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

Not Applicable

Recruiting

• Conditions: Low Back Pain; Rehabilitation; Orthopedic Disorder; Physical Therapy; Core Strengthening
• Interventions: Other: Rehabilitation - core strengthening; Other: Rehabilitation - rehabilitation pilates; Other: Elastic taping application

• Registration Number: NCT05419310
• Lead Sponsor: Campus Bio-Medico University

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.

Study Timeline

• Study Start: 2022-05-12
• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-10
• Study First Posted: 2022-06-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A2	Elastic taping application	Rehabilitation based on core strengthening exercises, associated with the application of SHAM elastic taping - sham comparator to group A1
Group A1	Rehabilitation - core strengthening	Rehabilitation based on core strengthening exercises associated with the application of REAL elastic taping
Group A3	Rehabilitation - core strengthening	rehabilitation based on exercises for core strengthening
Group A2	Rehabilitation - core strengthening	Rehabilitation based on core strengthening exercises, associated with the application of SHAM elastic taping - sham comparator to group A1
Group A1	Elastic taping application	Rehabilitation based on core strengthening exercises associated with the application of REAL elastic taping
Group B	Rehabilitation - rehabilitation pilates	The intervention group B will perform rehabilitation treatment with a structured protocol based on rehabilitation pilates. Comparator to Group A3

Primary Outcome Measures

Name	Time	Method
changes in the low back pain related anxiety and depression	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 low back pain related disability	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	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 spine kinematics	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.

Secondary Outcome Measures

Name	Time	Method
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)	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)

Trial Locations

Locations (1)

Fondazione Policlinico Campus Biomedico; 🇮🇹 Roma, RM, Italy