Chronic Low-back PainNCT06891625
Movement Performance in Persons With Chronic Back Pain
A study testing SMT, ET and OLP in people with Chronic Low-back Pain and Back Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain, Back Disorder
- What is being tested?
- SMT, ET and OLP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- "red flags"
- persons with specific back problems, rheumatic inflammatory joint- and/or back diseases, fractures, diagnosed hip osteoarthritis, fibromyalgia, or neurological co-morbidity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Erika Franzen, prof contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Huddinge, 141 83
Wilhelmus JA Grooten, Associated professor, +46-8-52488861, Wim.Grooten@ki.se
Wilhelmus JA Grooten, associated professor
About this study
Official title: Acute Effects of Spinal Manipulative Therapy, Exercise Therapy and Open-label Placebo on Movement Performance in Individuals With Chronic Back Pain
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)?
Read more
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
Read the 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
- Being tested
- SMT, ET, OLP
- Keywords
- chiropractic, physical therapy, open-label placebo, motion capture, acute effects, pain-intensity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMTOther
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.
ETOther
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).
OLPOther
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 group | Role | What they receive |
|---|---|---|
| Spinal manipulation therapy (SMT) | Experimental | Chiropractic treatment Receives: Other: ET; Other: OLP |
| Exercise Therapy (ET) | Experimental | Physical therapy treatment Receives: Other: SMT; Other: OLP |
| Open Placebo (OLP) | Placebo comparator | Open-label treatment Receives: Other: SMT; Other: ET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.
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).
Measured: 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
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.
Measured: Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.
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.
Measured: 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
The modified modified-Schober's test (mm-Schober). Participants will be asked to stand in a neutral position. The examiner will place the thumbs on the subject's spina iliaca posterior superior (SIPS) and a line (lower landmark) is drawn along the midline of the lumbar spine horizontally to the SIPS.While the examiner holds the tape firmly against the subject's skin, he/she marks a second line 15 cm above the first line (upper landmark). Then the subject is asked to make an active forward bend of the trunk without increased pain. The difference between the lines is then measured, and rounded to the nearest mm. The test is positive if the difference between the neutral and flexed position in mm-Schober is less than 5 cm.
Measured: Immediately after each intervention, the participants perform the test of active range of motion. The results will be compared to the baseline measures.
Pain-Intensity
Participants are asked to rate the intensity of their pain "right now" on an 11-point standard numerical rating scale (NRS). They are asked to select one number by filling in a questionnaire, or verbally answering a spoken question such as 'Please tell me which of the numbers from 0 to 10 best describes your pain now'. The scale consists of a horizontal with the words 'no pain' and 'worst possible pain' at either end and lines between the numbers '0' and '10' and includes evenly spaced vertical bars numbered '1' to '9'.
Measured: Immediately after each intervention, the participants rate their pain-intensity ("pain right now"). The results will be compared to the baseline measures.
Preference
A final subjective evaluation of the three interventions will be performed by asking the participants to rank the treatment effects of these three treatment methods based on their effectiveness, willingness and preference. Effectiveness will be rated on an 11-point scale (0: not effective/harmful, 10: very effective). Similarly, willingness to use the intervention will be rated starting at " not at all" (0) ranging to "always" (10), and preference will be rated by asking the participants to order the treatments from "best" (1) to "worst" (3). For this three ranking rules are needed: 1) The participants must assign a unique rank to each treatment. 2) There must be one treatment rated as the best (rank 1), one as second best (rank 2), and one as the worst (rank 3). 3) Participants cannot give the same rank to more than one treatment; each treatment has a distinct rank.
Measured: Immediately after all interventions, the participants evaluate the interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants receive all treatments: SMT, MET and OLP
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftelsen Rönnbäret
- Responsible party
- Principal investigator, Wilhelmus Grooten, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891625
- Sponsor's protocol ID
- 2024-07604-01
- Status last verified
- Jul 2025
- First submitted
- 6 Mar 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be coded making it impossible to identify individuals. On request, this coded data can be shared.
Publications
Borg F, Gedin F, Franzen E, Grooten WJA. Immediate effects of spinal manipulation, exercise therapy, and open-label placebo on lifting performance and pain in individuals with chronic non-specific back pain: a motion laboratory-based crossover randomized controlled trial. Chiropr Man Therap. 2026 Oct 14;34(1):60. doi: 10.1186/s12998-026-00680-w.
PubMed 42875790
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Spinal Manipulative Therapy, Exercise Therapy and Open-label Placebo on Movement Performance in Individuals With Chronic Back Pain
- ClinicalTrials.gov ID
- NCT06891625
- Acronym / sponsor ID
- 2024-07604-01
- Conditions
- Chronic Low-back Pain, Back Disorder
- Keywords
- chiropractic, physical therapy, open-label placebo, motion capture, acute effects, pain-intensity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stiftelsen Rönnbäret
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All participants receive all treatments: SMT, MET and OLP
| Arm | Type | Receives |
|---|---|---|
| Spinal manipulation therapy (SMT) | Experimental | Other: ET, Other: OLPChiropractic treatment |
| Exercise Therapy (ET) | Experimental | Other: SMT, Other: OLPPhysical therapy treatment |
| Open Placebo (OLP) | Placebo comparator | Other: SMT, Other: ETOpen-label treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- "red flags"
- persons with specific back problems, rheumatic inflammatory joint- and/or back diseases, fractures, diagnosed hip osteoarthritis, fibromyalgia, or neurological co-morbidity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMTIn 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 | Exercise Therapy (ET), Open Placebo (OLP) |
| ETIn 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 | Open Placebo (OLP), Spinal manipulation therapy (SMT) |
| OLPIn 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". | Other | Exercise Therapy (ET), Spinal manipulation therapy (SMT) |
Primary outcome
Lifting performance
Time frame: 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.
7 secondary outcomes
Gait - 1) Temporal gait parameters
Time frame: Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.
Gait - 2) Spatial gait parameters
Time frame: 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
Time frame: Immediately after each intervention, the participants perform the gait task. The results will be compared to the baseline measures.
m-FTF
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.
mm-Schober's test
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.
Pain-Intensity
Time frame: Immediately after each intervention, the participants rate their pain-intensity ("pain right now"). The results will be compared to the baseline measures.
Preference
Time frame: Immediately after all interventions, the participants evaluate the interventions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Derived from this study: PubMed 42875790Borg F, Gedin F, Franzen E, Grooten WJA. Immediate effects of spinal manipulation, exercise therapy, and open-label placebo on lifting performance and pain in individuals with chronic non-specific back pain: a motion laboratory-based crossover randomized controlled trial. Chiropr Man Therap. 2026 Oct 14;34(1):60. doi: 10.1186/s12998-026-00680-w.
- Individual participant dataSharing planned: Yes. All data will be coded making it impossible to identify individuals. On request, this coded data can be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erika Franzen, prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMT, ET and OLP in people with Chronic Low-back Pain and Back Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wilhelmus JA Grooten, associated professor (+46-8-52488861, Wim.Grooten@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lifting performance (time frame: Immediately after each intervention, the participants perform the lifting task. The results will be compared to the baseline measures.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06891625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.