Cervical SpondylosisNCT03526965
Yoga Chikitsa for Neck Pain Caused by Cervical Spondylosis
A study testing Yoga Chikitsa in people with Cervical Spondylosis, run by NMP Medical Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- Yoga Chikitsa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteIndia
- Study dates
- 15 Apr 2017to 25 Dec 2017
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CS and confirmed by cervical radiographic examination
- Neck pain with CS
- Ready to Consent
Who cannot join
- Pregnancy
- Duration of neck pain < 6 months
- Comorbid systematic condition (Diabetes, Cardiovascular)
- History of cervical surgery, cervical injury, or disease of bones or joints.
Trial locations and contacts
1 site in 1 country.
India1 site
Pain Clinic, NMP Medical Research Institute
Jaipur, Rajasthan, 302019
About this study
Official title: Yoga Chikitsa for Neck Pain Caused by Cervical Spondylosis: a Randomized Controlled Pilot Trial
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.
- Conditions
- Cervical Spondylosis
- Being tested
- Yoga Chikitsa, Usual care
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga ChikitsaOther
Also called Yoga therapy
Intervention consisted of combination of static movements, yoga style exercise, yoga postures, breathing practices, relaxation and yoga counselling.
Usual careDrug
Intervention included pain medications and exercise movements for neck.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Chikitsa | Experimental | YC group were given traditional combination of yoga therapy including loosening movements, physical postures, breathing, relaxation and yoga counselling. Receives: Other: Yoga Chikitsa; Drug: Usual care |
| Usual Care | Active comparator | Usual care were given exercise moves of necks, pain medications prescribed by physicians. Receives: Drug: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Pain
Pain assessed by Northwick Park Neck Pain Questionnaire (NPQ)
Measured: Change from baseline to 6 weeks
Secondary outcomes (1)
Quality of life
Quality of life assessed by SF-36 questionnaire
Measured: Change from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start15 Apr 2017
- Primary completion12 Nov 2017
- Study completion25 Dec 2017
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
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Warwick Research Services
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Study director, Warwick Research ServicesManoj Swami, Principal investigator, NMP Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526965
- Sponsor's protocol ID
- NMP/10124
- Status last verified
- May 2018
- First submitted
- 4 May 2018
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga Chikitsa for Neck Pain Caused by Cervical Spondylosis: a Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT03526965
- Acronym / sponsor ID
- NMP/10124
- Conditions
- Cervical Spondylosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Warwick Research Services
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 12 Nov 2017 (actual)
- Study completion
- 25 Dec 2017 (actual)
- First posted
- 16 May 2018 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Chikitsa | Experimental | Other: Yoga Chikitsa, Drug: Usual careYC group were given traditional combination of yoga therapy including loosening movements, physical postures, breathing, relaxation and yoga counselling. |
| Usual Care | Active comparator | Drug: Usual careUsual care were given exercise moves of necks, pain medications prescribed by physicians. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of CS and confirmed by cervical radiographic examination
- Neck pain with CS
- Ready to Consent
Key exclusion criteria (4 listed)
- Pregnancy
- Duration of neck pain < 6 months
- Comorbid systematic condition (Diabetes, Cardiovascular)
- History of cervical surgery, cervical injury, or disease of bones or joints.
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 ChikitsaAlso: Yoga therapyIntervention consisted of combination of static movements, yoga style exercise, yoga postures, breathing practices, relaxation and yoga counselling. | Other | Yoga Chikitsa |
| Usual careIntervention included pain medications and exercise movements for neck. | Drug | Usual Care, Yoga Chikitsa |
Primary outcome
Neck Pain
Time frame: Change from baseline to 6 weeks
Pain assessed by Northwick Park Neck Pain Questionnaire (NPQ)
1 secondary outcome
Quality of life
Time frame: Change from baseline to 6 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 16 May 2018.
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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 study director
Warwick Research Services
Manoj Swami principal investigator
NMP Medical Research Institute
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 Chikitsa in people with Cervical Spondylosis, 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 3 inclusion and 4 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 16 May 2018. 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 6 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 16 May 2018.