Examining the Effectiveness of Multiwave Locked System Laser Treatment in Chronic Low Back Pain

NCT ID: NCT06593691

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-09

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional treatment group

In conventional treatment, Hot Pack, TENS, therapeutic ultrasound and exercise program will be given by the hospital staff.

Group Type ACTIVE_COMPARATOR

conventional treatment

Intervention Type OTHER

Hot Pack, TENS, therapeutic ultrasound, and exercise

Conventional treatment + Multiwave Locked System Laser treatment group

Multiwave-locked system laser treatment will be applied by the hospital staff to the group in addition to conventional treatment.

Group Type EXPERIMENTAL

conventional treatment

Intervention Type OTHER

Hot Pack, TENS, therapeutic ultrasound, and exercise

Conventional treatment + multi-wave locked system laser treatment

Intervention Type OTHER

Hot Pack, TENS, therapeutic ultrasound, and exercise + multi-wave locked system laser treatment

Interventions

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conventional treatment

Hot Pack, TENS, therapeutic ultrasound, and exercise

Intervention Type OTHER

Conventional treatment + multi-wave locked system laser treatment

Hot Pack, TENS, therapeutic ultrasound, and exercise + multi-wave locked system laser treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Fracture
* Spondylosis
* Spinal Stenosis
* Spondylolisthesis
* Radiculopathy
* Having received treatment for low back pain in the last 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kutahya Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meltem Işıntaş

Role: STUDY_DIRECTOR

Kutahya Health Sciences University

Locations

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Kutahya Health Sciences University

Kütahya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Meltem Işıntaş

Role: CONTACT

+902742652031

Facility Contacts

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Meltem Isintas

Role: primary

02742652031

Other Identifiers

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2024/09-36

Identifier Type: -

Identifier Source: org_study_id

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