Clinical trial NCT05169918: Sensorial Discrimination in Chronic Low Back Pain
Official title: Efficiency of Sensory Discrimination Training in Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Back Pain
Central Sensitisation
Keywords: Chronic pain
Low back pain
Central sensitisation
Cortical reorganisation
Two point discrimination
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-12-27
Enrollment: 27
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Tactile localization
timeFrame: Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)
measure: Two-point discrimination
timeFrame: Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)
measure: Pain pressure threshold
timeFrame: Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)
Secondary outcomes:
measure: Proprioception
timeFrame: Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)
measure: Lumbopelvic motor control
timeFrame: Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)
measure: Pain intensity
timeFrame: Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)
measure: Central Sensitization
timeFrame: Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)
measure: Pain catastrophizing
timeFrame: Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)
measure: Functionality
timeFrame: Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)
measure: Kinesiophobia
timeFrame: Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)
measure: Short Form-12
timeFrame: Baseline, Change from Baseline at 6th week, Change from Baseline at 10th week (end of the treatment)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.