Low Back PainNCT06487338
Effect of Low-level Laser Therapy Versus Shock Wave Therapy on Pain and Function in Patients With Chronic Non-specific Low Back Pain
A study testing Low-level laser therapy and Shock wave Therapy in people with Low Back Pain, run by October 6 University at 1 site in Egypt.
Trial summary
A significant global source of disability is low back pain. Maladaptive variations in the level of activity in the lumbar musculature are one thing that could possibly contribute to persistent pain. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Low-level laser therapy and Shock wave Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2024to 20 Jan 2025
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients will suffer from mechanical low back pain
- Age will range from 20 to 40 years
- All patients will have BMI range from 20-24
Who cannot join
- History of radicular pain
- Lumbar disc prolapse.
- Visual problems
- History of previous lumbar surgery
- BMI more than 24
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low-level Laser Therapy Versus Shock Wave Therapy on Pain and Function in Patients With Chronic Non-specific Low Back Pain: a Randomized Controlled Clinical Trial
A significant global source of disability is low back pain. Maladaptive variations in the level of activity in the lumbar musculature are one thing that could possibly contribute to persistent pain.
- Conditions
- Low Back Pain
- Being tested
- Low-level laser therapy, Shock wave Therapy
- Keywords
- Low-level laser therapy, Shock wave therapy, Pain, Function, Chronic Non-Specific Low Back Pain
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapyOther
Is a form of medicine that applies low-level (low-power) lasers that relieve pain.The effects appear to be limited to a specified set of wavelengths
Shock wave TherapyOther
is a non-invasive treatment that stimulates the body's natural healing process. It can relieve pain and promote healing of injured tendons, ligaments, and other soft tissues
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Twenty patients will receive low-level laser therapy 3 times per week for a month Receives: Other: Low-level laser therapy |
| Group B | Experimental | Twenty patients will receive shock wave therapy 3 times per week for a month Receives: Other: Shock wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry low back disability questionnaire
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome toolsFor each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows: Example: 16 (total scored) 50 (total possible score) x 100 = 32%
If one section is missed or not applicable the score is calculated:
16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum detectable change (90% confidence): 10% points (change of less than this may be attributable to error in the measurement)
Measured: 30 minutes
Back pain functional scale
The Back Pain Functional Scale (BPFS) is a subjective scale used to measure the patient's physical function after low back painThis scale consists of a total score of 60. Moreover, the patient's score can be measured from the responses obtained on the Likert scale (0 to 5), and accordingly, a total score is summed up out of 60. Furthermore, the maximum score obtained indicates the maximum physical abilities of the patients. In addition, this scale also has an 'Adjusted score' ranging from 0 (0%)-unable to perform any activity to 60 (100%)-no difficulty in any activity
Measured: 20 minutes
Visual analogue scale
Visual analogue scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions.
Visual analogue scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end.48 Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start25 Aug 2024
- Primary completion20 Oct 2024
- Study completion20 Jan 2025
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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Magdy Metwally, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487338
- Sponsor's protocol ID
- 2024
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-level Laser Therapy Versus Shock Wave Therapy on Pain and Function in Patients With Chronic Non-specific Low Back Pain: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06487338
- Acronym / sponsor ID
- 2024
- Conditions
- Low Back Pain
- Keywords
- Low-level laser therapy, Shock wave therapy, Pain, Function, Chronic Non-Specific Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 5 Jul 2024 (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.
A significant global source of disability is low back pain. Maladaptive variations in the level of activity in the lumbar musculature are one thing that could possibly contribute to persistent pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Low-level laser therapyTwenty patients will receive low-level laser therapy 3 times per week for a month |
| Group B | Experimental | Other: Shock wave TherapyTwenty patients will receive shock wave therapy 3 times per week for a month |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All patients will suffer from mechanical low back pain
- Age will range from 20 to 40 years
- All patients will have BMI range from 20-24
Key exclusion criteria (5 listed)
- History of radicular pain
- Lumbar disc prolapse.
- Visual problems
- History of previous lumbar surgery
- BMI more than 24
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 |
|---|---|---|
| Low-level laser therapyIs a form of medicine that applies low-level (low-power) lasers that relieve pain.The effects appear to be limited to a specified set of wavelengths | Other | Group A |
| Shock wave Therapyis a non-invasive treatment that stimulates the body's natural healing process. It can relieve pain and promote healing of injured tendons, ligaments, and other soft tissues | Other | Group B |
Primary outcome
Oswestry low back disability questionnaire
Time frame: 30 minutes
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome toolsFor each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows: Example: 16 (total scored) 50 (total possible score) x 100 = 32% If one section is missed or not applicable the score is calculated: 16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum detectable change (90% confidence): 10% points (change of less than this may be attributable to error in the measurement)
Back pain functional scale
Time frame: 20 minutes
The Back Pain Functional Scale (BPFS) is a subjective scale used to measure the patient's physical function after low back painThis scale consists of a total score of 60. Moreover, the patient's score can be measured from the responses obtained on the Likert scale (0 to 5), and accordingly, a total score is summed up out of 60. Furthermore, the maximum score obtained indicates the maximum physical abilities of the patients. In addition, this scale also has an 'Adjusted score' ranging from 0 (0%)-unable to perform any activity to 60 (100%)-no difficulty in any activity
Visual analogue scale
Time frame: 5 minutes
Visual analogue scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. Visual analogue scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end.48 Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level laser therapy and Shock wave Therapy in people with Low Back Pain, run by October 6 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 3 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: finished, as of the sponsor's last update on 26 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry low back disability questionnaire (time frame: 30 minutes). 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?
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 26 Dec 2025.