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

Campus Bio-Medico University of Rome

Status: Enrolling

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

Treatments: Other: Elastic taping application; Other: Rehabilitation - rehabilitation pilates; Other: Rehabilitation - core strengthening

Study type: Interventional

Funder types: Other

Identifiers

NCT05419310

26.22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Group A1

Experimental group

Description:

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

Treatment:

Other: Elastic taping application

Other: Rehabilitation - core strengthening

Group A2

Sham Comparator group

Description:

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

Treatment:

Other: Elastic taping application

Other: Rehabilitation - core strengthening

Group A3

Experimental group

Description:

rehabilitation based on exercises for core strengthening

Treatment:

Other: Rehabilitation - core strengthening

Group B

Active Comparator group

Description:

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

Treatment:

Other: Rehabilitation - rehabilitation pilates