NCT06593691

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Oct 2024

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

October 9, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

March 5, 2025

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

July 31, 2024

Last Update Submit

March 4, 2025

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • 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'.

    Through study completion, an average of 1 year

Secondary Outcomes (6)

  • Functionality

    Through study completion, an average of 1 year

  • Tactile Acuity

    Through study completion, an average of 1 year

  • Pressure Pain Thereshold

    Through study completion, an average of 1 year

  • Assessment of Quality of life

    Through study completion, an average of 1 year

  • Sleep Quality

    Through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (2)

Conventional treatment group

ACTIVE COMPARATOR

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

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.

Other: conventional treatmentOther: Conventional treatment + multi-wave locked system laser treatment

Interventions

conventional treatmentOTHER

Hot Pack, TENS, therapeutic ultrasound, and exercise

Conventional treatment + Multiwave Locked System Laser treatment groupConventional treatment group
Conventional treatment + multi-wave locked system laser treatmentOTHER

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

Conventional treatment + Multiwave Locked System Laser treatment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Meltem Işıntaş

    Kutahya Health Sciences University

    STUDY DIRECTOR

Central Study Contacts

Meltem Işıntaş

CONTACT

+902742652031meltem.isintas@ksbu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2024

First Posted

September 19, 2024

Study Start

October 9, 2024

Primary Completion

May 1, 2025

Study Completion

August 1, 2026

Last Updated

March 5, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)