Chronic Musculoskeletal PainNCT04466605
Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown
A study testing Tele-yoga therapy and Primary care in people with Chronic Musculoskeletal Pain, run by Aarogyam UK at 1 site in India.
Trial summary
Covid-19 outbreak and lockdown measures raised significant concerns over clinical management of chronic pain patients around the world. Patients with chronic musculoskeletal pain (CMSP) are at high risk of physical disability, psychological distress, and poor quality of life. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- Tele-yoga therapy and Primary care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIndia
- Study dates
- 30 Mar 2020to 6 Jul 2020
- 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
- Patients having pain that was musculoskeletal, defined as regional (joints, limbs, back, neck) or more generalized (fibromyalgia or chronic widespread pain);
- Persistent pain ( ≥3 months) despite trying conventional treatment.
- Access to virtual platform with internet.
- Ready to give informed consent
Who cannot join
- Schizophrenia,
- Psychiatric disorder
- Cognitive impairment
- Suicidal ideation
- Current illicit drug use
- Terminal illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown: Randomized Clinical Trial
Covid-19 outbreak and lockdown measures raised significant concerns over clinical management of chronic pain patients around the world. Patients with chronic musculoskeletal pain (CMSP) are at high risk of physical disability, psychological distress, and poor quality of life. Analgesic medications were main management during lockdown, but opioid-related concerns have prompted to find immediate alternatives.
Present study was undertaken to determine whether patients randomized to tele-yoga therapy would experience less pain, disability and improved global health, adherence and satisfaction, compared with patients assigned to usual care.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- Tele-yoga therapy, Primary care
- Keywords
- Tele-Yoga Therapy, Chronic musculoskeletal pain, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-yoga therapyOther
Each session included combinations of different yoga exercises, postures, yoga breathing, yoga relaxation techniques, yoga counselling and meditative practices based on individualisation.
Primary careOther
Patients will follow standard care provided by primary care physicians including analgesics and self care management.
| Study group | Role | What they receive |
|---|---|---|
| Tele-Yoga Therapy | Experimental | All patients randomized to the intervention group had one to one yoga sessions with yoga therapist twice a week for 45 minutes on secure virtual platform. Patients were encouraged with home practice to follow everyday at least for 30-mins. Receives: Other: Tele-yoga therapy |
| Usual Care | Active comparator | Patients randomized to usual care continued to receive care for their chronic musculoskeletal pain from their primary care physician. There was no attempt by to influence clinical management unless an emergency arose Receives: Other: Primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of pain
Pain was assessed using the Brief Pain Inventory (BPI), which rates the severity of pain on 4 items (current, worst, least, and average pain in past week)
Measured: From baseline to 6-week post intervention
Interference of pain
Interference of pain in 7 areas (mood, physical activity, work, social activity, relations with others, sleep, enjoyment of life) were reported using BPI
Measured: From baseline to 6-week post intervention
Secondary outcomes (2)
Global rating of change in pain
7-point global rating of pain change was used to assess change in pain
Measured: From baseline to 6-week post interventiona
Intervention specific satisfaction
10 point scale was used to assess intervention-specific satisfaction
Measured: From baseline to 6-week post interventiona
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start30 Mar 2020
- Primary completion30 Jun 2020
- Study completion6 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Collaborators
- NMP Medical Research Institute, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
- Responsible party
- Sponsor
- Investigators
- Naveen Meghwal, Principal investigator, NMP Medical Research Institute, IndiaNeha Sharma, Study director, Aarogyam UKBhavna Pandya, Study chair, Aarogyam UKAbhimanyu Kumar, Study chair, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466605
- Sponsor's protocol ID
- AU/NMP/0921
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2020
- Last updated
- 10 Jul 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 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04466605
- Acronym / sponsor ID
- AU/NMP/0921
- Conditions
- Chronic Musculoskeletal Pain
- Keywords
- Tele-Yoga Therapy, Chronic musculoskeletal pain, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Collaborators
- NMP Medical Research Institute, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 10 Jul 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.
Covid-19 outbreak and lockdown measures raised significant concerns over clinical management of chronic pain patients around the world. Patients with chronic musculoskeletal pain (CMSP) are at high risk of physical disability, psychological distress, and poor quality of life. Analgesic medications were main management during lockdown, but opioid-related concerns have prompted to find immediate alternatives.
Present study was undertaken to determine whether patients randomized to tele-yoga therapy would experience less pain, disability and improved global health, adherence and satisfaction, compared with patients assigned 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 |
|---|---|---|
| Tele-Yoga Therapy | Experimental | Other: Tele-yoga therapyAll patients randomized to the intervention group had one to one yoga sessions with yoga therapist twice a week for 45 minutes on secure virtual platform. Patients were encouraged with home practice to follow everyday at least for 30-mins. |
| Usual Care | Active comparator | Other: Primary carePatients randomized to usual care continued to receive care for their chronic musculoskeletal pain from their primary care physician. There was no attempt by to influence clinical management unless an emergency arose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients having pain that was musculoskeletal, defined as regional (joints, limbs, back, neck) or more generalized (fibromyalgia or chronic widespread pain);
- Persistent pain ( ≥3 months) despite trying conventional treatment.
- Access to virtual platform with internet.
- Ready to give informed consent
Key exclusion criteria (6 listed)
- Schizophrenia,
- Psychiatric disorder
- Cognitive impairment
- Suicidal ideation
- Current illicit drug use
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 |
|---|---|---|
| Tele-yoga therapyEach session included combinations of different yoga exercises, postures, yoga breathing, yoga relaxation techniques, yoga counselling and meditative practices based on individualisation. | Other | Tele-Yoga Therapy |
| Primary carePatients will follow standard care provided by primary care physicians including analgesics and self care management. | Other | Usual Care |
Primary outcome
Severity of pain
Time frame: From baseline to 6-week post intervention
Pain was assessed using the Brief Pain Inventory (BPI), which rates the severity of pain on 4 items (current, worst, least, and average pain in past week)
Interference of pain
Time frame: From baseline to 6-week post intervention
Interference of pain in 7 areas (mood, physical activity, work, social activity, relations with others, sleep, enjoyment of life) were reported using BPI
2 secondary outcomes
Global rating of change in pain
Time frame: From baseline to 6-week post interventiona
Intervention specific satisfaction
Time frame: From baseline to 6-week post interventiona
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 10 Jul 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.
Naveen Meghwal principal investigator
NMP Medical Research Institute, India
Neha Sharma study director
Aarogyam UK
Bhavna Pandya study chair
Aarogyam UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-yoga therapy and Primary care in people with Chronic Musculoskeletal Pain, run by Aarogyam UK 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 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 10 Jul 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 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?
Severity of pain (time frame: From baseline to 6-week post intervention). The study lists 2 primary outcomes in all. 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 10 Jul 2020.