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

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
General exercises
General exercises with tranversus abdmoinis contraction
Sponsored by
Ahram Canadian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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

Sites / Locations

  • Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

General Exercises

General exercises with TA contraction

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain Pressure Threshold
Pain pressure threshold is a measure of the minimum amount of pressure that causes pain in the affected area. It will be assessed using a pressure algometer.
Disability
Disability will be assessed using the Roland-Morris Disability Questionnaire, which is a self-reported questionnaire that assesses the impact of back pain on daily activities. The questionnaire includes 24 items that ask participants to rate their ability to perform various activities on a scale of 0 to 24. Higher scores indicate greater disability.
Global Perception Effect
Global perception effect is a measure of the participant's overall perception of the effectiveness of the general exercise in reducing pain and improving function. It will be assessed using a single-item question that asks participants to rate their perception of the program's effectiveness on a scale of 0 to 10. Higher scores indicate greater effectiveness.

Full Information

First Posted
April 19, 2023
Last Updated
April 30, 2023
Sponsor
Ahram Canadian University
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1. Study Identification

Unique Protocol Identification Number
NCT05838040
Brief Title
General Exercises With and Without TA Contraction in Patients With Nonspecific Acute LBP
Official Title
General Exercises With and Without TA Contraction in Patients With Nonspecific Acute LBP: A Crossover Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2023 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General Exercises
Arm Type
Active Comparator
Arm Description
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.
Arm Title
General exercises with TA contraction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
General exercises
Intervention Description
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
Intervention Name(s)
General exercises with tranversus abdmoinis contraction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity via numeric pain rating scale
Description
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.
Time Frame
Changes in pain intensity at baseline, 10 weeks after randomization, 3 and 6 months after discharge.
Secondary Outcome Measure Information:
Title
Pain Pressure Threshold
Description
Pain pressure threshold is a measure of the minimum amount of pressure that causes pain in the affected area. It will be assessed using a pressure algometer.
Time Frame
Changes at Pain pressure threshold at baseline, 10 weeks after randomization, 3 and 6 months after discharge.
Title
Disability
Description
Disability will be assessed using the Roland-Morris Disability Questionnaire, which is a self-reported questionnaire that assesses the impact of back pain on daily activities. The questionnaire includes 24 items that ask participants to rate their ability to perform various activities on a scale of 0 to 24. Higher scores indicate greater disability.
Time Frame
Changes in Disability at baseline, 10 weeks after randomization, 3 months after discharge, and 6 months after discharge.
Title
Global Perception Effect
Description
Global perception effect is a measure of the participant's overall perception of the effectiveness of the general exercise in reducing pain and improving function. It will be assessed using a single-item question that asks participants to rate their perception of the program's effectiveness on a scale of 0 to 10. Higher scores indicate greater effectiveness.
Time Frame
changes in Global perception at baseline, 10 weeks after randomization, 3 months after discharge, and 6 months after discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Somaia Hamed, Ph.d
Phone
+201159880001
Email
somaia.ali@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Fawzy, Ph.d
Organizational Affiliation
Faculty of Physical Therapy, Ahram Canadian University
Official's Role
Study Chair
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The individual participant data (IPD) collected during this study will be available upon reasonable request. Requests for access to the data should be submitted via email to mohamed.elmeligie@acu.edu.eg. All requests will be reviewed by the study investigators to ensure that they are reasonable and consistent with the ethical principles of the study. Access to the data will be granted in compliance with applicable laws and regulations, and with appropriate safeguards to protect the privacy and confidentiality of study participants.
IPD Sharing Time Frame
During the trial and after 1 year of the end of trial.
IPD Sharing Access Criteria
via email to mohamed.elmeligie@acu.edu.eg

Learn more about this trial

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

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