Disability Physical, Musculoskeletal Pain, Psychological Distress
Conditions
Brief 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 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.
Interventions
OTHERChiropractic care (one visit)
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
OTHERChiropractic care (more than one visit)
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
Sponsors
Université du Québec à Trois-Rivières
University of Birmingham
Real Centro Universitario Maria Cristina
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Care was provided by chiropractors,
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* chiropractic patients active when lockdown was declared, over the age of 14
Exclusion criteria
* new patients in the clinic, patients with no current pain at the time of the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 14 days | Numerical rating scale (0-10, 0 meaning no pain, 10 meaning worst pain imaginable) |
| Pain frequency | 14 days | Likert Scale from better (1) to worst (4) outcomes, 1: occasionally, 4: constantly |
| Pain evolution | 14 days | Likert Scale of self-perceived improvement, from better (1) to worst (5) outcomes, 1: much better, 5: much worse |
| Pain interference | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophizing Scale | 14 days | Validated questionnaire. Short version 4 items, Likert scale from 0 to 4, lowest score (0) better outcomes, highest score (16) worst outcomes |
| Tampa Scale Kinesiophobia | 14 days | Validated questionnaire. Short version 11 items, Likert scale from 1 to 4, lowest score (11) better outcomes, highest score (44) worst outcomes |
| General Anxiety Disorder scale | 14 days | Validated questionnaire 7 items, Likert scale from 0 to 3, lowest score (0) better outcomes, highest score (21) worst outcomes |
| Intolerance of Uncertainty Scale | 14 days | Validated questionnaire. Short version 12 items, Likert scale from 1 to 5, lowest score (12) better outcomes, highest score (60) worst outcomes |
| General Self-Efficacy scale | 14 days | Validated questionnaire 10 items, Likert scale from 1 to 10, lowest score (10) WORST outcomes, highest score (100) BETTER outcomes |
| Fear of Illness and Virus Evaluation | 14 days | Questionnaire, subscale 10 items, Likert scale from 1 to 4, lowest score (1) WORST outcomes, highest score (40) BETTER outcomes |
Countries
Spain
Outcome results
None listed