Musculoskeletal PainNCT04573361
Access to Chiropractic Care During the COVID-19 Healthcare Emergency in Spain
A study testing Chiropractic care (one visit) and Chiropractic care (more than one visit) in people with Musculoskeletal Pain and Disability Physical, run by Real Centro Universitario Maria Cristina at 1 site in Spain.
Trial summary
This is a pragmatic controlled clinical trial taking place in the first phase of COVID-19 lockdown re-opening in Spain. Patients of 52 chiropractic clinics were invited to participate in a pseudo-random order (one out of every three contacted patients) as they were contacted to either schedule an appointment with… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Musculoskeletal Pain, Disability Physical, Psychological Distress
- What is being tested?
- Chiropractic care (one visit) and Chiropractic care (more than one visit)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 723 participants
- Where
- 1 siteSpain
- Study dates
- 2 May 2020to 27 May 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- chiropractic patients active when lockdown was declared, over the age of 14
Who cannot join
- new patients in the clinic, patients with no current pain at the time of the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Access to Chiropractic Care During the State of Emergency Generated by the COVID-19 Pandemic in Spain: a Pragmatic Controlled Trial
This is a pragmatic controlled clinical trial taking place in the first phase of COVID-19 lockdown re-opening in Spain. Patients of 52 chiropractic clinics were invited to participate in a pseudo-random order (one out of every three contacted patients) as they were contacted to either schedule an appointment with their current chiropractor or not, depending on the clinic's and the patient's availability. Patients would receive chiropractic in-person care (one or more than one visits) or no care at all, for a two-week period. According to the care received, they were assigned to one of three groups (receiving no care, receiving care once, and more than once). Participants filled an online questionnaire with self-reported outcome-measures at the beginning of the two week period. A follow-up questionnaire was completed 14 days after.
- Being tested
- Chiropractic care (one visit), Chiropractic care (more than one visit)
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic care (one visit)Other
Also called Chiropractic Tx1
One visit to the chiropractor based on the use of spinal manipulative therapy, mobilization and other forms of manual therapy, exercise therapy, patient education, advice and reassurance
Chiropractic care (more than one visit)Other
Also called Chiropractic Tx2
More than one visit to the chiropractor based on the use of spinal manipulative therapy, mobilization and other forms of manual therapy, exercise therapy, patient education, advice and reassurance
| Study group | Role | What they receive |
|---|---|---|
| Group Control | No intervention | Patients having no access to chiropractic treatment during the trial |
| Group Chiropractic Care one session | Experimental | Patients having access to in-person chiropractic treatment once during the trial Receives: Other: Chiropractic care (one visit) |
| Group Chiropractic Care multiple sessions | Experimental | Patients having access to in-person chiropractic treatment more than once during the trial Receives: Other: Chiropractic care (more than one visit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Numerical rating scale (0-10, 0 meaning no pain, 10 meaning worst pain imaginable)
Measured: 14 days
Pain frequency
Likert Scale from better (1) to worst (4) outcomes, 1: occasionally, 4: constantly
Measured: 14 days
Pain evolution
Likert Scale of self-perceived improvement, from better (1) to worst (5) outcomes, 1: much better, 5: much worse
Measured: 14 days
Pain interference
Validated subscale form the Brief Pain Inventory, 6 categories from 0 to 10 each, the lower, the better outcomes, out of a minimal of 0 and total of 60.
Measured: 14 days
Secondary outcomes (6)
Pain Catastrophizing Scale
Validated questionnaire. Short version 4 items, Likert scale from 0 to 4, lowest score (0) better outcomes, highest score (16) worst outcomes
Measured: 14 days
Tampa Scale Kinesiophobia
Validated questionnaire. Short version 11 items, Likert scale from 1 to 4, lowest score (11) better outcomes, highest score (44) worst outcomes
Measured: 14 days
General Anxiety Disorder scale
Validated questionnaire 7 items, Likert scale from 0 to 3, lowest score (0) better outcomes, highest score (21) worst outcomes
Measured: 14 days
Intolerance of Uncertainty Scale
Validated questionnaire. Short version 12 items, Likert scale from 1 to 5, lowest score (12) better outcomes, highest score (60) worst outcomes
Measured: 14 days
General Self-Efficacy scale
Validated questionnaire 10 items, Likert scale from 1 to 10, lowest score (10) WORST outcomes, highest score (100) BETTER outcomes
Measured: 14 days
Fear of Illness and Virus Evaluation
Questionnaire, subscale 10 items, Likert scale from 1 to 4, lowest score (1) WORST outcomes, highest score (40) BETTER outcomes
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start2 May 2020
- Primary completion27 May 2020
- Study completion27 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three arms depending on the access to chiropractic care (no access, one visit or more than one) during the 14-days period of the trial. Measures were taken at the beginning and at the end of the 14-day period.
- Masking
- None (open label)
- Enrolment
- 723 participants (actual)
Sponsor and investigators
- Lead sponsor
- Real Centro Universitario Maria Cristina
- Sponsor type
- University, hospital or other
- Collaborators
- Université du Québec à Trois-Rivières, University of Birmingham
- Responsible party
- Sponsor
- Investigators
- Arantxa Ortega de Mues, PhD, Principal investigator, Madrid College of Chiropractic - Real Centro Universitario Maria Cristina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573361
- Sponsor's protocol ID
- ChiroCOVID19
- Status last verified
- Sep 2020
- First submitted
- 29 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All collected IPD will be shared, though a next phase of the study is being debated, which is why we are still undecided.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access to Chiropractic Care During the State of Emergency Generated by the COVID-19 Pandemic in Spain: a Pragmatic Controlled Trial
- ClinicalTrials.gov ID
- NCT04573361
- Acronym / sponsor ID
- ChiroCOVID19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 723 participants (actual)
- Lead sponsor
- Real Centro Universitario Maria CristinaUniversity, hospital or other
- Collaborators
- Université du Québec à Trois-Rivières, University of Birmingham
- Study start
- 2 May 2020 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 5 Oct 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 is a pragmatic controlled clinical trial taking place in the first phase of COVID-19 lockdown re-opening in Spain. Patients of 52 chiropractic clinics were invited to participate in a pseudo-random order (one out of every three contacted patients) as they were contacted to either schedule an appointment with their current chiropractor or not, depending on the clinic's and the patient's availability. Patients would receive chiropractic in-person care (one or more than one visits) or no care at all, for a two-week period. According to the care received, they were assigned to one of three groups (receiving no care, receiving care once, and more than once). Participants filled an online questionnaire with self-reported outcome-measures at the beginning of the two week period. A follow-up questionnaire was completed 14 days after.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three arms depending on the access to chiropractic care (no access, one visit or more than one) during the 14-days period of the trial. Measures were taken at the beginning and at the end of the 14-day period.
| Arm | Type | Receives |
|---|---|---|
| Group Control | No intervention | –Patients having no access to chiropractic treatment during the trial |
| Group Chiropractic Care one session | Experimental | Other: Chiropractic care (one visit)Patients having access to in-person chiropractic treatment once during the trial |
| Group Chiropractic Care multiple sessions | Experimental | Other: Chiropractic care (more than one visit)Patients having access to in-person chiropractic treatment more than once during the trial |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- chiropractic patients active when lockdown was declared, over the age of 14
Key exclusion criteria (1 listed)
- new patients in the clinic, patients with no current pain at the time of the trial
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 |
|---|---|---|
| Chiropractic care (one visit)Also: Chiropractic Tx1One visit to the chiropractor based on the use of spinal manipulative therapy, mobilization and other forms of manual therapy, exercise therapy, patient education, advice and reassurance | Other | Group Chiropractic Care one session |
| Chiropractic care (more than one visit)Also: Chiropractic Tx2More than one visit to the chiropractor based on the use of spinal manipulative therapy, mobilization and other forms of manual therapy, exercise therapy, patient education, advice and reassurance | Other | Group Chiropractic Care multiple sessions |
Primary outcome
Pain intensity
Time frame: 14 days
Numerical rating scale (0-10, 0 meaning no pain, 10 meaning worst pain imaginable)
Pain frequency
Time frame: 14 days
Likert Scale from better (1) to worst (4) outcomes, 1: occasionally, 4: constantly
Pain evolution
Time frame: 14 days
Likert Scale of self-perceived improvement, from better (1) to worst (5) outcomes, 1: much better, 5: much worse
Pain interference
Time frame: 14 days
Validated subscale form the Brief Pain Inventory, 6 categories from 0 to 10 each, the lower, the better outcomes, out of a minimal of 0 and total of 60.
6 secondary outcomes
Pain Catastrophizing Scale
Time frame: 14 days
Tampa Scale Kinesiophobia
Time frame: 14 days
General Anxiety Disorder scale
Time frame: 14 days
Intolerance of Uncertainty Scale
Time frame: 14 days
General Self-Efficacy scale
Time frame: 14 days
Fear of Illness and Virus Evaluation
Time frame: 14 days
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 5 Oct 2020.
- Individual participant dataSharing planned: Undecided. All collected IPD will be shared, though a next phase of the study is being debated, which is why we are still undecided.
Related trials for Musculoskeletal Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
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.
Arantxa Ortega de Mues, PhD principal investigator
Madrid College of Chiropractic - Real Centro Universitario Maria Cristina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic care (one visit) and Chiropractic care (more than one visit) in people with Musculoskeletal Pain and Disability Physical, run by Real Centro Universitario Maria Cristina at 1 site in Spain.
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 1 inclusion and 1 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 5 Oct 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 Spain. 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?
Pain intensity (time frame: 14 days). The study lists 4 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 5 Oct 2020.