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Chronic Low-back PainCLBPNCT04721639

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

A study testing Sphinx Yoga Therapy in people with Chronic Low-back Pain, run by University of Karachi at 2 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Low-back Pain
What is being tested?
Sphinx Yoga Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesPakistan
Study dates
30 Jan 2021to 1 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

None listed.

Who cannot join

  • 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).

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites

  • Koohi Goth Women Hospital

    Karachi, Sindh

  • Koohi Goth Women Hospital

    Karachi, Sindhi, 24740

Other trials in Pakistan

About this study

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

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).

Read the 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.
Being tested
Sphinx Yoga Therapy
Keywords
Chronic Low back pain, Yoga therapy, Sphinx Pose Yoga (Salamba Bhujangasana)., Healthcare Providers, Substance P, Cortisol, Beta Endorphins

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sphinx Yoga TherapyOther

    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.

Study groups in NCT04721639
Study groupRoleWhat they receive
The experimental intervention (Sphinx Yoga Therapy)ExperimentalIn 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).
Receives: Other: Sphinx Yoga Therapy
The control intervention (Usual Care)No interventionIn this Group, participants won't be receiving any intervention and provided with the usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 Months

  2. 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."

    Measured: 3 Months

Secondary outcomes (5)

  1. 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

    Measured: 3 Months

  2. 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

    Measured: 3 Months

  3. Cortisol

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

    Measured: 3 Months

  4. 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.

    Measured: 3 Months

  5. 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.

    Measured: 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start30 Jan 2021
  3. Primary completion15 Jan 2023
  4. Study completion1 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04721639
Sponsor's protocol ID
PPL-SPHINX2020
Acronym
CLBP
Status last verified
Feb 2023
First submitted
20 Jan 2021
Last updated
8 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30233114

  • 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.

    PubMed 20356395

  • 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.

    PubMed 28076926

  • 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.

    PubMed 28631003

  • 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.

    PubMed 27231715

  • 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.

    PubMed 23298422

  • 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.

    PubMed 15055095

  • 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.

    PubMed 28895982

  • 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.

    PubMed 27176750

  • 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.

    PubMed 27858698

  • 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.

    PubMed 30922383

  • 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.

    PubMed 30256990

  • 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.

    PubMed 1688690

  • 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.

    PubMed 29459715

  • 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.

    PubMed 21602759

Questions about this trial

What is this clinical trial studying?

A study testing Sphinx Yoga Therapy in people with Chronic Low-back Pain, run by University of Karachi at 2 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extent of Disability (time frame: 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04721639, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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