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Effectiveness of Cat-Cow Yoga in Managing Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04723225
Recruitment Status : Unknown
Verified January 2021 by Shamoon Noushad, University of Karachi.
Recruitment status was:  Not yet recruiting
First Posted : January 25, 2021
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Shamoon Noushad, University of Karachi

Brief Summary:
A randomized control trial is planned to investigate the effectiveness of Cat-Cow yoga as a treatment for chronic low back pain CLBP. An 12 weeks course of intervention will be provided to the candidates that will meet the eligibility criteria of the study. Substance P, beta endorphins and cortisol will be tested both the groups' pre and post treatment and then the difference from the baseline value will be determined.

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Other: Cat-Cow Yoga Not Applicable

Detailed Description:

A randomized control trial will be conducted. Subjects who have passed the eligibility criteria will be asked for their consent to participate in the study. Then they will be chosen into their groups randomly. Every individual will have a fair chance to be selected in the test group in which they will receive the intervention, while the control group will receive 'usual care'. The outcomes of the study will be examined before the intervention and after the intervention with an interval of 12 weeks.

Subjects for this study will be enrolled from different Health care professionals of Karachi, Pakistan. Participants of the study will have diverse ethnicity, culture, socio-economic status etc. participants will be considered eligible for the study if the meet all the requirements of the inclusion criteria. Subjects will be invited and motivated for their participation in the study through advertisement on the notice board of their office. Those who have volunteered for the study will be provided with a consent form with detailed description of the study about its aims, duration and expected outcomes.

Interventions

The experimental intervention (Cat-Cow Yoga):

The cat-cow yoga therapy will be conducted in a conserved therapy center in Karachi. Session will start with a 10 minutes of warm-ups followed by 30 minutes of the therapy session in the afternoon three days a week (total 12 weeks).

The control intervention:

In control group, subjects will be given the usual care that if not vanishes the pain completely; will provide relief from the pain for the time being. Subjects in the control group will be asked to maintain a proper posture, take breaks during the work, remain active and to apply superficial heat if their pain exceeds their tolerance level.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: To Observe The Effectiveness Of Cat-Cow Yoga In The Pain Management Of Chronic Low Back Pain In Health Care Professionals
Estimated Study Start Date : January 30, 2021
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : October 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Experimental
Cat-Cow is one of the essential postures in yoga for its beneficial reasons. It is an alternate shift of posture from flexion of the back (rounded) to the extension of the back (arched). During each set of movement, inhalation and exhalation will be guided.
Other: Cat-Cow Yoga
Cat-Cow is one of the essential postures in yoga for its beneficial reasons. It is an alternate shift of posture from flexion of the back (rounded) to the extension of the back (arched). During each set of movement, inhalation and exhalation will be guided

No Intervention: Control
In control intervention group usual care will be provided.



Primary Outcome Measures :
  1. Pain Score [ Time Frame: 3 Months ]
    It will assessed with the help of Numeric Pain Rating Scale

  2. Extent of Disability [ Time Frame: 3 Months ]
    It will be detected with the help of Oswestry Low Back Pain Disability Questionnaire


Secondary Outcome Measures :
  1. Substance P [ Time Frame: 3 Months ]
    Changes in the levels of Substance P will be observed during the span of the study in test and control groups.

  2. Beta Endorphins [ Time Frame: 3 Months ]
    Changes in the levels of beta endorphins will be observed during the span of the study in test and control groups.

  3. Stress Score [ Time Frame: 3 Months ]
    Physical stress of the participants will be evaluated with Sadaf Stress Scale (SSS) before and after the therapy in both the groups.

  4. Cortisol [ Time Frame: 3 Months ]
    Changes in the levels of Cortisol will be observed during the span of the study in test and control groups.

  5. Quality of Life Score [ Time Frame: 3 Months ]
    This measure will be evaluated from baseline to post intervention with the help of World Health organization Quality of Life (WHOQOL) Questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Answer Yes to the following questions.

  1. Have low back pain constantly or on most days for the last three months.
  2. Have you seek care from health care provider due to back pain
  3. Average pain intensity, assessed using the Numerical Pain Rating (NPR) scale over the past week ≥ 2 on a 0-10 numerical pain scale.
  4. Roland Morris Disability Questionnaire score ≥ 4.
  5. Fear Avoidance Beliefs Questionnaire (FABQ) work subscale score <19.

Exclusion Criteria:

  • To be eligible for the study participants must not:

    • Have a personal history of the following neurological disorders: Alzheimer's, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's, Stroke
    • Have a personal history of the following cardiorespiratory disorders: Congestive heart failure, Heart attack in past 24 months
    • Have a personal history of the following musculoskeletal disorders: Rheumatoid Arthritis, pathologic fractures of the spine, avascular necrosis or osteonecrosis, severe osteoarthritis. Including a history of spine surgery or a hip arthroplasty
    • Have active cancer
    • Be Blind
    • Report being pregnant, lactating, or that they anticipate becoming pregnant in the next 3-months
    • Have a body mass index greater than 35 kg/m2
    • Have clinical depression (i.e., subjects who score 24 or higher on the Center for Epidemiology Depression Scale).
    • Have used narcotics or muscle relaxants within 30 days prior to study enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723225


Contacts
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Contact: Farah Batool, M.Sc 03122497597 farahbatool97@gmail.com
Contact: Sadaf Ahmed, Ph.D. 03333061127 Sadafa@uok.edu.pk

Locations
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Pakistan
Koohi Goth Women Hospital
Karachi, Sindh, Pakistan, 24740
Contact: Stephen Riaz, BSN         
Sponsors and Collaborators
University of Karachi
Publications of Results:

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Responsible Party: Shamoon Noushad, Principal Investigator, University of Karachi
ClinicalTrials.gov Identifier: NCT04723225    
Other Study ID Numbers: PPL-CAT2020
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shamoon Noushad, University of Karachi:
Cat Cow Yoga
Yoga Therapy
Healthcare Providers
Substance P
Chronic low back pain
Cortisol
Beta Endorphins
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations