Sensorial Discrimination in Chronic Low Back Pain

NCT05169918 | Completed DMC

• 1 other identifier: 242424
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Back Pain; Central Sensitisation

Keywords

Chronic pain; Low back pain; Central sensitisation; Cortical reorganisation; Two point discrimination

Outcome Measures

Primary Outcomes (3)

• Tactile localization

  Tactile localization will be assessed as a clinical sign of cortical reorganisation. The participant will be asked to hold a pencil perpendicular to the surface at the level of the 12th thoracic vertebra in the hand ipsilateral to the tested body side (right hand if the right side of the back has been tested). The researcher will lightly touch one of the predetermined localizations and the participant will be instructed as "Use your pen to touch the point I touched as accurately as possible. Don't slide, lift the pen.". For statistical analysis, the distance between the pre-marked points and the points defined by the participant will be recorded by measuring with the caliper. This procedure will measure three times for each of the six designated points. The reliability of this test has been demonstrated in previous studies.

  Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)

• Two-point discrimination

  Two-point discrimination (TPD) will be assessed as a clinical sign of cortical reorganisation. TPD is a reliable measure for detecting touch accuracy. A digital caliper (Powerfix) will be used for TPD measurements and the participant will not see the caliper during the measurement. With the participant lying prone, the researcher will measure both horizontal and vertical TPD at the L4 level bilaterally. The distance between the tips of the caliper varies between 100 mm and 5 mm, the test will be started at the maximum aperture, The distance will be reduced by 10 mm for each correct detection and increased by 5 mm for each false detection. This process will be repeated three times in descending and ascending order, and the average of the smallest distance between the caliper tips at which the participant can distinguish two separate points will be recorded as the TPD value. This measurement protocol was taken from a previous study.

  Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)

• Pain pressure threshold

  Pain pressure threshold (PPT) will be assessed as a clinical sign of cortical reorganisation. Within the scope of the study, PPT measurement will be made using a digital algometer (Commander Algometer, J-Tech Medical Industries, Salt Lake City, USA). The tests will be applied to the Gluteus medius (middle and posterior part), Gluteus minimus, Gluteus maximus, Piriformis, Quadratus lumborum and Iliopsoas muscles by using a 1 cm2-pointer and increasing the pressure intensity by 1 kg/cm2 every second. The participants will be asked to tell the evaluator the point where the pressure to be applied turns into mild pain, and the average of three tests performed at 30-second intervals will be recorded in kg/cm2.

  Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)

Secondary Outcomes (8)

• Proprioception

  Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)

• Lumbopelvic motor control

  Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)

• Pain intensity

  Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)

• Central Sensitization

  Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)

• Pain catastrophizing

  Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)

Study Arms (2)

Control group

ACTIVE COMPARATOR

Other: Core stabilization

Training Group

EXPERIMENTAL

Other: Core stabilization; Other: Sensorial Discrimination Training

Interventions

Core stabilization 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.

Control group; Training Group

Sensorial Discrimination Training 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.

Training Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• Graham A, Ryan CG, MacSween A, Alexanders J, Livadas N, Oatway S, Atkinson G, Martin DJ. Sensory discrimination training for adults with chronic musculoskeletal pain: a systematic review. Physiother Theory Pract. 2022 Sep;38(9):1107-1125. doi: 10.1080/09593985.2020.1830455. Epub 2020 Oct 20.

  PMID: 33078667 BACKGROUND

• Kalin S, Rausch-Osthoff AK, Bauer CM. What is the effect of sensory discrimination training on chronic low back pain? A systematic review. BMC Musculoskelet Disord. 2016 Apr 2;17:143. doi: 10.1186/s12891-016-0997-8.

  PMID: 27038609 BACKGROUND

• Ehrenbrusthoff K, Ryan CG, Gruneberg C, Martin DJ. A systematic review and meta-analysis of the reliability and validity of sensorimotor measurement instruments in people with chronic low back pain. Musculoskelet Sci Pract. 2018 Jun;35:73-83. doi: 10.1016/j.msksp.2018.02.007. Epub 2018 Mar 2.

  PMID: 29549815 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, PT, MSc, Research Assistant, Principal investigator

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: December 27, 2021
• Study Start: November 15, 2022
• Primary Completion: February 15, 2024
• Study Completion: April 1, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

TU (1)