Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Evaluation of Yoga Therapy for Cervical Spondylosis

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: NCT04113473
Recruitment Status : Completed
First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
Yog-Kulam
Information provided by (Responsible Party):
NMP Medical Research Institute

Brief Summary:
Cervical spondylosis is a chronic degenerative condition, commonly affecting >40-year-old adults worldwide. Cervical spondylosis is an important cause of neck pain and low back pain, and seriously affects the physical health, mental health, patients quality of life. Yoga has been most commonly used intervention for pain conditions. But its efficacy in cervical spondylosis has not yet been studied in clinical trials. The primary aim of the present study was to assess the efficacy of yoga chikitsa (therapy) compared with control intervention for neck pain caused by cervical spondylosis.

Condition or disease Intervention/treatment Phase
Cervical Spondylosis Neck Pain Other: Yoga Therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Yoga Therapy for Neck Pain Relief in Patients With Cervical Spondylosis
Actual Study Start Date : December 11, 2018
Actual Primary Completion Date : July 12, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Yoga Group
Experimental group received individualised yoga therapy twice a week for an hour for 12-weeks.
Other: Yoga Therapy

An hour of yoga therapy included loosening exercise (sukshma vyayama), yoga postures (asana), yoga breathing (pranayama), relaxation (shavasana) and meditation.

Each participant were given handouts to follow home practice sessions everyday for twice a day for at least 15 minutes.


No Intervention: Control Group
Control group were given education session and continued on usual care for 12-weeks.



Primary Outcome Measures :
  1. Neck pain [ Time Frame: Change from baseline to 12 weeks ]
    ain intensity was measured by a 10-cm VAS scale, with 0 = "no Pain" and 10 = "the worst imaginable pain


Secondary Outcome Measures :
  1. Disability [ Time Frame: Change from baseline to 12 weeks ]
    Neck disability was measured using neck disability index (NDI) score

  2. Health related Quality of Life [ Time Frame: change from baseline to 12 weeks ]
    Short Form-36 assessed the Quality of life



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neck pain of CS as per diagnostic criteria of International Classification of Diseases
  • CS supported by a physical examination, and cervical radiographic examination
  • History of neck pain longer than 3 months
  • willing to provide informed consent

Exclusion Criteria:

  • History of neck trauma, fracture or surgery,
  • Systematic disease of the neck or spine including bones and joints conditions,
  • Pregnancy

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): NCT04113473


Locations
Layout table for location information
India
Pain Clinic, NMP Medical Research Institute
Jaipur, Rajasthan, India
Sponsors and Collaborators
NMP Medical Research Institute
Yog-Kulam
Investigators
Layout table for investigator information
Principal Investigator: Neha Sharma, PhD Yog-Kulam
Study Director: Shekhar Sharma NMP Medical Research Institute, India
Study Chair: Jaydeep Joshi Yog-Kulam
Layout table for additonal information
Responsible Party: NMP Medical Research Institute
ClinicalTrials.gov Identifier: NCT04113473    
Other Study ID Numbers: NMP/62548
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylosis
Neck Pain
Pain
Neurologic Manifestations
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases