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

Chronic Low-back Pain Clinical Trial

— CLBP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721639
• Other study ID #: PPL-SPHINX2020
• Status: Completed
• Phase: N/A
• Start date: January 30, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2023
• Source: University of Karachi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 1, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Pakistan	Koohi Goth Women Hospital	Karachi	Sindhi
Pakistan	Koohi Goth Women Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
University of Karachi

Country where clinical trial is conducted

Pakistan, 

References & Publications (20)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	3 Months
Secondary	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	3 Months
Secondary	Cortisol	Change in the Cortisol level will be observed among the subjects enrolled in the experimental group as compared to the control group	3 Months
Secondary	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.	3 Months
Secondary	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.	3 Months

External Links

•   Study Protocol