Sensorial Discrimination in Chronic Low Back Pain

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

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2024-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Pain Back Pain Central Sensitisation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Group Type ACTIVE_COMPARATOR

Core stabilization

Intervention Type OTHER

The progressive core stabilization exercise approach created by Kumar et al. will be used.

* Stage 1; Isolation and facilitation of target muscles
* Stage 2; Trunk stabilization training with increased load under static conditions
* Stage 3; Development of trunk stabilization during slow controlled movement of the lumbar spine.
* Stage 4 and 5; Lumbar stabilization during high speed and dexterous movements. The exercises will last 20-30 minutes in each sessions and twice a week for 10 weeks. The level of stage will be increased when the patients reach the aim of the stage where he/she is at. The duration of the each stage will change depending on the days the patients' need to achieve the aim of the level. For each level, at least four exercise is described.

Training Group

Group Type EXPERIMENTAL

Core stabilization

Intervention Type OTHER

The progressive core stabilization exercise approach created by Kumar et al. will be used.

* Stage 1; Isolation and facilitation of target muscles
* Stage 2; Trunk stabilization training with increased load under static conditions
* Stage 3; Development of trunk stabilization during slow controlled movement of the lumbar spine.
* Stage 4 and 5; Lumbar stabilization during high speed and dexterous movements. The exercises will last 20-30 minutes in each sessions and twice a week for 10 weeks. The level of stage will be increased when the patients reach the aim of the stage where he/she is at. The duration of the each stage will change depending on the days the patients' need to achieve the aim of the level. For each level, at least four exercise is described.

Sensorial Discrimination Training

Intervention Type OTHER

Training group will be participate in core stabilization exercises (as describe in Control Group). Additionally, Sensorial Discrimination Training (SDT) will be applied on the low back of the patients for 20 minutes before the 20 minutes of core stabilization exercises. SDT is defined as the ability to correctly interpret the characteristics of the stimulus made to a part of the body by the patient. It aims to reverse the cortical reorganization observed in patients with chronic pain. It consists of tactile localization and graphesthesia training, which includes determining the localization and type of stimulus and recognizing the letter/number that drawn in a body part, by the patient. The training consists of five stages progressively, each stage lasting two weeks. As the participants complete the sensory tests at each stage with 90% accuracy, the next stage will be passed. If this accuracy rate is not achieved within two weeks, the stage can be extended for one week.

Interventions

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Core stabilization

The progressive core stabilization exercise approach created by Kumar et al. will be used.

* Stage 1; Isolation and facilitation of target muscles
* Stage 2; Trunk stabilization training with increased load under static conditions
* Stage 3; Development of trunk stabilization during slow controlled movement of the lumbar spine.
* Stage 4 and 5; Lumbar stabilization during high speed and dexterous movements. The exercises will last 20-30 minutes in each sessions and twice a week for 10 weeks. The level of stage will be increased when the patients reach the aim of the stage where he/she is at. The duration of the each stage will change depending on the days the patients' need to achieve the aim of the level. For each level, at least four exercise is described.

Intervention Type OTHER

Sensorial Discrimination Training

Training group will be participate in core stabilization exercises (as describe in Control Group). Additionally, Sensorial Discrimination Training (SDT) will be applied on the low back of the patients for 20 minutes before the 20 minutes of core stabilization exercises. SDT is defined as the ability to correctly interpret the characteristics of the stimulus made to a part of the body by the patient. It aims to reverse the cortical reorganization observed in patients with chronic pain. It consists of tactile localization and graphesthesia training, which includes determining the localization and type of stimulus and recognizing the letter/number that drawn in a body part, by the patient. The training consists of five stages progressively, each stage lasting two weeks. As the participants complete the sensory tests at each stage with 90% accuracy, the next stage will be passed. If this accuracy rate is not achieved within two weeks, the stage can be extended for one week.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* To be between 30 and 60 years old
* To have pain lasting longer than 3 months
* To have pain intensity greater than 4 out of 10
* To have pain that is not compatible with anatomical structures and is widespread
* To get score of 40 or more from the Central Sensitization Inventory

Exclusion Criteria

* Inability to perceive the sense of touch in the waist
* Being pregnant
* Using a pacemaker or being diagnosed with heart disease
* Having an open wound in the waist
* Using drugs that affect the central system (dopamine, etc.)
* Having a history of surgery related to the spine
* Presence of a neurological injury or disease
* Having a Body Mass Index of 30 or more
* To have a diagnosis of fibromyalgia

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No