HeadacheNCT04313491
Effectiveness of Yoga@Work to Reduce Head and Muscle Pain in Office Workers
A study testing Yoga in people with Headache and Cervical Pain, run by Aarogyam UK at 1 site in United Kingdom.
Trial summary
The primary objective of this study is to evaluate the effectiveness of a workplace yoga intervention in reducing the frequency of pain involving the head and neck area. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache, Cervical Pain, Musculoskeletal Pain
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Feb 2019to 12 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Office workers
- Willing to participate an give consent
Who cannot join
- Secondary headache
- Neck injury
- Trauma
- Critically ill
- Cognitive impairment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Yoga@Work to Reduce Head and Muscle Pain in Office Workers: Quasi Experimental Study
The primary objective of this study is to evaluate the effectiveness of a workplace yoga intervention in reducing the frequency of pain involving the head and neck area.
- Conditions
- Headache, Cervical Pain, Musculoskeletal Pain
- Being tested
- Yoga
- Medical subject headings
- Headache, Neck Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
Relaxation yoga exercises, yoga breathing, yoga sound and imagery practices
| Study group | Role | What they receive |
|---|---|---|
| Yoga@Work | Experimental | Not described Receives: Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of headache, neck and shoulder pain
Pain Journal assessed the number of days with headache, neck and shoulder pain
Measured: From baseline to 6-week post intervention
Secondary outcomes (2)
Severity of head, neck and shoulder pain
Visual Analogue Scale was used to assess the severity of pain with 0 to 10 scale; 0 describe no pain and 10 worst pain.
Measured: From baseline to 6-week post intervention
Analgesics use
Daily pain journal was used to assess analgesics use
Measured: From baseline to 6-week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start16 Feb 2019
- Primary completion30 Jun 2019
- Study completion12 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Collaborators
- Brunel University
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Principal investigator, Aarogyam UKJaydeep Joshi, BAMS, Study director, Aarogyam UKMonomita Nandy, Study chair, Brunel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313491
- Sponsor's protocol ID
- AU04
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 20 Mar 2020
- 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 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Yoga@Work to Reduce Head and Muscle Pain in Office Workers: Quasi Experimental Study
- ClinicalTrials.gov ID
- NCT04313491
- Acronym / sponsor ID
- AU04
- Conditions
- Headache, Cervical Pain, Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Collaborators
- Brunel University
- Study start
- 16 Feb 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 18 Mar 2020 (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.
The primary objective of this study is to evaluate the effectiveness of a workplace yoga intervention in reducing the frequency of pain involving the head and neck area.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga@Work | Experimental | Other: Yoga |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Office workers
- Willing to participate an give consent
Key exclusion criteria (6 listed)
- Secondary headache
- Neck injury
- Trauma
- Critically ill
- Cognitive impairment
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 |
|---|---|---|
| YogaRelaxation yoga exercises, yoga breathing, yoga sound and imagery practices | Other | Yoga@Work |
Primary outcome
Frequency of headache, neck and shoulder pain
Time frame: From baseline to 6-week post intervention
Pain Journal assessed the number of days with headache, neck and shoulder pain
2 secondary outcomes
Severity of head, neck and shoulder pain
Time frame: From baseline to 6-week post intervention
Analgesics use
Time frame: From baseline to 6-week post intervention
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 20 Mar 2020.
- 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
Aarogyam UK
Jaydeep Joshi, BAMS study director
Aarogyam UK
Monomita Nandy study chair
Brunel University
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 Headache and Cervical Pain, run by Aarogyam UK at 1 site in United Kingdom.
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 6 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 20 Mar 2020. 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 United Kingdom. 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?
Frequency of headache, neck and shoulder pain (time frame: From baseline to 6-week post intervention). 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 20 Mar 2020.