Chronic Non-Specific Neck PainNCT04113460
The Effectiveness Yoga@Work Among Office Workers With Chronic Nonspecific Neck Pain (CNNP)
A study testing Yoga in people with Chronic Non-Specific Neck Pain, run by NMP Medical Research Institute at 1 site in India.
Trial summary
Chronic nonspecific neck pain (CNNP) is a public health issues with a 50% life prevalence. CNNP is a leading cause of disability which contributes to higher costs due to loss of productivity, disability, and increased absenteeism from work. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Non-Specific Neck Pain
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIndia
- Study dates
- 6 Jan 2019to 7 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants who gave written informed consent
- Having neck pain for more than 3 month
Who cannot join
- Systematic disorder
- Neck or spine injuries
- Recent surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness Yoga@Work Among Office Workers With Chronic Nonspecific Neck Pain (CNNP): A Randomised Controlled Trial.
Chronic nonspecific neck pain (CNNP) is a public health issues with a 50% life prevalence. CNNP is a leading cause of disability which contributes to higher costs due to loss of productivity, disability, and increased absenteeism from work. Yoga has been found effective managing neck pain but there has been no study at work setting for chronic non-specific neck pain.
To determine the effectiveness of Yoga@work program for chronic non specific neck pain among office workers, present randomised controlled trial was undertaken.
- Conditions
- Chronic Non-Specific Neck Pain
- Being tested
- Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
Yoga@work program included physical movements, yoga posture, breathing exercise, pranayama and yoga chants. Session with trainer was conducted on worksite once a week for an hour.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Group | Experimental | The yoga group received the 8-week yoga sessions at work setting once a week by trained teacher followed by self practices. Receives: Other: Yoga |
| Control Group | No intervention | Participants had one introductory session on proper physical position and stretching exercises to be practiced daily during work. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Pain
Pain was measured using Visual Analogue Scale
Measured: Change from baseline to 8 weeks
Secondary outcomes (2)
Health related quality of life
HRQoL was measured with the Short Form 36
Measured: Change from baseline to 8 weeks
Neck function
Neck functions with Northwick Park Neck Pain Questionnaire
Measured: change from baseline to 8 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 start6 Jan 2019
- Primary completion15 Jul 2019
- Study completion7 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-Specific Neck PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 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, Study director, Yog-KulamShekhar Sharma, Principal investigator, NMP Medical Research Institute, IndiaJaydeep Joshi, Study chair, Yog-Kulam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113460
- Sponsor's protocol ID
- NMP/32491
- 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
- The Effectiveness Yoga@Work Among Office Workers With Chronic Nonspecific Neck Pain (CNNP): A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT04113460
- Acronym / sponsor ID
- NMP/32491
- Conditions
- Chronic Non-Specific Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Yog-Kulam
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 7 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.
Chronic nonspecific neck pain (CNNP) is a public health issues with a 50% life prevalence. CNNP is a leading cause of disability which contributes to higher costs due to loss of productivity, disability, and increased absenteeism from work. Yoga has been found effective managing neck pain but there has been no study at work setting for chronic non-specific neck pain.
To determine the effectiveness of Yoga@work program for chronic non specific neck pain among office workers, present randomised controlled trial was undertaken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | Experimental | Other: YogaThe yoga group received the 8-week yoga sessions at work setting once a week by trained teacher followed by self practices. |
| Control Group | No intervention | –Participants had one introductory session on proper physical position and stretching exercises to be practiced daily during work. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants who gave written informed consent
- Having neck pain for more than 3 month
Key exclusion criteria (3 listed)
- Systematic disorder
- Neck or spine injuries
- Recent surgery
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 |
|---|---|---|
| YogaYoga@work program included physical movements, yoga posture, breathing exercise, pranayama and yoga chants. Session with trainer was conducted on worksite once a week for an hour. | Other | Yoga Group |
Primary outcome
Neck Pain
Time frame: Change from baseline to 8 weeks
Pain was measured using Visual Analogue Scale
2 secondary outcomes
Health related quality of life
Time frame: Change from baseline to 8 weeks
Neck function
Time frame: change from baseline to 8 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 study director
Yog-Kulam
Shekhar Sharma principal investigator
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 in people with Chronic Non-Specific 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 2 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 8 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.