Evaluation on the Effects of Two Rehabilitation Treatment and Tape for Functional and Motor Recovery of LBP Patients

Study Overview
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Brief Summary
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The objective of this study is to verify which is the most effective type of rehabilitation treatment (rehabilitation based on core strengthening vs pilates) in patients suffering from low back pain. The secondary objective is to verify whether the use of Kinesio Tape (KT) associated with rehabilitation treatment can have greater effects in the motor and functional recovery of patients suffering from Low Back Pain than traditional rehabilitation.

Detailed Description
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Patients will undergo an initial assessment with the Physical Medicine and Rehabilitation Unit Physicians, during which the participants will sign the informed consent. After that a first evaluation will be carried out (T-1) during which the subjects will be asked to perform 10 consecutive sit-to-stand tests and 10 consecutive front bending tests. During the sit-to-stand and front bending tests, the kinematics of the spine will be recorded using two MIMU - XSENS DOT. The following scales will also be administered: Roland and Morris Disability Questionnaire Numerical Rating Scales (NRS) 11-point scale to assess the average intensity of pain during the last week The Short Form Health Survey 36 (SF-36) questionnaire to assess quality of life The Modified Somatic Perception Questionnaire (MSPQ) to assess pain somatization The Hospital Anxiety and Depression Scale (HADS) scale to assess anxiety and depression The Pain Catastrophizing Scale (PSC) to assess the catastrophization of pain The Pain Self-Efficacy Questionnaire (PSEQ) for multidimensional pain assessment The Fear Avoidance Beliefs Questionnaire (FABQ) to assess pain avoidance beliefs Patients will be randomized in 2 groups (Group A and Group B). For both groups there will be 12 treatment sessions, 3 times a week. (4 weeks) At mid-treatment (after 2 weeks), at the end of treatment (T1), and in follow-ups following 1 month (T2), 3 months (T3), 6 months (T4) and 12 months (T5) the same assessments of the first visit will be repeated.

Official Title
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Evaluation the Effectiveness of Two Modes of Rehabilitation Treatment and Elastic Taping for the Functional and Motor Recovery of the Patient Suffering From Low Back Pain.

Conditions
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Low Back Pain, Orthopedic Disorder, Physical Therapy, Core Strengthening, Rehabilitation

Intervention / Treatment
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* Other: Rehabilitation - core strengthening
* Other: Rehabilitation - rehabilitation pilates
* Other: Elastic taping application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Signing of informed consent Chronic low back pain defined as non-specific self-reported low back pain that persists daily for at least 3 months or at least half of the days in the last 6 months. Exclusion Criteria: Specific cause of low back pain: disc herniation, spinal stenosis, cauda equina syndrome, infection, fracture, tumor. Pregnant women Neurological disorders and neurological signs (e.g. CNS disorders, weakness, paresthesia) Respiratory disorders Previous spinal surgery. Pain in the lower limbs or lesions limiting their function Taking pain medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A1<br>Rehabilitation based on core strengthening exercises associated with the application of REAL elastic taping | Other: Rehabilitation - core strengthening<br>* Physical rehabilitation based on core strengthening<br>Other: Elastic taping application<br>* Application of elastic taping<br>|
| Sham Comparator: Group A2<br>Rehabilitation based on core strengthening exercises, associated with the application of SHAM elastic taping - sham comparator to group A1 | Other: Rehabilitation - core strengthening<br>* Physical rehabilitation based on core strengthening<br>Other: Elastic taping application<br>* Application of elastic taping<br>|
| Experimental: Group A3<br>rehabilitation based on exercises for core strengthening | Other: Rehabilitation - core strengthening<br>* Physical rehabilitation based on core strengthening<br>|
| Active Comparator: Group B<br>The intervention group B will perform rehabilitation treatment with a structured protocol based on rehabilitation pilates. Comparator to Group A3 | Other: Rehabilitation - rehabilitation pilates<br>* Physical rehabilitation based on rehabilitation pilates<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the low back pain related disability | changes from baseline of the low back pain disability will be assessed through the use of the Roland and Morris Disability Questionnaire | At mid-treatment (2 weeks), at the end of treatment (4 weeks -T1), and in follow-ups following 1 month (T2), 3 months (T3), 6 months (T4) and 12 months (T5) | 
| changes in the low back pain intensity and perception | changes from baseline of the intensity of low back pain will be assessed through the use of the Numerical Rating Scale (NRS), the Modified Somatic Perception Questionnaire (MSPQ), the Pain Catastrophizing Scale (PCS), the Pain Self-Efficacy Questionnaire (PSEQ) and the Fear Avoidance Beliefs Questionnaire (FABQ) | At mid-treatment (2 weeks), at the end of treatment (4 weeks -T1), and in follow-ups following 1 month (T2), 3 months (T3), 6 months (T4) and 12 months (T5) | 
| changes in the low back pain related anxiety and depression | changes from baseline of the low back pain related anxiety and depression will be assessed through the use of the Hospital Anxiety and Depression Scale (HADS) | At mid-treatment (2 weeks), at the end of treatment (4 weeks -T1), and in follow-ups following 1 month (T2), 3 months (T3), 6 months (T4) and 12 months (T5) | 
| changes in the spine kinematics | changes from baseline of the low back pain kinematic will be assessed through the use of two MIMU - XSENS DOT. Subjects will be asked to perform 10 consecutive sit-to-stand tests and 10 consecutive front bending tests. During the tests, the kinematics of the spine will be recorded. | At mid-treatment (2 weeks), at the end of treatment (4 weeks -T1), and in follow-ups following 1 month (T2), 3 months (T3), 6 months (T4) and 12 months (T5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the low back pain related quality of life | changes from baseline of the low back pain related quality of life will be assessed through the use of the Short Form ealthSurvey 36 (SF-36) | At mid-treatment (2 weeks), at the end of treatment (4 weeks -T1), and in follow-ups following 1 month (T2), 3 months (T3), 6 months (T4) and 12 months (T5) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Core Strengthening, Pilates Rehabilitation, Physical Therapy, Athletic Tape, Low Back Tape, Tape, Kinesio Tape