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

NCT ID: NCT05419310

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-12
• Study Completion Date: 2025-03-30

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.

Conditions

Low Back Pain; Orthopedic Disorder; Physical Therapy; Core Strengthening; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A1

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

Group Type: EXPERIMENTAL

Rehabilitation - core strengthening

Intervention Type: OTHER

Physical rehabilitation based on core strengthening

Elastic taping application

Intervention Type: OTHER

Application of elastic taping

Group A2

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

Group Type: SHAM_COMPARATOR

Rehabilitation - core strengthening

Intervention Type: OTHER

Physical rehabilitation based on core strengthening

Elastic taping application

Intervention Type: OTHER

Application of elastic taping

Group A3

rehabilitation based on exercises for core strengthening

Group Type: EXPERIMENTAL

Rehabilitation - core strengthening

Intervention Type: OTHER

Physical rehabilitation based on core strengthening

Group B

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

Group Type: ACTIVE_COMPARATOR

Rehabilitation - rehabilitation pilates

Intervention Type: OTHER

Physical rehabilitation based on rehabilitation pilates

Interventions

Rehabilitation - core strengthening

Physical rehabilitation based on core strengthening

Intervention Type: OTHER

Rehabilitation - rehabilitation pilates

Physical rehabilitation based on rehabilitation pilates

Intervention Type: OTHER

Elastic taping application

Application of elastic taping

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Marco Bravi

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvia Sterzi, Professor

Role: PRINCIPAL_INVESTIGATOR

Foundation Policlinico Campus Bio-Medico of Rome

Locations

Fondazione Policlinico Campus Biomedico

Roma, RM, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Marco Bravi, Dott

Role: CONTACT

m.bravi@policlinicocampus.it

0622541624 ext. +39

Facility Contacts

Marco Bravi, Dott

Role: primary

m.bravi@policlinicocampus.it

Other Identifiers

26.22

Identifier Type: -

Identifier Source: org_study_id