Low Back PainNCT05838040
General Exercises With and Without TA Contraction in Patients With Nonspecific Acute LBP
A study testing General exercises and General exercises with tranversus abdmoinis contraction in people with Low Back Pain, run by Ahram Canadian University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- General exercises and General exercises with tranversus abdmoinis contraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Apr 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: General Exercises With and Without TA Contraction in Patients With Nonspecific Acute LBP: A Crossover Randomised Controlled Trial
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.
Read more
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
- Being tested
- General exercises, General exercises with tranversus abdmoinis contraction
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General exercisesOther
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 tranversus abdmoinis contractionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: General exercises with tranversus abdmoinis contraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes in pain intensity at baseline, 10 weeks after randomization, 3 and 6 months after discharge.
Secondary outcomes (3)
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.
Measured: Changes at Pain pressure threshold at baseline, 10 weeks after randomization, 3 and 6 months after discharge.
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.
Measured: Changes in Disability at baseline, 10 weeks after randomization, 3 months after discharge, and 6 months after discharge.
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.
Measured: changes in Global perception at baseline, 10 weeks after randomization, 3 months after discharge, and 6 months after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start21 Apr 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study chair, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838040
- Sponsor's protocol ID
- 012/004221
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Exercises With and Without TA Contraction in Patients With Nonspecific Acute LBP: A Crossover Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05838040
- Acronym / sponsor ID
- 012/004221
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 21 Apr 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Exercises | Active comparator | Other: General exercisesThis 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. |
| General exercises with TA contraction | Experimental | Other: General exercises with tranversus abdmoinis contractionThis 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General exercisesGeneral 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. | Other | General Exercises |
| General exercises with tranversus abdmoinis contractionGeneral 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. | Other | General exercises with TA contraction |
Primary outcome
Pain intensity via numeric pain rating scale
Time frame: Changes in pain intensity at baseline, 10 weeks after randomization, 3 and 6 months after discharge.
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.
3 secondary outcomes
Pain Pressure Threshold
Time frame: Changes at Pain pressure threshold at baseline, 10 weeks after randomization, 3 and 6 months after discharge.
Disability
Time frame: Changes in Disability at baseline, 10 weeks after randomization, 3 months after discharge, and 6 months after discharge.
Global Perception Effect
Time frame: changes in Global perception at baseline, 10 weeks after randomization, 3 months after discharge, and 6 months after discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Fawzy, Ph.d study chair
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General exercises and General exercises with tranversus abdmoinis contraction in people with Low Back Pain, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity via numeric pain rating scale (time frame: Changes in pain intensity at baseline, 10 weeks after randomization, 3 and 6 months after discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.