NCT03526965

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

May 4, 2018

Last Update Submit

May 4, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Neck Pain

    Pain assessed by Northwick Park Neck Pain Questionnaire (NPQ)

    Change from baseline to 6 weeks

Secondary Outcomes (1)

  • Quality of life

    Change from baseline to 6 weeks

Study Arms (2)

Yoga Chikitsa

EXPERIMENTAL

YC group were given traditional combination of yoga therapy including loosening movements, physical postures, breathing, relaxation and yoga counselling.

Other: Yoga ChikitsaDrug: Usual care

Usual Care

ACTIVE COMPARATOR

Usual care were given exercise moves of necks, pain medications prescribed by physicians.

Drug: Usual care

Interventions

Intervention consisted of combination of static movements, yoga style exercise, yoga postures, breathing practices, relaxation and yoga counselling.

Also known as: Yoga therapy
Yoga Chikitsa

Intervention included pain medications and exercise movements for neck.

Usual CareYoga Chikitsa

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of CS and confirmed by cervical radiographic examination
  • Neck pain with CS
  • Ready to Consent

You may not qualify if:

  • Pregnancy
  • Duration of neck pain \< 6 months
  • Comorbid systematic condition (Diabetes, Cardiovascular)
  • History of cervical surgery, cervical injury, or disease of bones or joints.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Clinic, NMP Medical Research Institute

Jaipur, Rajasthan, 302019, India

Location

MeSH Terms

Conditions

Spondylosis

Interventions

Yoga

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Neha Sharma, PhD

    Warwick Research Services

    STUDY DIRECTOR
  • Manoj Swami

    NMP Medical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 16, 2018

Study Start

April 15, 2017

Primary Completion

November 12, 2017

Study Completion

December 25, 2017

Last Updated

May 16, 2018

Record last verified: 2018-05

Locations