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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
SMT
Other interventionIn 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
Other interventionIn 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
Other interventionIn 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".
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: Spinal manipulation therapy (SMT)Experimental treatment 2 interventions
Group B: Exercise Therapy (ET)Experimental treatment 2 interventions
Group C: Open Placebo (OLP)Placebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Lifting performance
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.
Time frame
Immediately after each intervention, the participants perform the lifting task. The results will be compared to the baseline measures.Secondary outcomes
1
Gait - 1) Temporal gait parameters
The participants are asked to walk straight forward at a self-selected walking speed for about 10 meters. The participants' gait is also studied after the instruction to walk as fast as possible (but not run). Gait will be analyzed with temporal gait parameters, such as total cycle time and time in sub-phases. The unit that will be used is milliseconds (ms) and expressed in % of the whole gait cycle, e.g. % single stance, % double support, etc.
Time frame
Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.2
Gait - 2) Spatial gait parameters
The participants are asked to walk straight forward at a self-selected walking speed for about 10 meters. The participants' gait is also studied after the instruction to walk as fast as possible (but not run). Gait will be analyzed with spatial gait parameters, such as step length and step width, stride length. The SI-unit that will be used is meters (m).
Time frame
Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.3
Gait - 3) Joint angles during gait
The participants are asked to walk straight forward at a self-selected walking speed and after an instruction to walk as fast as possible for about 10 meters (but not to run). The subject will be asked to perform these tasks two consecutive times, and the second trial will be used in the analyses. Spatial angles (unit: degrees) in neck, upper back, lower back, hips, knees and ankle joints will be analyzed during each gait cycle in three planes: sagittal, frontal and transversal plane. These will be printed vs gait-cycle % and compared to normal values (available from the software). Moreover, angle velocity and inter-segmental coordination, i.e. the movement performance of different segments simultaneously is studied by plotting angle-angle diagrams for an analysis of movement quality.
Time frame
Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.4
m-FTF
Modified finger-to-floor test (m-FTF). Participants will be asked to make an attempt to bend forward as far as possible, keeping their knees, arms, and fingers fully extended. The vertical distance between the tip of the third finger and the floor is measured by placing a ruler under the third finger at a 90° angle to the tape measure on the wall; less distance indicates greater active trunk mobility.
Time frame
Immediately after each intervention, the participants perform the test of active range of motion. The results will be compared to the baseline measures.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Stiftelsen Rönnbäret
Collaborator
Source ClinicalTrials.gov