Mechanical Low Back PainNCT06209762
Investigation of the Effects of Inspiratory Muscle Training on Patients With Mechanical Low Back Pain.
A study testing Exercise in people with Mechanical Low Back Pain, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
There are many conservative treatment methods for the treatment of mechanical low back pain and they continue to be developed. The aim of this study is to examine the effects of inspiratory muscle training, which can be added to these treatment methods, on muscle endurance, functional capacity, pain intensity… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Dec 2023to 19 Mar 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be between the ages of 18-65
- Applying to the physical therapy unit with the diagnosis of mechanical low back pain (Lumbal disc herniation, spinal stenosis, spondylolisthesis, facet joint pain, discogenic pain, sacroiliac joint pain, myofascial pain, lumbar osteoarthrosis)
- Ability to adapt to exercise commands and understand assessment questions
- Volunteering to participate in research
Who cannot join
- Those with cooperation and communication problems
- Complaining of acute or chronic musculoskeletal pain other than low back pain
- Having a chronic disease (hypertension, diabetes, chronic obstructive pulmonary disease (COPD), previous cerebrovascular accident (CVO), heart, neurological and rheumatological problems)
- Sequestrated and extruded hernia
- Receiving physical therapy in the last 2 months
- Having a history of recent surgery (spine, abdomen, upper and lower extremity surgeries)
- Being obese (Body mass index ≥30 kg/m2)
- Contagious and vascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Inspiratory Muscle Training in Addition to Core Stabilization Exercises on Core Endurance, Functional Capacity, Pain Intensity, Disability, Quality of Life and Sleep Quality in Patients With Mechanical Low Back Pain.
There are many conservative treatment methods for the treatment of mechanical low back pain and they continue to be developed. The aim of this study is to examine the effects of inspiratory muscle training, which can be added to these treatment methods, on muscle endurance, functional capacity, pain intensity, disability, quality of life and sleep quality in people with mechanical low back pain.
Read the detailed description
When initial assessment will be completed, patients will be assigned to one of two possible sequences by simple randomization: study group (SG) or control group (CG).
All participants will receive the core stabilization exercise program designed for mechanical low back pain for 8 weeks. Additionally, the study group will receive inspiratory muscle training for 8 weeks.
All studies will be evaluated both at the beginning and end of the study in terms of pain, quality of life, sleep quality, disability level, muscle endurance and functional capacity. All data will be collected by the same physiotherapist at baseline and at the end of the study (8 weeks). The same physiotherapist will also supervise the exercises and inspiratory training.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Exercise
- Keywords
- Mechanical Low Back Pain, Inspiratuar Muscle Training, Core Stabilization Exercise
- 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.
ExerciseOther
The core stabilization exercise program, which is individually prescribed and structured, will be applied for 8 weeks. The level of exercises will be increased over time according to the patient's condition. Exercises will be taught to patients. It will be carried out under the supervision of a physiotherapist three days a week for 8 weeks. On the remaining days, the patient will be asked to do it himself.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Other: Exercise |
| Inspiratuar Muscle Education Group | Experimental | Patients in this group will have 10 repetitions of slow diaphragmatic deep breathing exercises followed by core stabilization exercises. Then, IMT will be applied with a respiratory muscle training device. In this training, the difficulty of the exercise will be increased by starting from 40% of the MIP value measured during the evaluation and following the values of 60% and 80% according to tolerance. In addition to physical therapy sessions three days a week for eight weeks, patients will be asked to do this exercise five days a week in the morning and evening. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Pain intensity will be measured with this scale.
Measured: 8 weeks
Oswestry Disability Index
Disability level will be measured with this scale
Measured: 8 weeks
Maximum Inspiratuar Pressure
It will be used to evaluate participants' inspiratory muscle strength.
Measured: 8 weeks
Core Activation
It will be used to evaluate the participants' core muscle strength.
Measured: 8 weeks
2 Minute Walking Test
It will be used to evaluate the functional capacity of participants.
Measured: 8 weeks
Pittsburgh Sleep Quality Index
It will be used to evaluate participants' sleep quality.
Measured: 8 weeks
Short-Form 12
It will be used to evaluate participants' quality of life.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start26 Dec 2023
- Primary completion20 Feb 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209762
- Sponsor's protocol ID
- GulceB
- Status last verified
- Jul 2024
- First submitted
- 5 Jan 2024
- Last updated
- 8 Jul 2024
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Inspiratory Muscle Training in Addition to Core Stabilization Exercises on Core Endurance, Functional Capacity, Pain Intensity, Disability, Quality of Life and Sleep Quality in Patients With Mechanical Low Back Pain.
- ClinicalTrials.gov ID
- NCT06209762
- Acronym / sponsor ID
- GulceB
- Conditions
- Mechanical Low Back Pain
- Keywords
- Mechanical Low Back Pain, Inspiratuar Muscle Training, Core Stabilization Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 17 Jan 2024 (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.
There are many conservative treatment methods for the treatment of mechanical low back pain and they continue to be developed. The aim of this study is to examine the effects of inspiratory muscle training, which can be added to these treatment methods, on muscle endurance, functional capacity, pain intensity, disability, quality of life and sleep quality in people with mechanical low back pain.
Detailed description
When initial assessment will be completed, patients will be assigned to one of two possible sequences by simple randomization: study group (SG) or control group (CG).
All participants will receive the core stabilization exercise program designed for mechanical low back pain for 8 weeks. Additionally, the study group will receive inspiratory muscle training for 8 weeks.
All studies will be evaluated both at the beginning and end of the study in terms of pain, quality of life, sleep quality, disability level, muscle endurance and functional capacity. All data will be collected by the same physiotherapist at baseline and at the end of the study (8 weeks). The same physiotherapist will also supervise the exercises and inspiratory training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Exercise |
| Inspiratuar Muscle Education Group | Experimental | Other: ExercisePatients in this group will have 10 repetitions of slow diaphragmatic deep breathing exercises followed by core stabilization exercises. Then, IMT will be applied with a respiratory muscle training device. In this training, the difficulty of the exercise will be increased by starting from 40% of the MIP value measured during the evaluation and following the values of 60% and 80% according to tolerance. In addition to physical therapy sessions three days a week for eight weeks, patients will be asked to do this exercise five days a week in the morning and evening. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be between the ages of 18-65
- Applying to the physical therapy unit with the diagnosis of mechanical low back pain (Lumbal disc herniation, spinal stenosis, spondylolisthesis, facet joint pain, discogenic pain, sacroiliac joint pain, myofascial pain, lumbar osteoarthrosis)
- Ability to adapt to exercise commands and understand assessment questions
- Volunteering to participate in research
Key exclusion criteria (8 listed)
- Those with cooperation and communication problems
- Complaining of acute or chronic musculoskeletal pain other than low back pain
- Having a chronic disease (hypertension, diabetes, chronic obstructive pulmonary disease (COPD), previous cerebrovascular accident (CVO), heart, neurological and rheumatological problems)
- Sequestrated and extruded hernia
- Receiving physical therapy in the last 2 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 |
|---|---|---|
| ExerciseThe core stabilization exercise program, which is individually prescribed and structured, will be applied for 8 weeks. The level of exercises will be increased over time according to the patient's condition. Exercises will be taught to patients. It will be carried out under the supervision of a physiotherapist three days a week for 8 weeks. On the remaining days, the patient will be asked to do it himself. | Other | Control Group, Inspiratuar Muscle Education Group |
Primary outcome
Visual Analog Scale
Time frame: 8 weeks
Pain intensity will be measured with this scale.
Oswestry Disability Index
Time frame: 8 weeks
Disability level will be measured with this scale
Maximum Inspiratuar Pressure
Time frame: 8 weeks
It will be used to evaluate participants' inspiratory muscle strength.
Core Activation
Time frame: 8 weeks
It will be used to evaluate the participants' core muscle strength.
2 Minute Walking Test
Time frame: 8 weeks
It will be used to evaluate the functional capacity of participants.
Pittsburgh Sleep Quality Index
Time frame: 8 weeks
It will be used to evaluate participants' sleep quality.
Short-Form 12
Time frame: 8 weeks
It will be used to evaluate participants' quality of life.
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 8 Jul 2024.
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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 Exercise in people with Mechanical Low Back Pain, run by Yeditepe University at 1 site in Turkey (Türkiye).
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 4 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 8 Jul 2024. 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 Turkey (Türkiye). 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?
Visual Analog Scale (time frame: 8 weeks). The study lists 7 primary outcomes in all. 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 8 Jul 2024.