Chronic Low-back PainNCT05268822
Movement Control Exercises With and Without Specific Breathing Techniques for the Treatment of Chronic Low Back Pain
A study testing Home exercise in people with Chronic Low-back Pain, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Chronic low back pain (CLBP) is a leading disability globally. Exercise therapies are one of the most commonly prescribed treatment options for CLBP. Specific breathing techniques have been shown to enhance brain-based pain modulation and autonomic nervous system balance; these changes have been shown to improve… Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Home exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 8 Feb 2022to 14 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-68-years-old
- Low back pain lasting more than 3 months (pain sensation more than 3 days per week)
- A numerical pain scale of more than 3
- ≥ 2/6 positive low back movement control tests (as described by Luomajoki et al.)
- Roland-Morris Disability Questionnaire score of five or greater
- Who are physically able to perform movement control tests and provide written informed consent.
Who cannot join
- Any history of malignant cancer
- Neurological disease affecting the central nervous system (MS, dementia)
- Rheumatic disease (fibromyalgia, ankylosing spondylitis/rheumatoid arthritis)
- Chronic obstructive pulmonary disease,
- Spinal surgery in the last 12 months
- A cardiac pacemaker
- Signs and symptoms of nerve root pathology during the clinic visits.
- Women who become pregnant during the data collection will also be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Private Clinic of principal investigator
Helsinki, Uusimaa, 00100
About this study
Official title: Movement Control Exercises With and Without Specific Breathing Techniques for the Treatment of Chronic Low Back Pain: an Open-label Feasibility Study With 2-month
Chronic low back pain (CLBP) is a leading disability globally. Exercise therapies are one of the most commonly prescribed treatment options for CLBP. Specific breathing techniques have been shown to enhance brain-based pain modulation and autonomic nervous system balance; these changes have been shown to improve clinical effectiveness in terms of pain management and psychological factors compared to general exercise. However, no previous studies have added a specific breathing technique protocol to an evidence-based exercise program for CLBP.
- Conditions
- Chronic Low-back Pain
- Being tested
- Home exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home exerciseOther
Movement control exercise with or without specific breathing techniques
| Study group | Role | What they receive |
|---|---|---|
| Movement control exercise with specific breathing techniques | Active comparator | Movement control exercise with specific breathing techniques (experimental group) Receives: Other: Home exercise |
| Movement control exercise without specific breathing techniques | Active comparator | Movement control exercise without specific breathing techniques (control group) Receives: Other: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The numerical pain rating scale (NRPS)
Eleven-point numerical pain scale. Scale from 0 (no pain) to 10 (worst imaginable)
Measured: Change from Baseline The numerical pain rating scale at 2 months
Well-Being in Pain Questionnaire
Self-developed questionnaire to screen the effects of pain on a person's biopsychosocial well-being. Scale from 0 (no subjective well-being in pain) to 60 (maximum subjective well-being in pain)
Measured: Change from Baseline Well-Being in Pain Questionnaire at 2 months
The Roland Morris Disability Questionnaire (RMDQ)
Questionnaire measuring disability in chronic low back pain populations. Scale from 0 (no disability) to 24 (maximum low back pain related disability)
Measured: Change from Baseline The Roland Morris Disability Questionnaire at 2 months
Central Sensitization Inventory (CSI)
Screening of central sensitization phenomenon. Scale from 0 (no central sensitization) to 100 (worst imaginable central sensitization)
Measured: Change from Baseline Central Sensitization Inventory at two months
The 5-level EQ-5D version of the EuroQol
Health status. Scale from 0 (dead) to 1 (full health)
Measured: Change from Baseline The 5-level EQ-5D version of the EuroQol at 2 months
The Generalised Anxiety Disorder Assessment (GAD-7)
Measure of generalised anxiety disorder related symptoms. Scale from 0 (the most minimal anxiety) to 21 (the most severe anxiety)
Measured: Change from Baseline The Generalised Anxiety Disorder Assessment at two months
The Tampa Scale of Kinesiophobia (TSK)
Assessment of subjective kinesiophobia (fear of movement). Scale from 17 (the minimal kinesophobia) to 68 (the most maximum kinesiophobia).
Measured: Change from Baseline The Tampa scale of Kinesiophobia at two months
The Pain Catastrophizing Scale (PCS)
Assessment of catastrophizing (tendency to magnify the threat value of a pain stimulus) related to pain. Scale from 0 (no catastrophizing thoughts) to 52 (maximum catastrophizing thoughts)
Measured: Change from Baseline he Pain Catastrophizing Scale at two months
The Pain and Sleep Questionnaire Three-Item Index (PSQ-3)
Effect of pain on sleep. Scale from 0 (pain have no any effect on sleep) to 30 (pain have maximum effect on sleep)
Measured: Change from Baseline The Pain and Sleep Questionnaire Three-Item Index at two months
The Pain Self-Efficacy Questionnaire (PSEQ)
assess the self-efficacy of people in pain have in daily activities. The scale is from 0 points (not at all confident) to 6 points (completely confident).
Measured: Change from Baseline The Pain and Sleep Questionnaire Three-Item Index at two months
Secondary outcomes (3)
Feasibility of intervention protocol, recruitment and enrollment
To assess the feasibility of the intervention protocol and subject recruitment and enrollment.
Measured: Through study completion, an average of 2 mothns
Responsiveness
To quantify the changes in and determine the responsiveness of the outcome measures, in order to calculate the sample size for a randomized controlled trial (RCT) based on the chosen primary outcome measure(s).
Measured: Through study completion, an average of 2 months
Quantifying
To quantify the changes in self-adherence levels to home exercise and monitor possible pain medication usage, and side effects, adverse events and injuries during exercise.
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start8 Feb 2022
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- An open-label feasibility study with study subject allocated to movement control exercise with specific breathing techniques (experimental group) or movement control exercise without specific breathing techniques (control group)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Jani Mikkonen, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268822
- Sponsor's protocol ID
- KuopioUH_2022
- Status last verified
- Mar 2023
- First submitted
- 8 Feb 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mikkonen J, Luomajoki H, Airaksinen O, Goubert L, Pratscher S, Leinonen V. Identical movement control exercises with and without synchronized breathing for chronic non-specific low back pain:A randomized pilot trial. J Back Musculoskelet Rehabil. 2024;37(6):1561-1571. doi: 10.3233/BMR-230413.
PubMed 39031339Mikkonen J, Luomajoki H, Airaksinen O, Goubert L, Leinonen V. Protocol of identical exercise programs with and without specific breathing techniques for the treatment of chronic non-specific low back pain: randomized feasibility trial with two-month follow-up. BMC Musculoskelet Disord. 2023 May 5;24(1):354. doi: 10.1186/s12891-023-06434-6.
PubMed 37147638
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement Control Exercises With and Without Specific Breathing Techniques for the Treatment of Chronic Low Back Pain: an Open-label Feasibility Study With 2-month
- ClinicalTrials.gov ID
- NCT05268822
- Acronym / sponsor ID
- KuopioUH_2022
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 7 Mar 2022 (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.
Chronic low back pain (CLBP) is a leading disability globally. Exercise therapies are one of the most commonly prescribed treatment options for CLBP. Specific breathing techniques have been shown to enhance brain-based pain modulation and autonomic nervous system balance; these changes have been shown to improve clinical effectiveness in terms of pain management and psychological factors compared to general exercise. However, no previous studies have added a specific breathing technique protocol to an evidence-based exercise program for CLBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- An open-label feasibility study with study subject allocated to movement control exercise with specific breathing techniques (experimental group) or movement control exercise without specific breathing techniques (control group)
| Arm | Type | Receives |
|---|---|---|
| Movement control exercise with specific breathing techniques | Active comparator | Other: Home exerciseMovement control exercise with specific breathing techniques (experimental group) |
| Movement control exercise without specific breathing techniques | Active comparator | Other: Home exerciseMovement control exercise without specific breathing techniques (control group) |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18-68-years-old
- Low back pain lasting more than 3 months (pain sensation more than 3 days per week)
- A numerical pain scale of more than 3
- ≥ 2/6 positive low back movement control tests (as described by Luomajoki et al.)
- Roland-Morris Disability Questionnaire score of five or greater
Key exclusion criteria (8 listed)
- Any history of malignant cancer
- Neurological disease affecting the central nervous system (MS, dementia)
- Rheumatic disease (fibromyalgia, ankylosing spondylitis/rheumatoid arthritis)
- Chronic obstructive pulmonary disease,
- Spinal surgery in the last 12 months
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 |
|---|---|---|
| Home exerciseMovement control exercise with or without specific breathing techniques | Other | Movement control exercise with specific breathing techniques, Movement control exercise without specific breathing techniques |
Primary outcome
The numerical pain rating scale (NRPS)
Time frame: Change from Baseline The numerical pain rating scale at 2 months
Eleven-point numerical pain scale. Scale from 0 (no pain) to 10 (worst imaginable)
Well-Being in Pain Questionnaire
Time frame: Change from Baseline Well-Being in Pain Questionnaire at 2 months
Self-developed questionnaire to screen the effects of pain on a person's biopsychosocial well-being. Scale from 0 (no subjective well-being in pain) to 60 (maximum subjective well-being in pain)
The Roland Morris Disability Questionnaire (RMDQ)
Time frame: Change from Baseline The Roland Morris Disability Questionnaire at 2 months
Questionnaire measuring disability in chronic low back pain populations. Scale from 0 (no disability) to 24 (maximum low back pain related disability)
Central Sensitization Inventory (CSI)
Time frame: Change from Baseline Central Sensitization Inventory at two months
Screening of central sensitization phenomenon. Scale from 0 (no central sensitization) to 100 (worst imaginable central sensitization)
The 5-level EQ-5D version of the EuroQol
Time frame: Change from Baseline The 5-level EQ-5D version of the EuroQol at 2 months
Health status. Scale from 0 (dead) to 1 (full health)
The Generalised Anxiety Disorder Assessment (GAD-7)
Time frame: Change from Baseline The Generalised Anxiety Disorder Assessment at two months
Measure of generalised anxiety disorder related symptoms. Scale from 0 (the most minimal anxiety) to 21 (the most severe anxiety)
The Tampa Scale of Kinesiophobia (TSK)
Time frame: Change from Baseline The Tampa scale of Kinesiophobia at two months
Assessment of subjective kinesiophobia (fear of movement). Scale from 17 (the minimal kinesophobia) to 68 (the most maximum kinesiophobia).
The Pain Catastrophizing Scale (PCS)
Time frame: Change from Baseline he Pain Catastrophizing Scale at two months
Assessment of catastrophizing (tendency to magnify the threat value of a pain stimulus) related to pain. Scale from 0 (no catastrophizing thoughts) to 52 (maximum catastrophizing thoughts)
The Pain and Sleep Questionnaire Three-Item Index (PSQ-3)
Time frame: Change from Baseline The Pain and Sleep Questionnaire Three-Item Index at two months
Effect of pain on sleep. Scale from 0 (pain have no any effect on sleep) to 30 (pain have maximum effect on sleep)
The Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Change from Baseline The Pain and Sleep Questionnaire Three-Item Index at two months
assess the self-efficacy of people in pain have in daily activities. The scale is from 0 points (not at all confident) to 6 points (completely confident).
3 secondary outcomes
Feasibility of intervention protocol, recruitment and enrollment
Time frame: Through study completion, an average of 2 mothns
Responsiveness
Time frame: Through study completion, an average of 2 months
Quantifying
Time frame: Through study completion, an average of 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Derived from this study: PubMed 39031339Mikkonen J, Luomajoki H, Airaksinen O, Goubert L, Pratscher S, Leinonen V. Identical movement control exercises with and without synchronized breathing for chronic non-specific low back pain:A randomized pilot trial. J Back Musculoskelet Rehabil. 2024;37(6):1561-1571. doi: 10.3233/BMR-230413.
- Derived from this study: PubMed 37147638Mikkonen J, Luomajoki H, Airaksinen O, Goubert L, Leinonen V. Protocol of identical exercise programs with and without specific breathing techniques for the treatment of chronic non-specific low back pain: randomized feasibility trial with two-month follow-up. BMC Musculoskelet Disord. 2023 May 5;24(1):354. doi: 10.1186/s12891-023-06434-6.
- Study web pageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home exercise in people with Chronic Low-back Pain, run by Kuopio 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 9 Mar 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The numerical pain rating scale (NRPS) (time frame: Change from Baseline The numerical pain rating scale at 2 months). The study lists 10 primary outcomes in all. 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 NCT05268822, which also lists 2 linked publications.
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 9 Mar 2023.