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Chronic Low-back PainNCT04723225

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

A study testing Cat-Cow Yoga in people with Chronic Low-back Pain, run by University of Karachi at 1 site 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

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. 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?
Cat-Cow Yoga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 sitePakistan
Study dates
30 Jan 2021to 20 Jan 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

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Koohi Goth Women Hospital

    Karachi, Sindh, 24740

Other trials in Pakistan

About this study

Official title: To Observe The Effectiveness Of Cat-Cow Yoga In The Pain Management Of Chronic Low Back Pain In Health Care Professionals

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.

Read the 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.

Being tested
Cat-Cow Yoga
Keywords
Cat Cow Yoga, Yoga Therapy, Healthcare Providers, Substance P, Chronic low back pain, Cortisol, Beta Endorphins

What participants receive

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

  • Cat-Cow YogaOther

    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

Study groups in NCT04723225
Study groupRoleWhat they receive
ExperimentalExperimentalCat-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.
Receives: Other: Cat-Cow Yoga
ControlNo interventionIn control intervention group usual care will be provided.

What is being measured

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

  1. 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."

    Measured: 3 Months

  2. 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.

    Measured: 3 Months

Secondary outcomes (5)

  1. Substance P

    Changes in the levels of Substance P will be observed during the span of the study in test and control groups.

    Measured: 3 Months

  2. Beta Endorphins

    Changes in the levels of beta endorphins will be observed during the span of the study in test and control groups.

    Measured: 3 Months

  3. Stress Score

    Physical stress of the participants will be evaluated with Sadaf Stress Scale (SSS) before and after the therapy in both the groups.

    Measured: 3 Months

  4. Cortisol

    Changes in the levels of Cortisol will be observed during the span of the study in test and control groups.

    Measured: 3 Months

  5. 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

    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 posted25 Jan 2021
  2. Study start30 Jan 2021
  3. Primary completion15 Dec 2022
  4. Study completion20 Jan 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
NCT04723225
Sponsor's protocol ID
PPL-CAT2020
Status last verified
Feb 2023
First submitted
20 Jan 2021
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35191173

  • 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.

    PubMed 34548863

  • Holtzman S, Beggs RT. Yoga for chronic low back pain: a meta-analysis of randomized controlled trials. Pain Res Manag. 2013 Sep-Oct;18(5):267-72. doi: 10.1155/2013/105919. Epub 2013 Jul 26.

    PubMed 23894731

  • Cramer H, Lauche R, Haller H, Dobos G. A systematic review and meta-analysis of yoga for low back pain. Clin J Pain. 2013 May;29(5):450-60. doi: 10.1097/AJP.0b013e31825e1492.

    PubMed 23246998

  • Goode AP, Coeytaux RR, McDuffie J, Duan-Porter W, Sharma P, Mennella H, Nagi A, Williams JW Jr. An evidence map of yoga for low back pain. Complement Ther Med. 2016 Apr;25:170-7. doi: 10.1016/j.ctim.2016.02.016. Epub 2016 Mar 3.

    PubMed 27062965

  • Zhu F, Zhang M, Wang D, Hong Q, Zeng C, Chen W. Yoga compared to non-exercise or physical therapy exercise on pain, disability, and quality of life for patients with chronic low back pain: A systematic review and meta-analysis of randomized controlled trials. PLoS One. 2020 Sep 1;15(9):e0238544. doi: 10.1371/journal.pone.0238544. eCollection 2020.

    PubMed 32870936

  • Alleva J, Hudgins T, Belous J, Kristin Origenes A. Chronic low back pain. Dis Mon. 2016 Sep;62(9):330-3. doi: 10.1016/j.disamonth.2016.05.012. Epub 2016 Jun 22. No abstract available.

    PubMed 27344193

  • Sanzarello I, Merlini L, Rosa MA, Perrone M, Frugiuele J, Borghi R, Faldini C. Central sensitization in chronic low back pain: A narrative review. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):625-633. doi: 10.3233/BMR-160685.

    PubMed 27062464

  • Patrick N, Emanski E, Knaub MA. Acute and chronic low back pain. Med Clin North Am. 2014 Jul;98(4):777-89, xii. doi: 10.1016/j.mcna.2014.03.005.

    PubMed 24994051

  • 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.

    PubMed 30284083

  • 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.

    PubMed 30116793

  • 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.

    PubMed 26444559

  • Veening JG, Barendregt HP. The effects of beta-endorphin: state change modification. Fluids Barriers CNS. 2015 Jan 29;12:3. doi: 10.1186/2045-8118-12-3.

    PubMed 25879522

Questions about this trial

What is this clinical trial studying?

A study testing Cat-Cow Yoga in people with Chronic Low-back Pain, run by University of Karachi at 1 site 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 6 inclusion and 10 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 1 site 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?

Pain Score (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 NCT04723225, which also lists 13 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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