Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A1 | Experimental | Rehabilitation based on core strengthening exercises associated with the application of REAL elastic taping |
|
| Group A2 | Sham Comparator | Rehabilitation based on core strengthening exercises, associated with the application of SHAM elastic taping - sham comparator to group A1 |
|
| Group A3 | Experimental | rehabilitation based on exercises for core strengthening |
|
| Group B | Active Comparator | The intervention group B will perform rehabilitation treatment with a structured protocol based on rehabilitation pilates. Comparator to Group A3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation - core strengthening | Other | Physical rehabilitation based on core strengthening |
|
| 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) |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Bravi, Dott | Contact | 0622541624 | +39 | m.bravi@policlinicocampus.it |
| Name | Affiliation | Role |
|---|---|---|
| Silvia Sterzi, Professor | Foundation Policlinico Campus Bio-Medico of Rome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Campus Biomedico | Recruiting | Roma | RM | 00128 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rehabilitation - rehabilitation pilates | Other | Physical rehabilitation based on rehabilitation pilates |
|
| Elastic taping application | Other | Application of elastic taping |
|
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided