Clinical trial NCT04721639: To Observe the Effect of Sphinx Pose (Salamba Bhujangasana) Among Health Care Providers With Chronic Low Back Pain
Official title: Effect of Sphinx Pose (Salamba Bhujangasana) Among Health Care Providers With Chronic Low Back Pain: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Chronic Low back pain
Yoga therapy
Sphinx Pose Yoga (Salamba Bhujangasana).
Healthcare Providers
Substance P
Cortisol
Beta Endorphins
Lead sponsor: University of Karachi
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Extent of Disability
timeFrame: 3 Months
measure: Pain Score
timeFrame: 3 Months
Secondary outcomes:
measure: Substance P
timeFrame: 3 Months
measure: Beta Endorphins
timeFrame: 3 Months
measure: Cortisol
timeFrame: 3 Months
measure: Quality of Life Score
timeFrame: 3 Months
measure: Physical Stress - Stress Score
timeFrame: 3 Months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Koohi Goth Women Hospital
state: Sindhi
city: Karachi
country: Pakistan
facility: Koohi Goth Women Hospital
state: Sindh
Study officials:
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