Cervical SpondylosisNCT04113473
An Evaluation of Yoga Therapy for Cervical Spondylosis
A study testing Yoga Therapy in people with Cervical Spondylosis and Neck Pain, run by NMP Medical Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cervical Spondylosis, Neck Pain
- What is being tested?
- Yoga Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIndia
- Study dates
- 11 Dec 2018to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- History of neck trauma, fracture or surgery,
- Systematic disease of the neck or spine including bones and joints conditions,
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cervical Spondylosis, Neck Pain
- Being tested
- Yoga Therapy
- Medical subject headings
- Spondylosis, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Group | Experimental | Experimental group received individualised yoga therapy twice a week for an hour for 12-weeks. Receives: Other: Yoga Therapy |
| Control Group | No intervention | Control group were given education session and continued on usual care for 12-weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain
ain intensity was measured by a 10-cm VAS scale, with 0 = "no Pain" and 10 = "the worst imaginable pain
Measured: Change from baseline to 12 weeks
Secondary outcomes (2)
Disability
Neck disability was measured using neck disability index (NDI) score
Measured: Change from baseline to 12 weeks
Health related Quality of Life
Short Form-36 assessed the Quality of life
Measured: change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start11 Dec 2018
- Primary completion12 Jul 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Yog-Kulam
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Principal investigator, Yog-KulamShekhar Sharma, Study director, NMP Medical Research Institute, IndiaJaydeep Joshi, Study chair, Yog-Kulam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113473
- Sponsor's protocol ID
- NMP/62548
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Yoga Therapy for Neck Pain Relief in Patients With Cervical Spondylosis
- ClinicalTrials.gov ID
- NCT04113473
- Acronym / sponsor ID
- NMP/62548
- Conditions
- Cervical Spondylosis, Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Yog-Kulam
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | Experimental | Other: Yoga TherapyExperimental group received individualised yoga therapy twice a week for an hour for 12-weeks. |
| Control Group | No intervention | –Control group were given education session and continued on usual care for 12-weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- History of neck trauma, fracture or surgery,
- Systematic disease of the neck or spine including bones and joints conditions,
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga TherapyAn 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. | Other | Yoga Group |
Primary outcome
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
2 secondary outcomes
Disability
Time frame: Change from baseline to 12 weeks
Health related Quality of Life
Time frame: change from baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Sharma, PhD principal investigator
Yog-Kulam
Shekhar Sharma study director
NMP Medical Research Institute, India
Jaydeep Joshi study chair
Yog-Kulam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Therapy in people with Cervical Spondylosis and Neck Pain, run by NMP Medical Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck pain (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.