in the experimental group as compared to the control group | 3 Months | 
| Cortisol | Change in the Cortisol level will be observed among the subjects enrolled in the experimental group as compared to the control group | 3 Months | 
| Quality of Life Score | Change in World Health Organization Quality of Life (WHOQOL) from baseline to post-intervention assessment. It will help in the evaluation in changes observed in the well-being of the patient, before and after the intervention is given. | 3 Months | 
| Physical Stress - Stress Score | SSS was established for stress evaluation by observing major signs & symptoms, and classification of these symptoms into seven different classes47. Physical stress, sub-section of SSS will be used to assess the degree of stress and its contribution in LBP. | 3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Low back pain, Yoga therapy, Sphinx Pose Yoga (Salamba Bhujangasana)., Healthcare Providers, Substance P, Cortisol, Beta Endorphins