To Observe the Effect of Sphinx Pose (Salamba Bhujangasana) Among Health Care Providers With Chronic Low Back Pain
NCT ID: NCT04721639
Last Updated: 2023-02-08
Study Results
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Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2021-01-30
2023-02-01
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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The experimental intervention (Sphinx Yoga Therapy)
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).
Sphinx Yoga Therapy
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 control intervention (Usual Care)
In this Group, participants won't be receiving any intervention and provided with the usual care.
No interventions assigned to this group
Interventions
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Sphinx Yoga Therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
25 Years
45 Years
ALL
Yes
Sponsors
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University of Karachi
OTHER
Responsible Party
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Shamoon Noushad
Principal Investigator
Locations
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Koohi Goth Women Hospital
Karachi, Sindh, Pakistan
Koohi Goth Women Hospital
Karachi, Sindhi, Pakistan
Countries
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References
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Other Identifiers
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PPL-SPHINX2020
Identifier Type: -
Identifier Source: org_study_id
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