NCT04723225

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

January 30, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.9 years

First QC Date

January 20, 2021

Last Update Submit

February 5, 2023

Conditions

Keywords

Cat Cow YogaYoga TherapyHealthcare ProvidersSubstance PChronic low back painCortisolBeta Endorphins

Outcome Measures

Primary Outcomes (2)

  • 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."

    3 Months

  • 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.

    3 Months

Secondary Outcomes (5)

  • Substance P

    3 Months

  • Beta Endorphins

    3 Months

  • Stress Score

    3 Months

  • Cortisol

    3 Months

  • Quality of Life Score

    3 Months

Study Arms (2)

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

Control

NO INTERVENTION

In control intervention group usual care will be provided.

Interventions

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

Experimental

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koohi Goth Women Hospital

Karachi, Sindh, 24740, Pakistan

Location

Related Publications (13)

  • 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.

    PMID: 35191173BACKGROUND
  • 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.

    PMID: 34548863BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 25, 2021

Study Start

January 30, 2021

Primary Completion

December 15, 2022

Study Completion

January 20, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations