Chronic Musculoskeletal PainNCT04313309
Evaluating Chronic Pain Management Program
A study testing Integrative Yoga Therapy in people with Chronic Musculoskeletal Pain, run by Aarogyam UK.
Trial summary
This interventional study seeks to evaluate the overall outcomes of a novel, integrated yoga based intervention for people with chronic musculoskeletal pain and assess the experience of patient to the self care using yoga practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- Integrative Yoga Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2020to 30 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with chronic musculoskeletal pain, not accounted for by disease or underlying pathology
- Self referred or referred willing to give informed consent
Who cannot join
- Autoimmune disorder
- Malignancies
- Cognitively impairment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluating Outcomes of a Integrative Yoga Therapy for People With Chronic Pain
This interventional study seeks to evaluate the overall outcomes of a novel, integrated yoga based intervention for people with chronic musculoskeletal pain and assess the experience of patient to the self care using yoga practices.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- Integrative Yoga Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Yoga TherapyOther
Individualised intervention developed, consists of a six one to one sessions with patients, followed by home self practiced sessions. The intervention includes yoga movements, yoga breathing, relaxation techniques, reasoning, and other techniques designed to enhance awareness and acceptance of the psychological factors underlying the chronic pain problem.
| Study group | Role | What they receive |
|---|---|---|
| Support Group | Experimental | This is the only group in the study consisting of patients with chronic musculoskeletal pain who are receiving the Integrative Yoga Therapy Program Receives: Other: Integrative Yoga Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of pain and its impact on functioning: Brief Pain Inventory
Brief Pain Inventory
Measured: From baseline to 6-week post intervention
Secondary outcomes (2)
General Quality of Life: Nottingham Health Profile
Nottingham Health Profile
Measured: From baseline to 6-week post intervention
Pain Service Satisfaction: The Pain Service Satisfaction Test (PSST)
The Pain Service Satisfaction Test (PSST)
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 start15 Apr 2020 (estimated)
- Primary completion15 Jul 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Principal investigator, Aarogyam UKJaydeep Joshi, BAMS, Study chair, Aarogyam UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313309
- Sponsor's protocol ID
- AU021
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2020
- Last updated
- 18 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 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Outcomes of a Integrative Yoga Therapy for People With Chronic Pain
- ClinicalTrials.gov ID
- NCT04313309
- Acronym / sponsor ID
- AU021
- Conditions
- Chronic Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Study start
- 15 Apr 2020 (estimated)
- Primary completion
- 15 Jul 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- 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.
This interventional study seeks to evaluate the overall outcomes of a novel, integrated yoga based intervention for people with chronic musculoskeletal pain and assess the experience of patient to the self care using yoga practices.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Support Group | Experimental | Other: Integrative Yoga TherapyThis is the only group in the study consisting of patients with chronic musculoskeletal pain who are receiving the Integrative Yoga Therapy Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with chronic musculoskeletal pain, not accounted for by disease or underlying pathology
- Self referred or referred willing to give informed consent
Key exclusion criteria (3 listed)
- Autoimmune disorder
- Malignancies
- Cognitively 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 |
|---|---|---|
| Integrative Yoga TherapyIndividualised intervention developed, consists of a six one to one sessions with patients, followed by home self practiced sessions. The intervention includes yoga movements, yoga breathing, relaxation techniques, reasoning, and other techniques designed to enhance awareness and acceptance of the psychological factors underlying the chronic pain problem. | Other | Support Group |
Primary outcome
Severity of pain and its impact on functioning: Brief Pain Inventory
Time frame: From baseline to 6-week post intervention
Brief Pain Inventory
2 secondary outcomes
General Quality of Life: Nottingham Health Profile
Time frame: From baseline to 6-week post intervention
Pain Service Satisfaction: The Pain Service Satisfaction Test (PSST)
Time frame: From baseline to 6-week post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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 chair
Aarogyam UK
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Yoga Therapy in people with Chronic Musculoskeletal Pain, run by Aarogyam UK.
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: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Usha Solanki (+44 7448307225, ukaarogyam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of pain and its impact on functioning: Brief Pain Inventory (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 18 Mar 2020.