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Evaluation on the Effects of Two Rehabilitation Treatment and Tape for Functional and Motor Recovery of LBP Patients (LBPT001)

Primary Purpose

Low Back Pain, Orthopedic Disorder, Physical Therapy

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Rehabilitation - core strengthening
Rehabilitation - rehabilitation pilates
Elastic taping application
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Tape, Tape, Kinesio Tape, Core Strengthening, Pilates Rehabilitation, Physical Therapy, Athletic Tape

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione Policlinico Campus BiomedicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Active Comparator

Arm Label

Group A1

Group A2

Group A3

Group B

Arm Description

Rehabilitation based on core strengthening exercises associated with the application of REAL elastic taping

Rehabilitation based on core strengthening exercises, associated with the application of SHAM elastic taping - sham comparator to group A1

rehabilitation based on exercises for core strengthening

The intervention group B will perform rehabilitation treatment with a structured protocol based on rehabilitation pilates. Comparator to Group A3

Outcomes

Primary Outcome Measures

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
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)
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)
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.

Secondary Outcome Measures

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)

Full Information

First Posted
June 7, 2022
Last Updated
April 5, 2023
Sponsor
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT05419310
Brief Title
Evaluation on the Effects of Two Rehabilitation Treatment and Tape for Functional and Motor Recovery of LBP Patients
Acronym
LBPT001
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Orthopedic Disorder, Physical Therapy, Core Strengthening, Rehabilitation
Keywords
Low Back Tape, Tape, Kinesio Tape, Core Strengthening, Pilates Rehabilitation, Physical Therapy, Athletic Tape

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A1
Arm Type
Experimental
Arm Description
Rehabilitation based on core strengthening exercises associated with the application of REAL elastic taping
Arm Title
Group A2
Arm Type
Sham Comparator
Arm Description
Rehabilitation based on core strengthening exercises, associated with the application of SHAM elastic taping - sham comparator to group A1
Arm Title
Group A3
Arm Type
Experimental
Arm Description
rehabilitation based on exercises for core strengthening
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
The intervention group B will perform rehabilitation treatment with a structured protocol based on rehabilitation pilates. Comparator to Group A3
Intervention Type
Other
Intervention Name(s)
Rehabilitation - core strengthening
Intervention Description
Physical rehabilitation based on core strengthening
Intervention Type
Other
Intervention Name(s)
Rehabilitation - rehabilitation pilates
Intervention Description
Physical rehabilitation based on rehabilitation pilates
Intervention Type
Other
Intervention Name(s)
Elastic taping application
Intervention Description
Application of elastic taping
Primary Outcome Measure Information:
Title
changes in the low back pain related disability
Description
changes from baseline of the low back pain disability will be assessed through the use of the Roland and Morris Disability Questionnaire
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)
Title
changes in the low back pain intensity and perception
Description
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)
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)
Title
changes in the low back pain related anxiety and depression
Description
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)
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)
Title
changes in the spine kinematics
Description
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.
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)
Secondary Outcome Measure Information:
Title
changes in the low back pain related quality of life
Description
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)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Bravi, Dott
Phone
0622541624
Ext
+39
Email
m.bravi@policlinicocampus.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Sterzi, Professor
Organizational Affiliation
Foundation Policlinico Campus Bio-Medico of Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico Campus Biomedico
City
Roma
State/Province
RM
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Bravi, Dott
Email
m.bravi@policlinicocampus.it

12. IPD Sharing Statement

Learn more about this trial

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

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