Mechanical Low Back PainNCT05860283
Core Stability Exercise Versus Diaphragmatic Release on Respiratory Functions on Physical Therapists With Low Back Pain
A study testing Core stabilization exercise using pressure biofeedback unit and Diaphragmatic release technique in people with Mechanical Low Back Pain and Respiratory Functions, run by Cairo University at 1 site in Egypt.
Trial summary
To compare between core stability exercise and diaphragmatic release on respiratory functions on physical therapists with low back pain. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Mechanical Low Back Pain, Respiratory Functions
- What is being tested?
- Core stabilization exercise using pressure biofeedback unit and Diaphragmatic release technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jul 2023to 1 Aug 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female physical therapists from 25 to 35 years of age.
- Body mass index less than 30.
- Mechanical LBP persisting for at least 6 months upto1 year with at least three episodes of LBP symptoms for the previous six months.
- Pain score range between 3 and 7 on the Numerical Pain Rating Scale (NPRS) and able to perform the experiment procedure without symptom aggravation.
- Oswestry disability index (ODI) of 7 or higher.
- Did not participate regularly in any training program or manual therapy intervention during the last 6 months.
Who cannot join
- Current and former smokers.
- Body mass index of 30 or higher.
- Numerical pain rating scale higher than 7 as they will not be able to perform maximum contraction.
- Participants with a history of acute traumatic low back pain in previous two months.
- Lumbar, abdominal, or gynaecological surgery in the past year ,disc herniation or spinal fracture; irradiated pain to the leg; neurological , respiratory and cardiovascular pathologies and infectious health problems.
- Menstruating women, pregnancy or postpartum.
Trial locations and contacts
1 site in 1 country.
About this study
To compare between core stability exercise and diaphragmatic release on respiratory functions on physical therapists with low back pain.
Read the detailed description
Low back pain is the most frequent self-reported type of musculoskeletal pain. It is often recurrent and has important socioeconomic consequences. 99.5% of Egyptian physical therapists (PTs) suffer from work related musculoskeletal disorders (WMSDs), mainly in the lower back (69.1%) and it is more common in female than male therapists. Physical therapists are routinely exposed to work-related physically demanding tasks such as handling heavy patients, applying manual techniques and assuming sustained awkward positions, which are the most common predisposing factors for development of WMSDs.
Respiratory dysfunction is a major factor for the diagnosis and treatment of chronic LBP. This respiratory dysfunction may be related to the altered function of the diaphragm and poor coordination of deep stabilization muscles due to dysfunctional movement patterns. Respiratory dysfunction compromises the subject's ability to stabilize the spine during balancing and postural tasks. Besides diaphragmatic dysfunction, several studies have observed in chronic LBP delayed or decreased activation of lumbar multifidi and transversus abdominus during gait and extremity movement. Since it is difficult to isolate contraction of the transversus abdominis required for the core stability exercises, biofeedback strategies using pressure biofeedback unit (PBU) will be used. This instrument allows visual detection of pressure fluctuations inherent to movements in that region. Another clinical use for the PBU is to help train lumbopelvic stability in individuals with chronic LBP during open-chain segmental control exercises, through challenging the motor control by active movements of the upper or lower limbs, meanwhile the individuals should maintain lumbopelvic neutral position known by getting visual feedback of maintenance of a steady pressure.
People with LBP have an abnormal diaphragm position impacted by small diaphragmatic excursions (mobility) with respiration, in other words "the diaphragm is splinted". Diaphragm tightness can promote shallow breathing, resulting in decreased diaphragm contractile force that impacts the diaphragm strength. Diaphragmatic release has an immediate effect on the diaphragm strength. Increased diaphragm strength immediately follows the intervention, suggesting utility of these techniques for patients with diaphragmatic movement restrictions or breathing-related disorders.
By reviewing the literature it was found that both core stability exercises and diaphragmatic release techniques have positive effects on both respiratory variables \& low back pain. Thus, the present study will compare between these two interventions.
- Conditions
- Mechanical Low Back Pain, Respiratory Functions
- Being tested
- Core stabilization exercise using pressure biofeedback unit, Diaphragmatic release technique
- Keywords
- Core stability exercises, Diaphragmatic release technique
- 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.
Core stabilization exercise using pressure biofeedback unitDevice
From crook lying:
- 1st and 2nd weeks LEVEL 1: ADIM and hold for 10 seconds LEVEL 2 : Hold for 5 sec. Repeat 10 times. Opposite lower extremity on plinth; bent leg fall out.
- 3rd and 4th week LEVEL 3 : Opposite lower extremity on plinth a)Lift bend leg to 90˚ hip flexion b)Slide heel to extend knee c)Lift straight leg to 45˚.
- 5th and 6th weeks LEVEL 4 : Hold opposite lower extremity at 90˚ of hip flexion a)Lift bend leg to 90˚ hip flexion b)Slide heel to extend knee c)Lift straight leg to 45˚.
From prone lying:
Extension of each lower extremity. The exercise progression each week will be evaluated.Each exercise session lasted 20 min. The patients had to hold each exercise for 10 seconds, three sets per session and each set 10 repetitions.
Diaphragmatic release techniqueProcedure or surgery
This technique will be given 3 days per week for 6 weeks with total technique duration of 45 minutes. The maneuver will be repeated in 4 sets per session, each set will consist of 5 deep breaths with 2-min intervals in between sets.
| Study group | Role | What they receive |
|---|---|---|
| Core stabilization exercise group | Active comparator | Core muscle activation exercises will be done using the pressure biofeedback unit. The session will include visual, auditory \& tactile biofeedback. Visual monitoring of the pressure gauge by the subjects during the exercise will be allowed and breath holding or compensatory movements will be avoided. Receives: Device: Core stabilization exercise using pressure biofeedback unit |
| Diaphragmatic release group | Active comparator | The subjects will lay supine with relaxed limbs. Positioned at the head of the subjects, there will be manual contact with the pisiform, hypothenar region and the last three fingers bilaterally to the underside of the seventh to tenth rib costal cartilages, with the forearms aligned toward the subject's shoulders. In the inspiratory phase, a gentle pull will be given at the points of contact with both hands in the direction of the head and slightly laterally, accompanying the elevation of the ribs. During exhalation, a deepened contact will be given towards the inner costal margin, to resist the rebounding movement of the thoracic cage. In the subsequent respiratory cycles, there will be a progressive increase in the depth of contact inside the costal margin. Receives: Procedure: Diaphragmatic release technique |
| Control group | No intervention | The subjects in this group will receive traditional physical therapy program only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function tests
Test will be performed with a spirometer device. Forced vital capacity (FVC) in litres, forced expiratory volume in 1st second (FEV1) in litres, the ratio between FEV1/FVC in litres, peak expiratory flow rate (PEFR) in litres/min and minute volume ventilation (MVV) in litres/min will be measured by spirometer
Measured: one year
The diaphragm excursion and thickness
They will be assessed with ultrasound M-mode and B-modes, respectively.Diaphragm excursion ( in cm) will be taken during both quiet breathing (QB) and deep breathing (DB). The diaphragm thickness (in mm) will be measured at the end of inspiration (Tins) and expiration (Texp) during DB. Diaphragm thickness change is calculated by this formula: (Tins _ Texp)/Texp *100.
Measured: one year
Total Faulty Breathing Scale (TFBS)
Total faulty breathing scale will be used to assess faulty breathing pattern during quiet and deep breathing in an upright standing position. The presence or absence of faulty breathing is the outcome variable, to be assessed by observation of lifting of the clavicle, lateral rib motion, and abdominal movement which will be categorized on a scale of normal (0), mild (1-4), moderate (5-8), and severe (9-12). Higher scores indicate a worse outcome.
Measured: one year
Chest expansion
It will be measured (in cm) using a tape measure. The three positions for measurement will be: 1) the upper chest, under the armpit mid-sternal line; 2) the lower chest, the xiphoid process mid-sternal line; and 3) the abdomen, at the umbilical area.
Measured: one year
Secondary outcomes (3)
Numerical pain rating scale (NPRS)
Numerical pain rating scale is for rating pain intensity. Subjects will be asked to score the pain intensity over the last 24 hours on the NPRS. The scale range between 0 and 10, with 0 being no pain and 10 being worst pain.
Measured: one year
Oswestry Disability Index (ODI)
Oswestry disability index is a clinical assessment tool that will provide an estimate of LBP disability expressed as a percentage score.It consists of ten sections or items to assess pain, personal care, lifting, walking, sitting, standing, sleeping, sex life (if applicable), social life and travelling. Each item is scaled from 0 to 5. The rating is: "Patient Score = (Patient's score/Possible maximum score) × 100". A score of 0% means minimal disability, and a score of 100% means bed addiction. High scores in this scale indicate worse outcomes.
Measured: one year
Pressure biofeedback unit (PBU)
A three-chamber air-filled pressure cell, a catheter and a sphygmomanometer gauge used to assess core stability (in mmHg). The subjects will perform the Sahrmann five level core stability test. The starting pressure during this test is 40 mmHg and the subjects should be able to maintain this pressure in all the 5 levels of the test while performing abdominal drawing in maneuver for 10 seconds. Compensatory postures (holding of breath, movement of the pelvis, visible, or evident contraction of the External oblique muscle, and pressing of the heels toward the floor) indicates weak core muscles.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start4 Jul 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
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.
- More trials run by Cairo UniversityThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumaya Serageldin Mohamed, Cairo University
- Investigators
- Alaa El-Moatasem, Doctoral, Study director, Departement of Cardiovascular Respiratory Disorder and Geriatrics- Faculty of Physical Therapy- Cairo UniversityRehab ElSawy, doctoral, Study director, Chest Diseases Departement - Faculty of Medicine - Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860283
- Sponsor's protocol ID
- Respiratory functions in LBP
- Status last verified
- Jul 2023
- First submitted
- 18 Mar 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Stability Exercise Versus Diaphragmatic Release on Respiratory Functions on Physical Therapists With Low Back Pain
- ClinicalTrials.gov ID
- NCT05860283
- Acronym / sponsor ID
- Respiratory functions in LBP
- Conditions
- Mechanical Low Back Pain, Respiratory Functions
- Keywords
- Core stability exercises, Diaphragmatic release technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 16 May 2023 (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.
To compare between core stability exercise and diaphragmatic release on respiratory functions on physical therapists with low back pain.
Detailed description
Low back pain is the most frequent self-reported type of musculoskeletal pain. It is often recurrent and has important socioeconomic consequences. 99.5% of Egyptian physical therapists (PTs) suffer from work related musculoskeletal disorders (WMSDs), mainly in the lower back (69.1%) and it is more common in female than male therapists. Physical therapists are routinely exposed to work-related physically demanding tasks such as handling heavy patients, applying manual techniques and assuming sustained awkward positions, which are the most common predisposing factors for development of WMSDs.
Respiratory dysfunction is a major factor for the diagnosis and treatment of chronic LBP. This respiratory dysfunction may be related to the altered function of the diaphragm and poor coordination of deep stabilization muscles due to dysfunctional movement patterns. Respiratory dysfunction compromises the subject's ability to stabilize the spine during balancing and postural tasks. Besides diaphragmatic dysfunction, several studies have observed in chronic LBP delayed or decreased activation of lumbar multifidi and transversus abdominus during gait and extremity movement. Since it is difficult to isolate contraction of the transversus abdominis required for the core stability exercises, biofeedback strategies using pressure biofeedback unit (PBU) will be used. This instrument allows visual detection of pressure fluctuations inherent to movements in that region. Another clinical use for the PBU is to help train lumbopelvic stability in individuals with chronic LBP during open-chain segmental control exercises, through challenging the motor control by active movements of the upper or lower limbs, meanwhile the individuals should maintain lumbopelvic neutral position known by getting visual feedback of maintenance of a steady pressure.
People with LBP have an abnormal diaphragm position impacted by small diaphragmatic excursions (mobility) with respiration, in other words "the diaphragm is splinted". Diaphragm tightness can promote shallow breathing, resulting in decreased diaphragm contractile force that impacts the diaphragm strength. Diaphragmatic release has an immediate effect on the diaphragm strength. Increased diaphragm strength immediately follows the intervention, suggesting utility of these techniques for patients with diaphragmatic movement restrictions or breathing-related disorders.
By reviewing the literature it was found that both core stability exercises and diaphragmatic release techniques have positive effects on both respiratory variables \& low back pain. Thus, the present study will compare between these two interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Core stabilization exercise group | Active comparator | Device: Core stabilization exercise using pressure biofeedback unitCore muscle activation exercises will be done using the pressure biofeedback unit. The session will include visual, auditory \& tactile biofeedback. Visual monitoring of the pressure gauge by the subjects during the exercise will be allowed and breath holding or compensatory movements will be avoided. |
| Diaphragmatic release group | Active comparator | Procedure: Diaphragmatic release techniqueThe subjects will lay supine with relaxed limbs. Positioned at the head of the subjects, there will be manual contact with the pisiform, hypothenar region and the last three fingers bilaterally to the underside of the seventh to tenth rib costal cartilages, with the forearms aligned toward the subject's shoulders. In the inspiratory phase, a gentle pull will be given at the points of contact with both hands in the direction of the head and slightly laterally, accompanying the elevation of the ribs. During exhalation, a deepened contact will be given towards the inner costal margin, to resist the rebounding movement of the thoracic cage. In the subsequent respiratory cycles, there will be a progressive increase in the depth of contact inside the costal margin. |
| Control group | No intervention | –The subjects in this group will receive traditional physical therapy program only. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female physical therapists from 25 to 35 years of age.
- Body mass index less than 30.
- Mechanical LBP persisting for at least 6 months upto1 year with at least three episodes of LBP symptoms for the previous six months.
- Pain score range between 3 and 7 on the Numerical Pain Rating Scale (NPRS) and able to perform the experiment procedure without symptom aggravation.
- Oswestry disability index (ODI) of 7 or higher.
Key exclusion criteria (6 listed)
- Current and former smokers.
- Body mass index of 30 or higher.
- Numerical pain rating scale higher than 7 as they will not be able to perform maximum contraction.
- Participants with a history of acute traumatic low back pain in previous two months.
- Lumbar, abdominal, or gynaecological surgery in the past year ,disc herniation or spinal fracture; irradiated pain to the leg; neurological , respiratory and cardiovascular pathologies and infectious health problems.
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 |
|---|---|---|
| Core stabilization exercise using pressure biofeedback unitFrom crook lying: * 1st and 2nd weeks LEVEL 1: ADIM and hold for 10 seconds LEVEL 2 : Hold for 5 sec. Repeat 10 times. Opposite lower extremity on plinth; bent leg fall out. * 3rd and 4th week LEVEL 3 : Opposite lower extremity on plinth a)Lift bend leg to 90˚ hip flexion b)Slide heel to extend knee c)Lift straight leg to 45˚. * 5th and 6th weeks LEVEL 4 : Hold opposite lower extremity at 90˚ of hip flexion a)Lift bend leg to 90˚ hip flexion b)Slide heel to extend knee c)Lift straight leg to 45˚. From prone lying: Extension of each lower extremity. The exercise progression each week will be evaluated.Each exercise session lasted 20 min. The patients had to hold each exercise for 10 seconds, three sets per session and each set 10 repetitions. | Device | Core stabilization exercise group |
| Diaphragmatic release techniqueThis technique will be given 3 days per week for 6 weeks with total technique duration of 45 minutes. The maneuver will be repeated in 4 sets per session, each set will consist of 5 deep breaths with 2-min intervals in between sets. | Procedure or surgery | Diaphragmatic release group |
Primary outcome
Pulmonary Function tests
Time frame: one year
Test will be performed with a spirometer device. Forced vital capacity (FVC) in litres, forced expiratory volume in 1st second (FEV1) in litres, the ratio between FEV1/FVC in litres, peak expiratory flow rate (PEFR) in litres/min and minute volume ventilation (MVV) in litres/min will be measured by spirometer
The diaphragm excursion and thickness
Time frame: one year
They will be assessed with ultrasound M-mode and B-modes, respectively.Diaphragm excursion ( in cm) will be taken during both quiet breathing (QB) and deep breathing (DB). The diaphragm thickness (in mm) will be measured at the end of inspiration (Tins) and expiration (Texp) during DB. Diaphragm thickness change is calculated by this formula: (Tins _ Texp)/Texp *100.
Total Faulty Breathing Scale (TFBS)
Time frame: one year
Total faulty breathing scale will be used to assess faulty breathing pattern during quiet and deep breathing in an upright standing position. The presence or absence of faulty breathing is the outcome variable, to be assessed by observation of lifting of the clavicle, lateral rib motion, and abdominal movement which will be categorized on a scale of normal (0), mild (1-4), moderate (5-8), and severe (9-12). Higher scores indicate a worse outcome.
Chest expansion
Time frame: one year
It will be measured (in cm) using a tape measure. The three positions for measurement will be: 1) the upper chest, under the armpit mid-sternal line; 2) the lower chest, the xiphoid process mid-sternal line; and 3) the abdomen, at the umbilical area.
3 secondary outcomes
Numerical pain rating scale (NPRS)
Time frame: one year
Oswestry Disability Index (ODI)
Time frame: one year
Pressure biofeedback unit (PBU)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
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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.
Alaa El-Moatasem, Doctoral study director
Departement of Cardiovascular Respiratory Disorder and Geriatrics- Faculty of Physical Therapy- Cairo University
Rehab ElSawy, doctoral study director
Chest Diseases Departement - Faculty of Medicine - Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stabilization exercise using pressure biofeedback unit and Diaphragmatic release technique in people with Mechanical Low Back Pain and Respiratory Functions, run by Cairo University at 1 site in Egypt.
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 6 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: status not confirmed, as of the sponsor's last update on 13 Jul 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 Egypt. 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?
Results are not available in the source record.
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?
Pulmonary Function tests (time frame: one year). The study lists 4 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 13 Jul 2023.