Effectiveness of Cat-Cow Yoga in Managing Chronic Low Back Pain
Primary Purpose
Chronic Low-back Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Cat-Cow Yoga
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Low-back Pain focused on measuring Cat Cow Yoga, Yoga Therapy, Healthcare Providers, Substance P, Chronic low back pain, Cortisol, Beta Endorphins
Eligibility Criteria
Inclusion Criteria:
Answer Yes to the following questions.
- Have low back pain constantly or on most days for the last three months.
- Have you seek care from health care provider due to back pain
- Average pain intensity, assessed using the Numerical Pain Rating (NPR) scale over the past week ≥ 2 on a 0-10 numerical pain scale.
- Roland Morris Disability Questionnaire score ≥ 4.
- 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.
Sites / Locations
- Koohi Goth Women Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
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.
In control intervention group usual care will be provided.
Outcomes
Primary Outcome Measures
Pain Score
It will assessed with the help of Numeric Pain Rating Scale. using a 0-10 scale, where 0 corresponds to "no pain" and 10 to "the greatest pain possible."
Extent of Disability
It will be detected with the help of Oswestry Low Back Pain Disability Questionnaire. This index is considered a standard to assess low back functionality, it has a total of 10 sections, and for each section with a possible score 5. The percentage improvement is calculated through the total possible score x 100.
Secondary Outcome Measures
Substance P
Changes in the levels of Substance P will be observed during the span of the study in test and control groups.
Beta Endorphins
Changes in the levels of beta endorphins will be observed during the span of the study in test and control groups.
Stress Score
Physical stress of the participants will be evaluated with Sadaf Stress Scale (SSS) before and after the therapy in both the groups.
Cortisol
Changes in the levels of Cortisol will be observed during the span of the study in test and control groups.
Quality of Life Score
This measure will be evaluated from baseline to post intervention with the help of World Health organization Quality of Life (WHOQOL) Questionnaire
Full Information
NCT ID
NCT04723225
First Posted
January 20, 2021
Last Updated
February 5, 2023
Sponsor
University of Karachi
1. Study Identification
Unique Protocol Identification Number
NCT04723225
Brief Title
Effectiveness of Cat-Cow Yoga in Managing Chronic Low Back Pain
Official Title
To Observe The Effectiveness Of Cat-Cow Yoga In The Pain Management Of Chronic Low Back Pain In Health Care Professionals
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
December 15, 2022 (Actual)
Study Completion Date
January 20, 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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Cat Cow Yoga, Yoga Therapy, Healthcare Providers, Substance P, Chronic low back pain, 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
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
In control intervention group usual care will be provided.
Intervention Type
Other
Intervention Name(s)
Cat-Cow Yoga
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain Score
Description
It will assessed with the help of Numeric Pain Rating Scale. using a 0-10 scale, where 0 corresponds to "no pain" and 10 to "the greatest pain possible."
Time Frame
3 Months
Title
Extent of Disability
Description
It will be detected with the help of Oswestry Low Back Pain Disability Questionnaire. This index is considered a standard to assess low back functionality, it has a total of 10 sections, and for each section with a possible score 5. The percentage improvement is calculated through the total possible score x 100.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Substance P
Description
Changes in the levels of Substance P will be observed during the span of the study in test and control groups.
Time Frame
3 Months
Title
Beta Endorphins
Description
Changes in the levels of beta endorphins will be observed during the span of the study in test and control groups.
Time Frame
3 Months
Title
Stress Score
Description
Physical stress of the participants will be evaluated with Sadaf Stress Scale (SSS) before and after the therapy in both the groups.
Time Frame
3 Months
Title
Cortisol
Description
Changes in the levels of Cortisol will be observed during the span of the study in test and control groups.
Time Frame
3 Months
Title
Quality of Life Score
Description
This measure will be evaluated from baseline to post intervention with the help of World Health organization Quality of Life (WHOQOL) Questionnaire
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:
Answer Yes to the following questions.
Have low back pain constantly or on most days for the last three months.
Have you seek care from health care provider due to back pain
Average pain intensity, assessed using the Numerical Pain Rating (NPR) scale over the past week ≥ 2 on a 0-10 numerical pain scale.
Roland Morris Disability Questionnaire score ≥ 4.
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.
Facility Information:
Facility Name
Koohi Goth Women Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
24740
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Cat-Cow Yoga in Managing Chronic Low Back Pain
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