Low Back PainLBPT001NCT05419310
Evaluation on the Effects of Two Rehabilitation Treatment and Tape for Functional and Motor Recovery of LBP Patients
A study testing Rehabilitation - core strengthening, Rehabilitation - rehabilitation pilates and Elastic taping application in people with Low Back Pain and Orthopedic Disorder, run by Campus Bio-Medico University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Orthopedic Disorder, Physical Therapy
- What is being tested?
- Rehabilitation - core strengthening, Rehabilitation - rehabilitation pilates and Elastic taping application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 12 May 2022to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Campus Biomedico
Roma, RM, 00128
Marco Bravi, Dott, m.bravi@policlinicocampus.it
About this study
Official title: 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.
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.
Read the detailed description
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.
- Being tested
- Rehabilitation - core strengthening, Rehabilitation - rehabilitation pilates, Elastic taping application
- Keywords
- Low Back Tape, Tape, Kinesio Tape, Core Strengthening, Pilates Rehabilitation, Physical Therapy, Athletic Tape
- Medical subject headings
- Low Back Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation - core strengtheningOther
Physical rehabilitation based on core strengthening
Rehabilitation - rehabilitation pilatesOther
Physical rehabilitation based on rehabilitation pilates
Elastic taping applicationOther
Application of elastic taping
| Study group | Role | What they receive |
|---|---|---|
| Group A1 | Experimental | Rehabilitation based on core strengthening exercises associated with the application of REAL elastic taping Receives: Other: Rehabilitation - core strengthening; Other: Elastic taping application |
| Group A2 | Sham comparator | Rehabilitation based on core strengthening exercises, associated with the application of SHAM elastic taping - sham comparator to group A1 Receives: Other: Rehabilitation - core strengthening; Other: Elastic taping application |
| Group A3 | Experimental | rehabilitation based on exercises for core strengthening Receives: Other: Rehabilitation - 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 Receives: Other: Rehabilitation - rehabilitation pilates |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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
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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start12 May 2022
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Bravi, Campus Bio-Medico University
- Investigators
- Silvia Sterzi, Professor, Principal investigator, Foundation Policlinico Campus Bio-Medico of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419310
- Sponsor's protocol ID
- 26.22
- Acronym
- LBPT001
- Status last verified
- Apr 2023
- First submitted
- 7 Jun 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05419310
- Acronym / sponsor ID
- LBPT001 / 26.22
- Keywords
- Low Back Tape, Tape, Kinesio Tape, Core Strengthening, Pilates Rehabilitation, Physical Therapy, Athletic Tape
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A1 | Experimental | Other: Rehabilitation - core strengthening, Other: Elastic taping applicationRehabilitation based on core strengthening exercises associated with the application of REAL elastic taping |
| Group A2 | Sham comparator | Other: Rehabilitation - core strengthening, Other: Elastic taping applicationRehabilitation based on core strengthening exercises, associated with the application of SHAM elastic taping - sham comparator to group A1 |
| Group A3 | Experimental | Other: Rehabilitation - core strengtheningrehabilitation based on exercises for core strengthening |
| Group B | Active comparator | Other: Rehabilitation - rehabilitation pilatesThe intervention group B will perform rehabilitation treatment with a structured protocol based on rehabilitation pilates. Comparator to Group A3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation - core strengtheningPhysical rehabilitation based on core strengthening | Other | Group A1, Group A2, Group A3 |
| Rehabilitation - rehabilitation pilatesPhysical rehabilitation based on rehabilitation pilates | Other | Group B |
| Elastic taping applicationApplication of elastic taping | Other | Group A1, Group A2 |
Primary outcome
changes in the low back pain related disability
Time frame: 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 from baseline of the low back pain disability will be assessed through the use of the Roland and Morris Disability Questionnaire
changes in the low back pain intensity and perception
Time frame: 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 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)
changes in the low back pain related anxiety and depression
Time frame: 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 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)
changes in the spine kinematics
Time frame: 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 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.
1 secondary outcome
changes in the low back pain related quality of life
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Sterzi, Professor principal investigator
Foundation Policlinico Campus Bio-Medico of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation - core strengthening, Rehabilitation - rehabilitation pilates and Elastic taping application in people with Low Back Pain and Orthopedic Disorder, run by Campus Bio-Medico University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Bravi, Dott (0622541624 ext. +39, m.bravi@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in the low back pain related disability (time frame: 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.