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

NCT05838040 | Unknown

• 1 other identifier: 012/004221
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pain intensity via numeric pain rating scale

  The primary outcome measure is pain intensity, which will be assessed using a numeric pain rating scale. Participants will be asked to rate their pain intensity on a scale of 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain. Pain intensity will be measured at four time points: baseline, 10 weeks after randomization, 3 months after discharge, and 6 months after discharge. The change in pain intensity from baseline to each follow-up time point will be analyzed using appropriate statistical methods. The primary objective of the study is to determine whether the Back to Fitness Program is effective in reducing pain intensity over time.

  Changes in pain intensity at baseline, 10 weeks after randomization, 3 and 6 months after discharge.

Secondary Outcomes (3)

• Pain Pressure Threshold

  Changes at Pain pressure threshold at baseline, 10 weeks after randomization, 3 and 6 months after discharge.

• Disability

  Changes in Disability at baseline, 10 weeks after randomization, 3 months after discharge, and 6 months after discharge.

• Global Perception Effect

  changes in Global perception at baseline, 10 weeks after randomization, 3 months after discharge, and 6 months after discharge.

Study Arms (2)

General Exercises

ACTIVE COMPARATOR

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.

Other: General exercises

General exercises with TA contraction

EXPERIMENTAL

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.

Other: General exercises with tranversus abdmoinis contraction

Interventions

General exercises 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

General exercises with tranversus abdmoinis contraction 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.

General exercises with TA contraction

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals of both sexes
• Aged between 18 and 50 years
• 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)

You may not qualify if:

• Serious low back pathology
• Contraindications to exercise therapy
• Neurological signs (leg weakness)
• Specific spinal pathology (e.g., malignancy, or inflammatory joint or bone disease)
• Prior back surgery

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY CHAIR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Somaia Hamed, Ph.d

CONTACT

+201159880001; somaia.ali@acu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: April 21, 2023
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: During the trial and after 1 year of the end of trial.
• Access Criteria: via email to mohamed.elmeligie@acu.edu.eg

Locations

EG (1)