General Exercises With and Without TA Contraction in Patients With Nonspecific Acute LBP

NCT ID: NCT05838040

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-21
• Study Completion Date: 2024-01-01

Brief Summary

PURPOSE: To evaluate the effectiveness of adding transversus abdominis contraction to general exercises to treat patients with nonspecific acute low back pain.

BACKGROUND: Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. Management consists of education and reassurance, analgesic medicines, non-pharmacological therapies, and timely review. The clinical course of low back pain is often favourable; thus, many patients require little if any formal medical care. Two treatment strategies are currently used, a stepped approach beginning with more simple care that is progressed if the patient does not respond, and the use of simple risk prediction methods to individualise the amount and type of care provided. Motor control exercises, which advocate the contraction of the TrA have shown some efficacy for patients with chronic low back pain. However, the validity of this strategy for patients with acute LBP is unclear.

HYPOTHESES: there will be no significant effect of adding transversus abdominis contraction to general exercise than general exercise alone in patients with non-specific acute low back pain.

RESEARCH QUESTION: Is there a statistically significant effect of adding transversus abdominis contraction to general exercise on outcomes of patients with non-specific acute low back pain?

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

General Exercises

This exercise activates paravertebral and abdominal muscles. Because this exercise impose extra loading on the spinal tissues, the general exercise was selected on the basis of maximizing the contraction benefit/spinal loading ratio.

Group Type: ACTIVE_COMPARATOR

General exercises

Intervention Type: OTHER

General exercise is a structured exercise program designed to help individuals with back pain improve their fitness levels. The program comprises of a series of exercise classes that are led by a physiotherapist. The classes involve a combination of aerobic, strength, and flexibility exercises, and aim to improve overall physical fitness, reduce pain, and improve function. The program is specifically designed for individuals with back pain, and the exercises are tailored to meet the needs of each participant. The Back to Fitness Program is based on the principles of exercise prescription and is intended to be a safe and effective way to manage back pain through exercise.

General exercises with TA contraction

This exercise activates paravertebral and abdominal muscles. Because this exercise impose extra loading on the spinal tissues, the general exercise was selected on the basis of maximizing the contraction benefit/spinal loading ratio. The patients will be asked to contract TA will doing these exercises.

Group Type: EXPERIMENTAL

General exercises with tranversus abdmoinis contraction

Intervention Type: OTHER

General exercise is a structured exercise program designed to help individuals with back pain improve their fitness levels. The program comprises a series of exercise classes that are led by a physiotherapist. The classes involve a combination of aerobic, strength, and flexibility exercises, and aim to improve overall physical fitness, reduce pain, and improve function. The program is specifically designed for individuals with back pain, and the exercises are tailored to meet the needs of each participant. In addition to these exercises, the Back to Fitness Program includes the activation of the transverse abdominis muscle, which is an important stabilizing muscle in the core. The activation of this muscle is done through specific exercises and techniques, and is intended to improve core stability and reduce the risk of further back injuries.

Interventions

General exercises

General exercise is a structured exercise program designed to help individuals with back pain improve their fitness levels. The program comprises of a series of exercise classes that are led by a physiotherapist. The classes involve a combination of aerobic, strength, and flexibility exercises, and aim to improve overall physical fitness, reduce pain, and improve function. The program is specifically designed for individuals with back pain, and the exercises are tailored to meet the needs of each participant. The Back to Fitness Program is based on the principles of exercise prescription and is intended to be a safe and effective way to manage back pain through exercise.

Intervention Type: OTHER

General exercises with tranversus abdmoinis contraction

General exercise is a structured exercise program designed to help individuals with back pain improve their fitness levels. The program comprises a series of exercise classes that are led by a physiotherapist. The classes involve a combination of aerobic, strength, and flexibility exercises, and aim to improve overall physical fitness, reduce pain, and improve function. The program is specifically designed for individuals with back pain, and the exercises are tailored to meet the needs of each participant. In addition to these exercises, the Back to Fitness Program includes the activation of the transverse abdominis muscle, which is an important stabilizing muscle in the core. The activation of this muscle is done through specific exercises and techniques, and is intended to improve core stability and reduce the risk of further back injuries.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Individuals of both sexes

2. Aged between 18 and 50 years

3. Acute nonspecific low back pain according to The most recent guidelines for the diagnosis and management of NSLBP come from the American College of Physicians and were published in 2017. According to these guidelines, the diagnosis of acute NSLBP should be made based on the following criteria:

Acute onset of low back pain, defined as pain lasting for less than 12 weeks No specific identifiable cause of the pain (e.g., infection, malignancy, fracture, inflammatory disorder) No radicular symptoms (e.g., pain radiating down the leg) No significant neurological deficits or findings on physical examination (e.g., loss of reflexes or muscle strength)

Exclusion Criteria

1. Serious low back pathology

2. Contraindications to exercise therapy

3. Neurological signs (leg weakness)

4. Specific spinal pathology (e.g., malignancy, or inflammatory joint or bone disease)

5. Prior back surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahram Canadian University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal Fawzy, Ph.d

Role: STUDY_CHAIR

Faculty of Physical Therapy, Ahram Canadian University

Locations

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed M ElMeligie, Ph.d

Role: CONTACT

mohamed.elmeligie@acu.edu.eg

+201064442032

Somaia Hamed, Ph.d

Role: CONTACT

somaia.ali@acu.edu.eg

+201159880001

Facility Contacts

Mohamed M ElMeligie, Ph.d

Role: primary

mohamed.elmeligie@acu.edu.eg

01064442032

Other Identifiers

012/004221

Identifier Type: -

Identifier Source: org_study_id