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

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.

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

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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