- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04113473
An Evaluation of Yoga Therapy for Cervical Spondylosis
October 1, 2019 updated by: NMP Medical Research Institute
Effectiveness of Yoga Therapy for Neck Pain Relief in Patients With Cervical Spondylosis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rajasthan
-
Jaipur, Rajasthan, India
- Pain Clinic, NMP Medical Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Yoga Group
Experimental group received individualised yoga therapy twice a week for an hour for 12-weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from baseline to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disability
Time Frame: Change from baseline to 12 weeks
|
Neck disability was measured using neck disability index (NDI) score
|
Change from baseline to 12 weeks
|
Health related Quality of Life
Time Frame: change from baseline to 12 weeks
|
Short Form-36 assessed the Quality of life
|
change from baseline to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Shekhar Sharma, NMP Medical Research Institute, India
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 11, 2018
Primary Completion (ACTUAL)
July 12, 2019
Study Completion (ACTUAL)
August 30, 2019
Study Registration Dates
First Submitted
October 1, 2019
First Submitted That Met QC Criteria
October 1, 2019
First Posted (ACTUAL)
October 2, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 2, 2019
Last Update Submitted That Met QC Criteria
October 1, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMP/62548
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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