Evaluation on the Effects of Two Rehabilitation Treatment and Tape for Functional and Motor Recovery of LBP Patients
LBPT001
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.
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started May 2022
Longer than P75 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 12, 2022
CompletedFirst Submitted
Initial submission to the registry
June 7, 2022
CompletedFirst Posted
Study publicly available on registry
June 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2025
CompletedApril 6, 2023
April 1, 2023
2.9 years
June 7, 2022
April 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
changes in the low back pain related quality of life
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)
Study Arms (4)
Group A1
EXPERIMENTALRehabilitation based on core strengthening exercises associated with the application of REAL elastic taping
Group A2
SHAM COMPARATORRehabilitation based on core strengthening exercises, associated with the application of SHAM elastic taping - sham comparator to group A1
Group A3
EXPERIMENTALrehabilitation based on exercises for core strengthening
Group B
ACTIVE COMPARATORThe intervention group B will perform rehabilitation treatment with a structured protocol based on rehabilitation pilates. Comparator to Group A3
Interventions
Physical rehabilitation based on core strengthening
Physical rehabilitation based on rehabilitation pilates
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Policlinico Campus Biomedico
Roma, RM, 00128, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Silvia Sterzi, Professor
Foundation Policlinico Campus Bio-Medico of Rome
Central Study Contacts
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
- Physiotherapist
Study Record Dates
First Submitted
June 7, 2022
First Posted
June 15, 2022
Study Start
May 12, 2022
Primary Completion
March 30, 2025
Study Completion
March 30, 2025
Last Updated
April 6, 2023
Record last verified: 2023-04