Back to resultsYoga Chikitsa for Neck Pain Caused by Cervical Spondylosis
Primary Purpose
Cervical Spondylosis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Yoga Chikitsa
Usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Cervical Spondylosis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of CS and confirmed by cervical radiographic examination
- Neck pain with CS
- Ready to Consent
Exclusion Criteria:
- Pregnancy
- Duration of neck pain < 6 months
- Comorbid systematic condition (Diabetes, Cardiovascular)
- History of cervical surgery, cervical injury, or disease of bones or joints.
Sites / Locations
- Pain Clinic, NMP Medical Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Yoga Chikitsa
Usual Care
Arm Description
YC group were given traditional combination of yoga therapy including loosening movements, physical postures, breathing, relaxation and yoga counselling.
Usual care were given exercise moves of necks, pain medications prescribed by physicians.
Outcomes
Primary Outcome Measures
Neck Pain
Pain assessed by Northwick Park Neck Pain Questionnaire (NPQ)
Secondary Outcome Measures
Quality of life
Quality of life assessed by SF-36 questionnaire
Full Information
NCT ID
NCT03526965
First Posted
May 4, 2018
Last Updated
May 4, 2018
Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services
1. Study Identification
Unique Protocol Identification Number
NCT03526965
Brief Title
Yoga Chikitsa for Neck Pain Caused by Cervical Spondylosis
Official Title
Yoga Chikitsa for Neck Pain Caused by Cervical Spondylosis: a Randomized Controlled Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
November 12, 2017 (Actual)
Study Completion Date
December 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services
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
Neck Pain caused by Cervical spondylosis (CS) is one of the most common health complaints. Despite its frequency as clinical problem worldwide, there are few evidence-based studies that document efficacy of therapies for neck pain. The aim of this study was to evaluate the effects of Yoga chikitsa (Yoga therapy) on pain and quality of life (QOL) in CS patients compared to usual care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spondylosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga Chikitsa
Arm Type
Experimental
Arm Description
YC group were given traditional combination of yoga therapy including loosening movements, physical postures, breathing, relaxation and yoga counselling.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual care were given exercise moves of necks, pain medications prescribed by physicians.
Intervention Type
Other
Intervention Name(s)
Yoga Chikitsa
Other Intervention Name(s)
Yoga therapy
Intervention Description
Intervention consisted of combination of static movements, yoga style exercise, yoga postures, breathing practices, relaxation and yoga counselling.
Intervention Type
Drug
Intervention Name(s)
Usual care
Intervention Description
Intervention included pain medications and exercise movements for neck.
Primary Outcome Measure Information:
Title
Neck Pain
Description
Pain assessed by Northwick Park Neck Pain Questionnaire (NPQ)
Time Frame
Change from baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Quality of life
Description
Quality of life assessed by SF-36 questionnaire
Time Frame
Change from baseline to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of CS and confirmed by cervical radiographic examination
Neck pain with CS
Ready to Consent
Exclusion Criteria:
Pregnancy
Duration of neck pain < 6 months
Comorbid systematic condition (Diabetes, Cardiovascular)
History of cervical surgery, cervical injury, or disease of bones or joints.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Sharma, PhD
Organizational Affiliation
Warwick Research Services
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Manoj Swami
Organizational Affiliation
NMP Medical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Clinic, NMP Medical Research Institute
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302019
Country
India
12. IPD Sharing Statement
Learn more about this trial
Yoga Chikitsa for Neck Pain Caused by Cervical Spondylosis
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