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NCT Number: NCT04721639

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

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).

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koohi Goth Women Hospital, Karachi, Sindh, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Extent of Disability

    Time frame: 3 Months

    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.

  2. Pain Score

    Time frame: 3 Months

    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."

Secondary outcomes

  1. Substance P

    Time frame: 3 Months

    Change in the Substance P level will be observed among the subjects enrolled in the experimental group as compared to the control group

  2. Beta Endorphins

    Time frame: 3 Months

    Change in the Beta Endorphins level will be observed among the subjects enrolled in the experimental group as compared to the control group

  3. Cortisol

    Time frame: 3 Months

    Change in the Cortisol level will be observed among the subjects enrolled in the experimental group as compared to the control group

  4. Quality of Life Score

    Time frame: 3 Months

    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.

  5. Physical Stress - Stress Score

    Time frame: 3 Months

    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.

Sponsors and collaborators

Lead sponsor

University of Karachi

Other

Registry information

Official study title

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

Acronym: CLBP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2021
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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