search
Back to results

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

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Sphinx Yoga Therapy
Sponsored by
University of Karachi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Low-back Pain focused on measuring Chronic Low back pain, Yoga therapy, Sphinx Pose Yoga (Salamba Bhujangasana)., Healthcare Providers, Substance P, Cortisol, Beta Endorphins

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Koohi Goth Women Hospital
  • Koohi Goth Women Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The experimental intervention (Sphinx Yoga Therapy)

The control intervention (Usual Care)

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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.
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."

Secondary Outcome Measures

Substance P
Change in the Substance P level will be observed among the subjects enrolled in the experimental group as compared to the control group
Beta Endorphins
Change in the Beta Endorphins level will be observed among the subjects enrolled in the experimental group as compared to the control group
Cortisol
Change in the Cortisol level will be observed among the subjects enrolled in the experimental group as compared to the control group
Quality of Life Score
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.
Physical Stress - Stress Score
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.

Full Information

First Posted
January 20, 2021
Last Updated
February 5, 2023
Sponsor
University of Karachi
search

1. Study Identification

Unique Protocol Identification Number
NCT04721639
Brief Title
To Observe the Effect of Sphinx Pose (Salamba Bhujangasana) Among Health Care Providers With Chronic Low Back Pain
Acronym
CLBP
Official Title
Effect of Sphinx Pose (Salamba Bhujangasana) Among Health Care Providers With Chronic Low Back Pain: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 30, 2021 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Karachi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Chronic Low back pain, Yoga therapy, Sphinx Pose Yoga (Salamba Bhujangasana)., Healthcare Providers, Substance P, Cortisol, Beta Endorphins

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The experimental intervention (Sphinx Yoga Therapy)
Arm Type
Experimental
Arm Description
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).
Arm Title
The control intervention (Usual Care)
Arm Type
No Intervention
Arm Description
In this Group, participants won't be receiving any intervention and provided with the usual care.
Intervention Type
Other
Intervention Name(s)
Sphinx Yoga Therapy
Intervention Description
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 Outcome Measure Information:
Title
Extent of Disability
Description
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.
Time Frame
3 Months
Title
Pain Score
Description
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."
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Substance P
Description
Change in the Substance P level will be observed among the subjects enrolled in the experimental group as compared to the control group
Time Frame
3 Months
Title
Beta Endorphins
Description
Change in the Beta Endorphins level will be observed among the subjects enrolled in the experimental group as compared to the control group
Time Frame
3 Months
Title
Cortisol
Description
Change in the Cortisol level will be observed among the subjects enrolled in the experimental group as compared to the control group
Time Frame
3 Months
Title
Quality of Life Score
Description
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.
Time Frame
3 Months
Title
Physical Stress - Stress Score
Description
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.
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Facility Information:
Facility Name
Koohi Goth Women Hospital
City
Karachi
State/Province
Sindhi
ZIP/Postal Code
24740
Country
Pakistan
Facility Name
Koohi Goth Women Hospital
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30233114
Citation
Patil NJ, Nagaratna R, Tekur P, Manohar PV, Bhargav H, Patil D. A Randomized Trial Comparing Effect of Yoga and Exercises on Quality of Life in among nursing population with Chronic Low Back Pain. Int J Yoga. 2018 Sep-Dec;11(3):208-214. doi: 10.4103/ijoy.IJOY_2_18.
Results Reference
background
PubMed Identifier
20356395
Citation
Sherman KJ, Cherkin DC, Cook AJ, Hawkes RJ, Deyo RA, Wellman R, Khalsa PS. Comparison of yoga versus stretching for chronic low back pain: protocol for the Yoga Exercise Self-care (YES) trial. Trials. 2010 Mar 31;11:36. doi: 10.1186/1745-6215-11-36.
Results Reference
background
PubMed Identifier
28076926
Citation
Wieland LS, Skoetz N, Pilkington K, Vempati R, D'Adamo CR, Berman BM. Yoga treatment for chronic non-specific low back pain. Cochrane Database Syst Rev. 2017 Jan 12;1(1):CD010671. doi: 10.1002/14651858.CD010671.pub2.
Results Reference
background
PubMed Identifier
28631003
Citation
Saper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, Stevans J, Keosaian JE, Cerrada CJ, Femia AL, Roseen EJ, Gardiner P, Gergen Barnett K, Faulkner C, Weinberg J. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017 Jul 18;167(2):85-94. doi: 10.7326/M16-2579. Epub 2017 Jun 20.
Results Reference
background
PubMed Identifier
27231715
Citation
Chang DG, Holt JA, Sklar M, Groessl EJ. Yoga as a treatment for chronic low back pain: A systematic review of the literature. J Orthop Rheumatol. 2016 Jan 1;3(1):1-8.
Results Reference
background
PubMed Identifier
23298422
Citation
Behisi MA, Al-Otaibi ST, Beach J. Back pain among health care workers in a Saudi Aramco facility: prevalence and associated factors. Arch Environ Occup Health. 2013;68(1):30-8. doi: 10.1080/19338244.2011.627895.
Results Reference
background
PubMed Identifier
15055095
Citation
Galantino ML, Bzdewka TM, Eissler-Russo JL, Holbrook ML, Mogck EP, Geigle P, Farrar JT. The impact of modified Hatha yoga on chronic low back pain: a pilot study. Altern Ther Health Med. 2004 Mar-Apr;10(2):56-9.
Results Reference
background
PubMed Identifier
28895982
Citation
Simsek S, Yagci N, Senol H. Prevalence of and risk factors for low back pain among healthcare workers in Denizli. Agri. 2017 Apr;29(2):71-78. doi: 10.5505/agri.2017.32549.
Results Reference
background
PubMed Identifier
27176750
Citation
Menzel N, Feng D, Doolen J. Low Back Pain in Student Nurses: Literature Review and Prospective Cohort Study. Int J Nurs Educ Scholarsh. 2016 May 13;13:/j/ijnes.2016.13.issue-1/ijnes-2015-0057/ijnes-2015-0057.xml. doi: 10.1515/ijnes-2015-0057.
Results Reference
background
PubMed Identifier
27858698
Citation
Cinar-Medeni O, Elbasan B, Duzgun I. Low back pain prevalence in healthcare professionals and identification of factors affecting low back pain. J Back Musculoskelet Rehabil. 2017;30(3):451-459. doi: 10.3233/BMR-160571.
Results Reference
background
PubMed Identifier
30922383
Citation
Mekonnen TH, Yenealem DG. Factors affecting healthcare utilization for low back pain among nurses in Gondar town, northwest Ethiopia, 2018: a cross-sectional study. BMC Res Notes. 2019 Mar 29;12(1):185. doi: 10.1186/s13104-019-4231-2.
Results Reference
background
PubMed Identifier
30256990
Citation
Choi HY, Lee CH. Can Beta-Endorphin Be Used as a Biomarker for Chronic Low Back Pain? A Meta-analysis of Randomized Controlled Trials. Pain Med. 2019 Jan 1;20(1):28-36. doi: 10.1093/pm/pny186.
Results Reference
background
PubMed Identifier
1688690
Citation
Parris WC, Kambam JR, Naukam RJ, Rama Sastry BV. Immunoreactive substance P is decreased in saliva of patients with chronic back pain syndromes. Anesth Analg. 1990 Jan;70(1):63-7. doi: 10.1213/00000539-199001000-00010.
Results Reference
background
PubMed Identifier
29459715
Citation
Jasim H, Carlsson A, Hedenberg-Magnusson B, Ghafouri B, Ernberg M. Saliva as a medium to detect and measure biomarkers related to pain. Sci Rep. 2018 Feb 19;8(1):3220. doi: 10.1038/s41598-018-21131-4.
Results Reference
background
PubMed Identifier
21602759
Citation
Murtezani A, Hundozi H, Orovcanec N, Sllamniku S, Osmani T. A comparison of high intensity aerobic exercise and passive modalities for the treatment of workers with chronic low back pain: a randomized, controlled trial. Eur J Phys Rehabil Med. 2011 Sep;47(3):359-66. Epub 2011 May 23.
Results Reference
background
PubMed Identifier
26444559
Citation
Lisowska B, Lisowski A, Siewruk K. Substance P and Chronic Pain in Patients with Chronic Inflammation of Connective Tissue. PLoS One. 2015 Oct 7;10(10):e0139206. doi: 10.1371/journal.pone.0139206. eCollection 2015.
Results Reference
background
PubMed Identifier
30116793
Citation
Kallman TF, Ghafouri B, Backryd E. Salivary beta-endorphin and substance P are not biomarkers of neuropathic chronic pain propensity. Heliyon. 2018 Aug 3;4(8):e00718. doi: 10.1016/j.heliyon.2018.e00718. eCollection 2018 Aug.
Results Reference
background
PubMed Identifier
30284083
Citation
Zieglgansberger W. Substance P and pain chronicity. Cell Tissue Res. 2019 Jan;375(1):227-241. doi: 10.1007/s00441-018-2922-y. Epub 2018 Oct 3.
Results Reference
background
PubMed Identifier
35191173
Citation
Noushad S, Ansari B, Ahmed S. Effect of nature-based physical activity on post-traumatic growth among healthcare providers with post-traumatic stress. Stress Health. 2022 Oct;38(4):813-826. doi: 10.1002/smi.3135. Epub 2022 Feb 26.
Results Reference
background
PubMed Identifier
34548863
Citation
Noushad S, Ahmed S, Ansari B, Mustafa UH, Saleem Y, Hazrat H. Physiological biomarkers of chronic stress: A systematic review. Int J Health Sci (Qassim). 2021 Sep-Oct;15(5):46-59.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs