Back to resultsAn Evaluation of Yoga Therapy for Cervical Spondylosis
Primary Purpose
Cervical Spondylosis, Neck Pain
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Yoga Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Cervical Spondylosis
Eligibility 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
Sites / Locations
- Pain Clinic, NMP Medical Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Yoga Group
Control Group
Arm Description
Experimental group received individualised yoga therapy twice a week for an hour for 12-weeks.
Control group were given education session and continued on usual care for 12-weeks.
Outcomes
Primary Outcome Measures
Neck pain
ain intensity was measured by a 10-cm VAS scale, with 0 = "no Pain" and 10 = "the worst imaginable pain
Secondary Outcome Measures
Disability
Neck disability was measured using neck disability index (NDI) score
Health related Quality of Life
Short Form-36 assessed the Quality of life
Full Information
NCT ID
NCT04113473
First Posted
October 1, 2019
Last Updated
October 1, 2019
Sponsor
NMP Medical Research Institute
Collaborators
Yog-Kulam
1. Study Identification
Unique Protocol Identification Number
NCT04113473
Brief Title
An Evaluation of Yoga Therapy for Cervical Spondylosis
Official Title
Effectiveness of Yoga Therapy for Neck Pain Relief in Patients With Cervical Spondylosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 11, 2018 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NMP Medical Research Institute
Collaborators
Yog-Kulam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spondylosis, Neck Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga Group
Arm Type
Experimental
Arm Description
Experimental group received individualised yoga therapy twice a week for an hour for 12-weeks.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group were given education session and continued on usual care for 12-weeks.
Intervention Type
Other
Intervention Name(s)
Yoga Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neck pain
Description
ain intensity was measured by a 10-cm VAS scale, with 0 = "no Pain" and 10 = "the worst imaginable pain
Time Frame
Change from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Disability
Description
Neck disability was measured using neck disability index (NDI) score
Time Frame
Change from baseline to 12 weeks
Title
Health related Quality of Life
Description
Short Form-36 assessed the Quality of life
Time Frame
change from baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Sharma, PhD
Organizational Affiliation
Yog-Kulam
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shekhar Sharma
Organizational Affiliation
NMP Medical Research Institute, India
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jaydeep Joshi
Organizational Affiliation
Yog-Kulam
Official's Role
Study Chair
Facility Information:
Facility Name
Pain Clinic, NMP Medical Research Institute
City
Jaipur
State/Province
Rajasthan
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
An Evaluation of Yoga Therapy for Cervical Spondylosis
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