An Evaluation of Yoga Therapy for Cervical Spondylosis

NCT04113473 | Completed DMC

• 1 other identifier: NMP/62548
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spondylosis; Neck Pain

Outcome Measures

Primary Outcomes (1)

• Neck pain

  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 Outcomes (2)

• Disability

  Change from baseline to 12 weeks

• Health related Quality of Life

  change from baseline to 12 weeks

Study Arms (2)

Yoga Group

EXPERIMENTAL

Experimental group received individualised yoga therapy twice a week for an hour for 12-weeks.

Other: Yoga Therapy

Control Group

NO INTERVENTION

Control group were given education session and continued on usual care for 12-weeks.

Interventions

Yoga Therapy OTHER

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.

Yoga Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• History of neck trauma, fracture or surgery,
• Systematic disease of the neck or spine including bones and joints conditions,
• Pregnancy

Sponsors & Collaborators

• NMP Medical Research Institute: lead
• Yog-Kulam: collaborator

Study Sites (1)

Pain Clinic, NMP Medical Research Institute

Jaipur, Rajasthan, India

Location

MeSH Terms

Conditions

Spondylosis; Neck Pain

Interventions

Yoga

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Neha Sharma, PhD

  Yog-Kulam

  PRINCIPAL INVESTIGATOR

• Shekhar Sharma

  NMP Medical Research Institute, India

  STUDY DIRECTOR

• Jaydeep Joshi

  Yog-Kulam

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 2, 2019
• Study Start: December 11, 2018
• Primary Completion: July 12, 2019
• Study Completion: August 30, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-10

Locations

IN (1)