Core Stability Exercise Versus Diaphragmatic Release on Respiratory Functions on Physical Therapists With Low Back Pain

NCT ID: NCT05860283

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-04
• Study Completion Date: 2024-08-01

Brief Summary

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.

Conditions

Mechanical Low Back Pain; Respiratory Functions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Core stabilization exercise group

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.

Group Type: ACTIVE_COMPARATOR

Core stabilization exercise using pressure biofeedback unit

Intervention Type: DEVICE

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 group

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.

Group Type: ACTIVE_COMPARATOR

Diaphragmatic release technique

Intervention Type: PROCEDURE

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.

Control group

The subjects in this group will receive traditional physical therapy program only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Core stabilization exercise using pressure biofeedback unit

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.

Intervention Type: DEVICE

Diaphragmatic release technique

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sumaya Serageldin Mohamed

Physical therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaa El-Moatasem, Doctoral

Role: STUDY_DIRECTOR

Departement of Cardiovascular Respiratory Disorder and Geriatrics- Faculty of Physical Therapy- Cairo University

Rehab ElSawy, doctoral

Role: STUDY_DIRECTOR

Chest Diseases Departement - Faculty of Medicine - Benha University

Locations

Faculty of physical therapy- Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Respiratory functions in LBP

Identifier Type: -

Identifier Source: org_study_id