Movement Performance in Persons With Chronic Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
The goal of this laboratory-based cross-over randomized controlled study is to study the immediate effects Spinal manipulative therapy (SMT) and exercise therapy (ET) compared to open-label placebo (OLP) on movement performance, gait, active trunk mobility and pain-intensity in persons with chronic non-specific back pain.
The main question this study aims to answer is: What are the immediate and measurable effects of SMT and ET on work movements, gait, active trunk mobility and pain-intensity in people with chronic non-specific back pain, compared with and in combination with open-label placebo treatment (OP)?
The investigators hypothesize that the participants, after SMT and ET, will perform the lifting task faster, and use more range of motion in most of the joints. They also believe that a greater range of motion is used during gait and that the active ROM in the back is increased, while the pain intensity scores decrease after these interventions. The investigators hypothesize that the control intervention (OLP) could be effective as an add-on intervention, but not as a single intervention.
All participants will receive all three interventions SMT, ET and OLP and to study the immediate effects, the participants will be asked:
* to lift a box with two different weights * to walk straight forward with and without a cognitive dual task * perform two clinical tests of active range of motion ( * rate the intensity of their pain "right now" * rank the treatment effects of these three treatment methods
Eligibility criteria
Qualifiers
Persons who have either experienced continuous or recurring back pain for a period longer than 3 months). Back pain is defined as problems/discomfort from the spine Th1-S1 with associated costovertebral joints and sacroiliac joints, thus including both the lumbar spine and the thoracic spine. The area of pain extends from Th1 to the inferior gluteal fold but does not include the shoulder blades
>18 years old,
those who can speak and understand Scandinavian or English.
Disqualifiers
"red flags"
persons with specific back problems, rheumatic inflammatory joint- and/or back diseases, fractures, diagnosed hip osteoarthritis, fibromyalgia, or neurological co-morbidity.
Trial design
Treatments tested in this trial
- SMT
- ET
- OLP
Treatment groups
40 Participants
are divided into 3 treatment groupsSponsors and collaborators
Karolinska Institutet
Lead sponsor
Stiftelsen Rönnbäret
Collaborator
Source ClinicalTrials.gov