Movement Performance in Persons With Chronic Back Pain

NCT ID: NCT06891625

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-09-30

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

Detailed Description

The occurrence of chronic non-specific back pain (CBP) is costly for Western society and most persons with CBP are functionally limited in their everyday movements. Studies show positive subjective short-term effects after a period of both spinal manipulative therapy (SMT) and exercise therapy (ET), but the immediate effects on of one session SMT/ET on movement performance are unknown. Open placebo is a relatively new field of research and a promising form of treatment for people with nonspecific pain conditions.

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.

Participants with long-term back pain will be recruited through primary care, such as health centers, private clinics and occupational health services.

All participants will receive all three interventions (around 5-8 minutes each)

• SMT: a doctor of chiropractic will perform HVLA spinal manipulation of areas with restricted range of motion.The areas of interest can be from the neck to the pelvis and hips.
• ET: The participants will be asked to perform mobility and motor control exercises of the trunk and pelvic muscles under supervision.
• OLP: The participant takes two pieces of orange gelatin capsules filled with the inactive substance microcrystalline cellulose, following the procedure described in Carvalho et al (2016). In short, participants will be informed that the pills are placebos and will be shown a news report featuring patients with non-specific complaints, such as migraines and irritable bowel syndrome, who describe their positive experiences with placebo.

Movement performance will be studied in an advanced movement analyses laboratory (Qualisys) and operationalized using kinematic parameters such as movement time, relative phase time, range of motion in the spine and adjacent joints, inter-segmental coordination, etc.

To study the immediate effects on movement performance, the participants will be asked to perform the following functional movements before and immediately after each intervention:

• lifting a box with two different weights from just above ground level and place it on a table in front of them
• walking straight forward at a self-selected walking speed with and without a cognitive dual task
• two clinical tests of active range of motion (modified finger-to-floor test, and the modified m-Schober's test)

Moreover, the participants are asked to:

• rate the intensity of their pain "right now" on an 11-point standard numerical rating scale (NRS)

At the end of the experiment, when all interventions have been applied, the participants are asked to:

• rank the treatment effects of these three treatment methods based on their effectiveness, willingness and preference

Conditions

Chronic Low-back Pain; Back Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spinal manipulation therapy (SMT)

Chiropractic treatment

Group Type: EXPERIMENTAL

ET

Intervention Type: 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).

OLP

Intervention Type: 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)

Physical therapy treatment

Group Type: EXPERIMENTAL

SMT

Intervention Type: 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.

OLP

Intervention Type: 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".

Open Placebo (OLP)

Open-label treatment

Group Type: PLACEBO_COMPARATOR

SMT

Intervention Type: 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.

ET

Intervention Type: 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).

Interventions

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.

Intervention Type: 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).

Intervention Type: 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".

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stiftelsen Rönnbäret

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Wilhelmus Grooten

University lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Karolinska Institutet

Huddinge, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Wilhelmus JA Grooten, associated professor

Role: CONTACT

Wim.Grooten@ki.se

+46-8-52488861

Erika Franzen, prof

Role: CONTACT

Erika.Franzen@ki.se

Facility Contacts

Wilhelmus JA Grooten, Associated professor

Role: primary

Wim.Grooten@ki.se

+46-8-52488861

Other Identifiers

2024-07604-01

Identifier Type: -

Identifier Source: org_study_id