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

NCT05860283 | Unknown DMC

• 1 other identifier: Respiratory functions in LBP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

To compare between core stability exercise and diaphragmatic release on respiratory functions on physical therapists with low back pain.

Conditions

Mechanical Low Back Pain; Respiratory Functions

Keywords

Core stability exercises; Diaphragmatic release technique

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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.

  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.

  one year

Secondary Outcomes (3)

• Numerical pain rating scale (NPRS)

  one year

• Oswestry Disability Index (ODI)

  one year

• Pressure biofeedback unit (PBU)

  one year

Study Arms (3)

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.

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.

Procedure: Diaphragmatic release technique

Control group

NO INTERVENTION

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

Interventions

Core stabilization exercise using pressure biofeedback unit 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.

Core stabilization exercise group

Diaphragmatic release technique 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.

Diaphragmatic release group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Gender Eligibility Details: participant eligibility is based on self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy- Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alaa El-Moatasem, Doctoral

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

  STUDY DIRECTOR

• Rehab ElSawy, doctoral

  Chest Diseases Departement - Faculty of Medicine - Benha University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: May 16, 2023
• Study Start: July 4, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

EG (1)