Sensorial Discrimination in Chronic Low Back Pain

Status Recruiting

Clinical Trial Summary

In this study, the effect of sensory discrimination training on cortical reorganization, pain and functionality in chronic nonspecific low back pain in which central sensitization is dominant will be investigated.

Clinical Trial Description

Patients who agree to participate in the study will be assigned to Group I (core stabilization) or Group II (core stabilization+sensorial discrimination training) after being screened and randomized according to the inclusion criteria on day one. On the first day, all evaluations will be carried out by taking informed consent form from the participants. With the participants in Group I, progressive core stabilization exercises will be practiced for 20-30 minutes a day, 2 days a week for 10 weeks. In Group II, sensorial discrimination training will be studied for 20 minutes before core stabilization exercises. Core stabilization exercise will be performed in accompany with a physiotherapist who has a I. Level mat exercises certificate. At the end of each week, participants will be questioned about the use of an adjunctive intervention to treatment, including changes in medication use, or the presence of an unexpected reaction to treatment, and their responses recorded. All assessments will be repeated before treatment, at the end of the 6th week, and at the end of the 10th week. The primary outcome is cortical reorganisation which will be assessed with tactile localization, two point discrimination, pressure pain threshold. Also, proprioception of the lumbal region, lumbopelvic control, pain intensity, functionality, central sensitization, pain catastrophizing, kinesiophobia, and quality of life of the participants will be assessed. Power and Sample Size Program was used to calculate the sample size. Minimal clinically important difference (MCID) and standard deviation (SD) values were used during the calculation. For the Numerical Rating Scale, the MCID value was 4.15 and the Standard Deviation value was 3. It was calculated that a total of 15 participants, 15 participants in both groups, should be included in the study. A total of 36 participants will be included in the study by calculating a 20% probability due to the possibility of the participants being excluded from treatment or dropped out. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05169918
Study type	Interventional
Source	Istanbul University - Cerrahpasa (IUC)
Contact	Aybike Senel, PT, MSc
Phone	+31433885655
Email	Aybikesenel@hotmail.com
Status	Recruiting
Phase	N/A
Start date	November 15, 2022
Completion date	March 1, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.