Movement Performance in Persons With Chronic Back Pain

NCT06891625 | Recruiting

• 1 other identifier: 2024-07604-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Low-back Pain; Back Disorder

Keywords

chiropractic; physical therapy; open-label placebo; motion capture; acute effects; pain-intensity

Outcome Measures

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.

  Immediately after each intervention, the participants perform the lifting task. The results will be compared to the baseline measures.

Secondary Outcomes (7)

• Gait - 1) Temporal gait parameters

  Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.

• Gait - 2) Spatial gait parameters

  Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.

• Gait - 3) Joint angles during gait

  Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.

• m-FTF

  Immediately after each intervention, the participants perform the test of active range of motion. The results will be compared to the baseline measures.

• mm-Schober's test

  Immediately after each intervention, the participants perform the test of active range of motion. The results will be compared to the baseline measures.

Study Arms (3)

Spinal manipulation therapy (SMT)

EXPERIMENTAL

Chiropractic treatment

Other: ET; Other: OLP

Exercise Therapy (ET)

EXPERIMENTAL

Physical therapy treatment

Other: SMT; Other: OLP

Open Placebo (OLP)

PLACEBO COMPARATOR

Open-label treatment

Other: SMT; Other: ET

Interventions

SMT OTHER

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.

Exercise Therapy (ET); Open Placebo (OLP)

ET OTHER

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).

Open Placebo (OLP); Spinal manipulation therapy (SMT)

OLP OTHER

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".

Exercise Therapy (ET); Spinal manipulation therapy (SMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• "red flags"
• persons with specific back problems, rheumatic inflammatory joint- and/or back diseases, fractures, diagnosed hip osteoarthritis, fibromyalgia, or neurological co-morbidity.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Stiftelsen Rönnbäret: collaborator

Study Sites (1)

Karolinska Institutet

Huddinge, 141 83, Sweden

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wilhelmus JA Grooten, associated professor

CONTACT

+46-8-52488861; Wim.Grooten@ki.se

Erika Franzen, prof

CONTACT

Erika.Franzen@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University lecturer

Model Details: All participants receive all treatments: SMT, MET and OLP

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 24, 2025
• Study Start: September 1, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 10 years after publication
• Access Criteria: Researcher or university

Locations

SE (1)