Effect of Lumbar Stabilization Exercises Combined With Ball and Balloon Exercise in Treatment of Chronic Non-specific Low Back Pain

NCT06265090 | Completed

• 1 other identifier: F.P.T 2307017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

\[Background\] Low back pain occurs when a poor lifestyle weakens the muscular strength of the waist and excessive loads on and tensions of the muscles create pain. Mediating muscle weakening to stabilize the trunk is an important aspect in the recovery of body function in patients with LBP \[Purpose\], this study was conducted to investigate the effect of core stability exercises combined with ball and balloon exercises on chronic non-specific low back pain. \[Subjects and Methods\] a sixty patient of chronic non-specific low back pain were randomly assigned into two groups, group (A) received core stability exercises combined with ball and balloon exercises and group (B) received core stability exercises, these exercises were performed for three times a week for four weeks. Pain was assessed by visual analogue scale (VAS). Spinal function was measured by Arabic Oswestery Disability Index (AODI) and pulmonary function was assessed by pulmonary function test including forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), FEV1/FVC, maximum voluntary ventilation (MVV) and peak expiratory flow (PEF) before and after the study. Keywords: core stability exercises, ball and balloon exercises, chronic non-specific low back pain

Conditions

Chronic Mechanical Low Back Pain

Outcome Measures

Primary Outcomes (1)

• visual analogue score

  The Visual Analogue Scale (VAS), a reliable and effective measure of pain intensity that is sensitive to variations in pain caused by clinical conditions, was used to assess the severity of the pain. At the scale's left end, a zero means there is no pain, and a 10 means the most agonizing suffering possible. A minor improvement with a change of 1.1-1.2 cm is clinically meaningful.

  pre the intervention and immediately after the intervention

Secondary Outcomes (5)

• forced expiratory volume in the first second (FEV1) in liters

  pre the intervention and immediately after the intervention

• forced vital capacity (FVC) in liters

  pre the intervention and immediately after the intervention

• FVC/FEV1 ratio

  pre the intervention and immediately after the intervention

• maximum voluntary ventilation (MVV)

  pre the intervention and immediately after the intervention

• peak expiratory flow (PEF) in liter/min

  pre the intervention and immediately after the intervention

Other Outcomes (4)

• Arabic Oswestery Disability Index (AODI) for functional assessment

  pre the intervention and immediately after the intervention

• weight

  pre the intervention only

• age

  pre the intervention only

Study Arms (2)

ball and balloon exercises

EXPERIMENTAL

Ball and balloon exercise exercises: The second group received hemibridge with ball and balloon exercise in combination to core stability exercises. Instructions 1. supine-lying position, feet up against a wall, and bend your knees as well as hips to a 90° angle. 2. Insert a ball measuring between four and six inches in diameter in the space between your knees. 3. Put your left hand upon a balloon and your right arm above your head. 4. Tilt your pelvis to make sure your tailbone is just slightly elevated off the ground while you inhale with your nose and exhale using your mouth. Keep your low back as flat as possible on the mat. Dig your heels into the wall instead of pushing your feet flat. 5. drop your left knee till it is below the level of your right, without moving your feet. the activation of your left inner thigh muscle.

Other: therapeutic exercises; Other: exercises

core stability exercises

ACTIVE COMPARATOR

Core stability exercises (CSE): Subjects in this group were handled with core stability exercises that targeted deep abdominal muscles. This included a series of exercises as well as a baseline therapeutic management of ultrasonic as well as TENS. A physiotherapist supervised these exercises. For four weeks, all groups did core stability exercises for 30 minutes three times per week.exercises. Based on the patient's success, the intensity of the individual training steadily increased with decreasing therapist support. Patients were told to contract their abdominal muscles and hold the contraction while continuing to breathe normally during each repetition of each exercise.

Other: therapeutic exercises; Other: exercises

Interventions

therapeutic exercises OTHER

Protocol of hemibridge with ball and balloon exercise Participants were given exercise called as hemibridge with ball and balloon exercise for 3 sessions over 3 days/week.

Also known as: core stability exercises

ball and balloon exercises; core stability exercises

exercises OTHER

The second group received hemibridge with ball and balloon exercise in combination to core stability exercises. Protocol of hemibridge with ball and balloon exercise The hemibridge with ball as well as balloon exercise was provided to the participants over the course of three sessions per week. Instructions 1. supine-lying position, feet up against a wall, and bend your knees as well as hips to a 90° angle. 2. Insert a ball measuring between four and six inches in diameter in the space between your knees. 3. Put your left hand upon a balloon and your right arm above your head. 4. Tilt your pelvis to make sure your tailbone is just slightly elevated off the ground while you inhale with your nose and exhale using your mouth. Keep your low back as flat as possible on the mat. Dig your heels into the wall instead of pushing your feet flat. 5. drop your left knee till it is below the level of your right, without moving your feet. the activation of your left inner thigh muscle.

Also known as: ball and balloon exercises

ball and balloon exercises; core stability exercises

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both male and female physiotherapy students of age from 18 to 25 years
• Patients with low back pain with or without referred leg pain
• Patients with low back pain more than 6 months.

You may not qualify if:

• patients with acute low back pain
• patients with lumbar disc prolapse
• patients with systemic disease or T.B 4- history with spinal fractures or spinal surgeries,
• patients with spondylolithesis,
• patients with sacroiliac dysfunction,
• osteoporotic patients
• patients with spinal deformities
• patients had previously received physical therapy treatment for low back pain in a period of six months
• patients with pulmonary diseases.

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

Delta University For Science and Technology

Al Manşūrah, Gamasah, 11152, Egypt

Location

MeSH Terms

Interventions

Exercise Therapy; Exercise

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: the participants were selected randomly without their knowledge about in experimental or control group the assessor was for assessment only and the therapist was for treatment only
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This randomized controlled experimental trial was carried out at the outpatient clinic of faculty of physical therapy, Delta University for science and technology from April 2023 to October 2023. The aims of the study and the study protocol were explained for each patient before participation in the study. All patients signed an approved informed consent form for participation in this study. Before starting the treatment program, a complete history and physical examination will be taken for all patients. Subjects: Seventy male and female physiotherapy students have chronic non-specific low back pain will be chosen from faculty of physical therapy, delta university for science and technology. The local ethics committee approved this study (Delta University for science and technology, faculty of Physical Therapy, Ethics committee F.P.T 2307017).

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 20, 2024
• Study Start: January 10, 2022
• Primary Completion: December 20, 2022
• Study Completion: January 10, 2023
• Last Updated: February 20, 2024

Record last verified: 2023-01

Locations

EG (1)