Movement Performance in Persons With Chronic Back Pain

NCT06891625 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-14

No results posted yet for this 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

Conditions

  • Chronic Low-back Pain
  • Back Disorder

Interventions

OTHER

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.

OTHER

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).

OTHER

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".

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2025-12-30
Completion
2026-09-30

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06891625 on ClinicalTrials.gov