Movement Performance in Persons With Chronic Back Pain
Condition(s) studied
Investigational drug(s) / intervention(s)
SMT: In the present study, a short examination of the whole spine and pelvic area will be performed to identify those segments with the highest restricted range of motion compared to other parts. A standard HVLA manipulation of this area is applied, which refers to Maitland grade 5.
ET: In the present study, the participant will, after short warming up, perform three standard exercises aiming to increase the possibility for a person with back pain to control the full range of spinal, pelvis and hip joints (Exercise 1) to increase the motor control and coordination of the muscles controlling the low back, pelvis and hip joints in flexion and rotation (Exercise 2), and to increase the motor control of muscles controlling the low back, pelvis and hip joints in extension (Exercise 3).
OLP: In the present study, the procedure will follow the study of Carvalho, et al. (2016).28 The researcher explains clearly in a positive way to the participants that i) a placebo effect can be powerful, ii) the body can automatically respond to taking placebo pills like Pavlov's dogs that salivated when they heard a clock, iii) that a positive attitude can be helpful, but is not necessary, and iiii) the researcher shows a short video clip (1 minute 25 seconds) of a news report, where participants in an OLP study are interviewed on the positive effects they experienced (https://www.youtube.com/watch?v=Jp14Lhl0T9). Thereafter, the participants are asked to take two pills, containing the inactive substance microcrystalline cellulose from a container clearly labeled with "placebo".
Study summary
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
Primary outcome measure(s)
- Lifting performance — Immediately after each intervention, the participants perform the lifting task. The results will be compared to the baseline measures.
Participants are asked to perform the movement at a comfortable self-selected speed. They perform two consecutive lifts and between the lifts, the test staff will the object to its original position. To standardize the test, the height of the table is adjusted to 50% of the participant's body height and the horizontal distance between the participant and the table to 75% of his/her arm length. The lift is performed in two situations: one "light" situation and one "moderate/heavy" situation. Kinematic and kinetic variables defining movement performance during the lifting task will be used to analyze the data. The lifts will be divided into two phases: a downward and an upward phase, and expressed in % movement-time. For each phase, we will study variables such as fixed time, speed of movement, ROM, intersegmental coordination.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Karolinska Institutet | Huddinge | Sweden | Recruiting |
More Karolinska Institutet trials in Sweden
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06891625 on ClinicalTrials.gov ↗ ← All trials in Sweden