Low Back PainNCT03270631
Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain
A study testing FM and MCE in people with Low Back Pain and Low Back Pain, Recurrent, run by Oulu University Hospital at 1 site in Finland.
Trial summary
Subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in University Hospital of Oulu at Physical and Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Back Pain, Low Back Pain, Recurrent
- What is being tested?
- FM and MCE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteFinland
- Study dates
- 28 Aug 2017to 31 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chronic non-operatively treated low back pain or pain after the low back operation. Participation in multidisciplinary rehabilitation at University Hospital of Oulu.
Who cannot join
- Specific low back pain cause and earlier fascial manipulation treatment given.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain in Conjunction With Multidisciplinary Rehabilitation - a RCT
Subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in University Hospital of Oulu at Physical and Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor at PRM unit. The volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. After that the subjects are measured at baseline measurement. Subjects are randomized into the five groups. After the 3 months treatment and training the follow-up measurements are performed. Same questionnaires are filled in at that point as well. At 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.
Read the detailed description
Subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in University Hospital of Oulu at Physical and Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor at PRM unit. The volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. After that the subjects are measured at baseline measurement. Subjects are randomized into the five groups: 1) control group, 2) fascial manipulation (FM) and movement control exercises (MCE), 3) sham-FM and MCE, 4) FM and sham-MCE and 5) sham-FM and sham-MCE. Physical therapists who perform treatments (FM), prescribing MCE and performing the measurements are blinded to each other. Physical therapist who is performing measurements is also blinded for the baseline measurements. There and 4 treatments of sham-FM, 4-5 treatments of FM, 4 treatments of sham-MCE and 4-6 treatments of MCE. Control group will receive only university hospital rehabilitation and will participate into the baseline and follow-up measurements. After the 3 months treatment and training the follow-up measurements are performed. Same questionnaires are filled in as at baseline. At 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.
- Conditions
- Low Back Pain, Low Back Pain, Recurrent
- Being tested
- FM and MCE, FM and sham-MCE, MCE and sham-FM, Sham-MCE and sham-FM
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FM and MCEOther
Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting.
FM and sham-MCEOther
Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises.
MCE and sham-FMOther
Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting. Sham-FM is similar to trigger point treatment with treated points randomized.
Sham-MCE and sham-FMOther
Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Multidisciplinary rehabilitation, no interventions |
| FM and MCE | Experimental | Subjects will have 4-5 times of fascial manipulation (FM) treatment and 4-6 times movement control exercises (MCE) at home to be done based on movement control testing (MCT). Both are given in 3 month period. Receives: Other: FM and MCE |
| FM and sham-MCE | Other | FM 4-5 times in 3 months and 4 general exercise prescription. Receives: Other: FM and sham-MCE |
| MCE and sham-FM | Other | Sham-FM 4 times in 3 months including trigger point treatment in before decided points and 4-6 times MCE prescription and home exercises. Receives: Other: MCE and sham-FM |
| Sham-MCE and sham-FM | Sham comparator | 4 general practice guiding and Sham-FM 4 times in 3 months including trigger point treatment in before decided points. Receives: Other: Sham-MCE and sham-FM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Specific Functional Scale (PSFS)
Three different meaningful tasks will be rated from 0 to 10 as how hard is the task.
Measured: Baseline, 3, 6 and 12 months
Secondary outcomes (13)
Change in Oswestry
Disability index
Measured: Baseline, 3, 6 and 12 months
Change in PROMIS
Quality of life
Measured: Baseline, 3, 6 and 12 months
Change in Tampa Scale of Kinesiophobia
Fear of movement
Measured: Baseline, 3, 6 and 12 months
Change in Visual analogue Scale
Pain scale
Measured: Baseline, 3, 6 and 12 months
Change in Linton Örebro
Psychosocial risk factor
Measured: Baseline, 3, 6 and 12 months
Change in Start back
Screening tool of the psychosocial risk factors
Measured: Baseline, 3, 6 and 12 months
Change in Movement control tests
Clinical tests for LBP
Measured: Change from baseline at 3 month
Change in Spinal mouse
Mobility of the spine
Measured: Change from baseline at 3 month
Change in Balance measured with computer
Power plate
Measured: Change from baseline at 3 month
Change in Mobility of the hips
Hip ROM
Measured: Change from baseline at 3 month
Change in Two-point discrimination
How far apart subject is able to feel two distinctive point of touch
Measured: Change from baseline at 3 month
Change in Lef-right discrimination
How subject is able to understand right and left of the back
Measured: Change from baseline at 3 month
Change in Ultrasound of the fascia
Several fascial structures are measured
Measured: Change from baseline at 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start28 Aug 2017
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Five groups: 1) control, 2) fascial manipulation (FM) + movement control exercise (MCE), 3) FM + sham-MCE, 4) MCE + sham-FM and 5) sham-FM and sham-MCE
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Loisto Terveys, Oulu, Fysios Kastelli, Oulu, Faskia-Markus, Oulu
- Responsible party
- Principal investigator, Jani Takatalo, Oulu University Hospital
- Investigators
- Jani Takatalo, PhD, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270631
- Sponsor's protocol ID
- FM&KCStudy
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2017
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain in Conjunction With Multidisciplinary Rehabilitation - a RCT
- ClinicalTrials.gov ID
- NCT03270631
- Acronym / sponsor ID
- FM&KCStudy
- Conditions
- Low Back Pain, Low Back Pain, Recurrent
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- Loisto Terveys, Oulu, Fysios Kastelli, Oulu, Faskia-Markus, Oulu
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 1 Sep 2017 (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.
Subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in University Hospital of Oulu at Physical and Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor at PRM unit. The volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. After that the subjects are measured at baseline measurement. Subjects are randomized into the five groups. After the 3 months treatment and training the follow-up measurements are performed. Same questionnaires are filled in at that point as well. At 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.
Detailed description
Subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in University Hospital of Oulu at Physical and Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor at PRM unit. The volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. After that the subjects are measured at baseline measurement. Subjects are randomized into the five groups: 1) control group, 2) fascial manipulation (FM) and movement control exercises (MCE), 3) sham-FM and MCE, 4) FM and sham-MCE and 5) sham-FM and sham-MCE. Physical therapists who perform treatments (FM), prescribing MCE and performing the measurements are blinded to each other. Physical therapist who is performing measurements is also blinded for the baseline measurements. There and 4 treatments of sham-FM, 4-5 treatments of FM, 4 treatments of sham-MCE and 4-6 treatments of MCE. Control group will receive only university hospital rehabilitation and will participate into the baseline and follow-up measurements. After the 3 months treatment and training the follow-up measurements are performed. Same questionnaires are filled in as at baseline. At 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Five groups: 1) control, 2) fascial manipulation (FM) + movement control exercise (MCE), 3) FM + sham-MCE, 4) MCE + sham-FM and 5) sham-FM and sham-MCE
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Multidisciplinary rehabilitation, no interventions |
| FM and MCE | Experimental | Other: FM and MCESubjects will have 4-5 times of fascial manipulation (FM) treatment and 4-6 times movement control exercises (MCE) at home to be done based on movement control testing (MCT). Both are given in 3 month period. |
| FM and sham-MCE | Other | Other: FM and sham-MCEFM 4-5 times in 3 months and 4 general exercise prescription. |
| MCE and sham-FM | Other | Other: MCE and sham-FMSham-FM 4 times in 3 months including trigger point treatment in before decided points and 4-6 times MCE prescription and home exercises. |
| Sham-MCE and sham-FM | Sham comparator | Other: Sham-MCE and sham-FM4 general practice guiding and Sham-FM 4 times in 3 months including trigger point treatment in before decided points. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic non-operatively treated low back pain or pain after the low back operation. Participation in multidisciplinary rehabilitation at University Hospital of Oulu.
Key exclusion criteria (1 listed)
- Specific low back pain cause and earlier fascial manipulation treatment given.
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 |
|---|---|---|
| FM and MCETreatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting. | Other | FM and MCE |
| FM and sham-MCETreatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises. | Other | FM and sham-MCE |
| MCE and sham-FMTreatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting. Sham-FM is similar to trigger point treatment with treated points randomized. | Other | MCE and sham-FM |
| Sham-MCE and sham-FMSham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises. | Other | Sham-MCE and sham-FM |
Primary outcome
Change in Patient Specific Functional Scale (PSFS)
Time frame: Baseline, 3, 6 and 12 months
Three different meaningful tasks will be rated from 0 to 10 as how hard is the task.
13 secondary outcomes
Change in Oswestry
Time frame: Baseline, 3, 6 and 12 months
Change in PROMIS
Time frame: Baseline, 3, 6 and 12 months
Change in Tampa Scale of Kinesiophobia
Time frame: Baseline, 3, 6 and 12 months
Change in Visual analogue Scale
Time frame: Baseline, 3, 6 and 12 months
Change in Linton Örebro
Time frame: Baseline, 3, 6 and 12 months
Change in Start back
Time frame: Baseline, 3, 6 and 12 months
Change in Movement control tests
Time frame: Change from baseline at 3 month
Change in Spinal mouse
Time frame: Change from baseline at 3 month
Change in Balance measured with computer
Time frame: Change from baseline at 3 month
Change in Mobility of the hips
Time frame: Change from baseline at 3 month
Change in Two-point discrimination
Time frame: Change from baseline at 3 month
Change in Lef-right discrimination
Time frame: Change from baseline at 3 month
Change in Ultrasound of the fascia
Time frame: Change from baseline at 3 month
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 4 Sep 2025.
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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.
Jani Takatalo, PhD principal investigator
Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FM and MCE in people with Low Back Pain and Low Back Pain, Recurrent, run by Oulu University Hospital at 1 site in Finland.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 4 Sep 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 Finland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Specific Functional Scale (PSFS) (time frame: Baseline, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2025.