To Observe the Effect of Sphinx Pose (Salamba Bhujangasana) Among Health Care Providers With Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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.
    

Intervention name(s): Sphinx Yoga Therapy
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Chronic Low back pain; Yoga therapy; Sphinx Pose Yoga (Salamba Bhujangasana).; Healthcare Providers; Substance P; Cortisol; Beta Endorphins