Low Back Pain, MechanicalNCT05257421
The Immediate Effect Of Shockwave Therapy On the Quadratus Lumborum (QL) Muscle Trigger Points vs Regular Back Exercises in Chronic Nonspecific Low Back Pain
A study testing shockwave machine, leg and back exercises and shockwave and exercises in people with Low Back Pain, Mechanical, run by University of Sharjah.
Trial summary
the study aims to compare the effect of regular back exercises with shockwave therapy by treating male patients with non-specific low back pain between the age of (20-40). Who will be devided into 3 groups, and will be treated by shockwave therapy , exercises or both combined. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men only
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- shockwave machine, leg and back exercises and shockwave and exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Aug 2022
- 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 20 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Only male patients will be included.
- Age 20-40 years old.
- Non-specific LBP for at least 3 months.
- At least one local tenderness or active trigger point in the anatomical region of the QL muscle.
- Pain intensity on numerical pain scale should be more than 4
Who cannot join
- LBP due to a pathology or trauma.
- Below 20 years of age.
- Previous lumbar surgeries.
- Malignancy.
- Patients under medications or painkillers.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Immediate Effect Of Shockwave Therapy On the Quadratus Lumborum (QL) Muscle Trigger Points vs Regular Back Exercises in Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
the study aims to compare the effect of regular back exercises with shockwave therapy by treating male patients with non-specific low back pain between the age of (20-40). Who will be devided into 3 groups, and will be treated by shockwave therapy , exercises or both combined. After signing a consent form, patients will be assigned to the groups blindly, so the patients will not know if they are in the experimental or control group.
Hypothesis:
The hypothesis of this study states that:
- Research hypothesis: there will be a significant difference between the radial ESWT and back exercises in reducing LBP
- Conditions
- Low Back Pain, Mechanical
- Being tested
- shockwave machine, leg and back exercises, shockwave and exercises
- 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.
shockwave machineDevice
shockwave therapy. 2000 impulses will be applied, 1000 on the TrPs and 1000 surrounding it, with Energy level up to 2,5 bars and frequency of 10Hz
leg and back exercisesOther
the exercise program will include 5 exercises that focuses on the back and lower limbs. These exercises are:
- Bridge
- Plank
- Squat
- Push-ups
- Back extension Each exercise will be done for 3-5 sets.
shockwave and exercisesCombination product
both types of interventions will be applied for the patient
| Study group | Role | What they receive |
|---|---|---|
| shockwave group | Experimental | Not described Receives: Device: shockwave machine |
| exercise group | Active comparator | Not described Receives: Other: leg and back exercises |
| combined group | Active comparator | Not described Receives: Combination Product: shockwave and exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure-pain threshold
Algometry device will be used to measure three thresholds' values:
- Tenderness threshold.
- Referred pain threshold.
- Pain tolerance threshold.
Measured: 45 hour session
The Oswestry Disability Index
is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability, scoring from 0 to 50, the lower score the better
Measured: 45 minutes session
Numerical pain scale
0-10 the lower the better
Measured: 45 minutes session
Secondary outcomes (1)
ROM of the back
an electrical goniometer will be used to measure the change in the back ROM
Measured: 45 minutes session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study startMay 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Mohammed Taha Makki, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257421
- Sponsor's protocol ID
- ESWTQLRCT2022
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Epidemiological features of chronic low-back pain
Joshi S, Sheth M. Effect of extracorporeal shockwave therapy on myofascial pain syndrome of upper trapezius: A systematic review. Int J Med Sci Public Health. 2020;9(10):1.
Effect of Static Versus Dynamic Ultrasound on Pain in Subjects with Trigger Point in Quadratus Lumborum Having Non-Specific Chronic Low Back. 2020;10(December):263-9.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effect Of Shockwave Therapy On the Quadratus Lumborum (QL) Muscle Trigger Points vs Regular Back Exercises in Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05257421
- Acronym / sponsor ID
- ESWTQLRCT2022
- Conditions
- Low Back Pain, Mechanical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 25 Feb 2022 (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.
the study aims to compare the effect of regular back exercises with shockwave therapy by treating male patients with non-specific low back pain between the age of (20-40). Who will be devided into 3 groups, and will be treated by shockwave therapy , exercises or both combined. After signing a consent form, patients will be assigned to the groups blindly, so the patients will not know if they are in the experimental or control group.
Hypothesis:
The hypothesis of this study states that:
- Research hypothesis: there will be a significant difference between the radial ESWT and back exercises in reducing LBP
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| shockwave group | Experimental | Device: shockwave machine |
| exercise group | Active comparator | Other: leg and back exercises |
| combined group | Active comparator | Combination Product: shockwave and exercises |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Only male patients will be included.
- Age 20-40 years old.
- Non-specific LBP for at least 3 months.
- At least one local tenderness or active trigger point in the anatomical region of the QL muscle.
- Pain intensity on numerical pain scale should be more than 4
Key exclusion criteria (5 listed)
- LBP due to a pathology or trauma.
- Below 20 years of age.
- Previous lumbar surgeries.
- Malignancy.
- Patients under medications or painkillers.
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 |
|---|---|---|
| shockwave machineshockwave therapy. 2000 impulses will be applied, 1000 on the TrPs and 1000 surrounding it, with Energy level up to 2,5 bars and frequency of 10Hz | Device | shockwave group |
| leg and back exercisesthe exercise program will include 5 exercises that focuses on the back and lower limbs. These exercises are: * Bridge * Plank * Squat * Push-ups * Back extension Each exercise will be done for 3-5 sets. | Other | exercise group |
| shockwave and exercisesboth types of interventions will be applied for the patient | Combination product | combined group |
Primary outcome
pressure-pain threshold
Time frame: 45 hour session
Algometry device will be used to measure three thresholds' values: * Tenderness threshold. * Referred pain threshold. * Pain tolerance threshold.
The Oswestry Disability Index
Time frame: 45 minutes session
is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability, scoring from 0 to 50, the lower score the better
Numerical pain scale
Time frame: 45 minutes session
0-10 the lower the better
1 secondary outcome
ROM of the back
Time frame: 45 minutes session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- BackgroundEpidemiological features of chronic low-back pain
- BackgroundJoshi S, Sheth M. Effect of extracorporeal shockwave therapy on myofascial pain syndrome of upper trapezius: A systematic review. Int J Med Sci Public Health. 2020;9(10):1.
- BackgroundEffect of Static Versus Dynamic Ultrasound on Pain in Subjects with Trigger Point in Quadratus Lumborum Having Non-Specific Chronic Low Back. 2020;10(December):263-9.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing shockwave machine, leg and back exercises and shockwave and exercises in people with Low Back Pain, Mechanical, run by University of Sharjah.
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 5 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 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 maram makki (+971567288781, mmarram95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pressure-pain threshold (time frame: 45 hour session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05257421, which also lists 3 linked publications.
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 14 Mar 2022.