Low Back PainNCT06593691
Examining the Effectiveness of Multiwave Locked System Laser Treatment in Chronic Low Back Pain
A study testing conventional treatment and Conventional treatment + multi-wave locked system laser treatment in people with Low Back Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Patients who come to Tavşanlı Assoc. Prof. Dr. Mustafa Kalemli State Hospital, Physical Therapy, and Rehabilitation Department who have been diagnosed with Chronic Low Back Pain by a physician will be included. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- conventional treatment and Conventional treatment + multi-wave locked system laser treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Oct 2024to 10 Aug 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65
- Volunteering to participate in the study
- Having low back pain that has persisted for at least 3 months
Who cannot join
- History of surgery in the waist area
- Discopathy at a different level of the spine (Modic Type 3)
- Presence of tumor in the spine
- Infection in the discs
- Having an inflammatory disease
- Presence of neurological involvement
Show all 12Show fewer
- Fracture
- Spondylosis
- Spinal Stenosis
- Spondylolisthesis
- Radiculopathy
- Having received treatment for low back pain in the last 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43100
About this study
Patients who come to Tavşanlı Assoc. Prof. Dr. Mustafa Kalemli State Hospital, Physical Therapy, and Rehabilitation Department who have been diagnosed with Chronic Low Back Pain by a physician will be included. Patients will be divided into two groups by the physician: conservative treatment and patients whose treatment program is determined as multi-wave locked system laser treatment in addition to conservative treatment. Pain intensity will be measured with a numerical pain rating scale. The Roland-Morris disability questionnaire will be used to evaluate the functionality of the participants, and the esthesiometer will be used to assess tactile acuity. Pressure pain threshold will be evaluated with the MicroFET 2 device. The Turkish Form of the SF-12 Quality of Life Scale will be used to assess the participants' quality of life. Pittsburgh's sleep quality index will be used to evaluate sleep quality. Patient satisfaction will be evaluated with a numerical rating scale.
- Conditions
- Low Back Pain
- Being tested
- conventional treatment, Conventional treatment + multi-wave locked system laser treatment
- 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.
conventional treatmentOther
Hot Pack, TENS, therapeutic ultrasound, and exercise
Conventional treatment + multi-wave locked system laser treatmentOther
Hot Pack, TENS, therapeutic ultrasound, and exercise + multi-wave locked system laser treatment
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment group | Active comparator | In conventional treatment, Hot Pack, TENS, therapeutic ultrasound and exercise program will be given by the hospital staff. Receives: Other: conventional treatment |
| Conventional treatment + Multiwave Locked System Laser treatment group | Experimental | Multiwave-locked system laser treatment will be applied by the hospital staff to the group in addition to conventional treatment. Receives: Other: conventional treatment; Other: Conventional treatment + multi-wave locked system laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
Numerical Pain Rating Scale: Ratings from 0 to 10 range from no pain to the highest pain level imaginable. Studies show that a 2-point change in the evaluation made with this scale indicates a clinically significant change beyond the limits of measurement error.Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Functionality
The Roland-Morris Disability Questionnaire: This survey contains 24 questions about the impact of low back pain on a person's functionality. The yes answer given by the people is evaluated as 1 point, the no answer is evaluated as 0 points, and a total score between 0 and 24 is received.The score ranges from 0 (no disability) to 24 (max. disability) depending on the questionnaire used.
Measured: Through study completion, an average of 1 year
Tactile Acuity
Esthesiometer: Measurements will be taken by moving horizontally from the midline where the spinous process of the 3rd lumbar vertebra is located to the dominant part of the person. The evaluation will start from the position where the distance between two points is 0 mm, and the distance will be increased until the person can distinguish between two points. Around this determined threshold, 5 increasing and decreasing evaluations will be made and the average of the evaluation will be taken.
Measured: Through study completion, an average of 1 year
Pressure Pain Thereshold
MicroFET 2: Measurements will be taken 5 centimeters to the right and left of the spinous processes of the 3rd and 5th Lumbal vertebrae, which will be marked before. Two more points (on the tibialis anterior muscle of the right and left legs, 5 centimeters lateral to the tuberosity tibia) will be marked and used for control. The probe will be applied perpendicular to the skin, and the pressure will be gradually increased, starting from the point where no pressure is applied at first. At the point when the feeling of pressure turns into pain, participants will be instructed to call this point. This value will be recorded during the application, and after waiting the required time, additional measurements will be taken to calculate the pressure pain threshold.
Measured: Through study completion, an average of 1 year
Assessment of Quality of life
SF 12: The SF-12 health survey is a self-reported outcome measure designed for use among the general population. It is a 12-item short-form health survey that assesses the same eight health domains as the SF-36 Health Survey. Each health domain score contributes to the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Measured: Through study completion, an average of 1 year
Sleep Quality
Pittsburgh Sleep Quality Index: 19 out of 24 questions are self-answered questions. While other questions include questions to get information from a roommate or bed partner, some questions in the index are included in the scoring. There are 7 components and the total score varies between 0 and 21. If the total PSQI score is below 5, sleep quality is considered good, and if it is above 5, sleep quality is considered poor.
Measured: Through study completion, an average of 1 year
Patient Satisfaction
Numerical Rating Scale: Participants will score their satisfaction between 0 and 10, with higher scores indicating a higher level of satisfaction.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Oct 2024
- Primary completion9 Dec 2025
- Study completion10 Aug 2026
Why it stopped: Terminated due to PhD student dismissal. Institutional review board (IRB) approval remains active for potential resumption with new staff.
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.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meltem Işıntaş, Study director, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593691
- Sponsor's protocol ID
- 2024/09-36
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of Multiwave Locked System Laser Treatment in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06593691
- Acronym / sponsor ID
- 2024/09-36
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated due to PhD student dismissal. Institutional review board (IRB) approval remains active for potential resumption with new staff.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 19 Sep 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.
Patients who come to Tavşanlı Assoc. Prof. Dr. Mustafa Kalemli State Hospital, Physical Therapy, and Rehabilitation Department who have been diagnosed with Chronic Low Back Pain by a physician will be included. Patients will be divided into two groups by the physician: conservative treatment and patients whose treatment program is determined as multi-wave locked system laser treatment in addition to conservative treatment. Pain intensity will be measured with a numerical pain rating scale. The Roland-Morris disability questionnaire will be used to evaluate the functionality of the participants, and the esthesiometer will be used to assess tactile acuity. Pressure pain threshold will be evaluated with the MicroFET 2 device. The Turkish Form of the SF-12 Quality of Life Scale will be used to assess the participants' quality of life. Pittsburgh's sleep quality index will be used to evaluate sleep quality. Patient satisfaction will be evaluated with a numerical rating scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment group | Active comparator | Other: conventional treatmentIn conventional treatment, Hot Pack, TENS, therapeutic ultrasound and exercise program will be given by the hospital staff. |
| Conventional treatment + Multiwave Locked System Laser treatment group | Experimental | Other: conventional treatment, Other: Conventional treatment + multi-wave locked system laser treatmentMultiwave-locked system laser treatment will be applied by the hospital staff to the group in addition to conventional treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-65
- Volunteering to participate in the study
- Having low back pain that has persisted for at least 3 months
Key exclusion criteria (12 listed)
- History of surgery in the waist area
- Discopathy at a different level of the spine (Modic Type 3)
- Presence of tumor in the spine
- Infection in the discs
- Having an inflammatory disease
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 |
|---|---|---|
| conventional treatmentHot Pack, TENS, therapeutic ultrasound, and exercise | Other | Conventional treatment + Multiwave Locked System Laser treatment group, Conventional treatment group |
| Conventional treatment + multi-wave locked system laser treatmentHot Pack, TENS, therapeutic ultrasound, and exercise + multi-wave locked system laser treatment | Other | Conventional treatment + Multiwave Locked System Laser treatment group |
Primary outcome
pain intensity
Time frame: Through study completion, an average of 1 year
Numerical Pain Rating Scale: Ratings from 0 to 10 range from no pain to the highest pain level imaginable. Studies show that a 2-point change in the evaluation made with this scale indicates a clinically significant change beyond the limits of measurement error.Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
6 secondary outcomes
Functionality
Time frame: Through study completion, an average of 1 year
Tactile Acuity
Time frame: Through study completion, an average of 1 year
Pressure Pain Thereshold
Time frame: Through study completion, an average of 1 year
Assessment of Quality of life
Time frame: Through study completion, an average of 1 year
Sleep Quality
Time frame: Through study completion, an average of 1 year
Patient Satisfaction
Time frame: Through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Meltem Işıntaş study director
Kutahya Health Sciences 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 conventional treatment and Conventional treatment + multi-wave locked system laser treatment in people with Low Back Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 12 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: withdrawn, as of the sponsor's last update on 12 Aug 2026. 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 Turkey (Türkiye). 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 was withdrawn before enrolling participants, so there are no results.
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?
pain intensity (time frame: Through study completion, an average of 1 year). 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 12 Aug 2026.