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

NCT04721639 | Completed

• 1 other identifier: PPL-SPHINX2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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).

Conditions

Chronic Low-back Pain

Keywords

Chronic Low back pain; Yoga therapy; Sphinx Pose Yoga (Salamba Bhujangasana).; Healthcare Providers; Substance P; Cortisol; Beta Endorphins

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Substance P

  3 Months

• Beta Endorphins

  3 Months

• Cortisol

  3 Months

• Quality of Life Score

  3 Months

• Physical Stress - Stress Score

  3 Months

Study Arms (2)

The experimental intervention (Sphinx Yoga Therapy)

EXPERIMENTAL

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

The control intervention (Usual Care)

NO INTERVENTION

In this Group, participants won't be receiving any intervention and provided with the usual care.

Interventions

Sphinx Yoga Therapy OTHER

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.

The experimental intervention (Sphinx Yoga Therapy)

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Karachi: lead

Study Sites (2)

Koohi Goth Women Hospital

Karachi, Sindh, Pakistan

Location

Koohi Goth Women Hospital

Karachi, Sindhi, 24740, Pakistan

Location

Related Publications (20)

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 22, 2021
• Study Start: January 30, 2021
• Primary Completion: January 15, 2023
• Study Completion: February 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)