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

Low Back Pain Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05419310
• Other study ID #: 26.22
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2022
• Est. completion date: March 30, 2025

Study information

• Verified date: April 2023
• Source: Campus Bio-Medico University
• Contact: Marco Bravi, Dott
• Phone: 0622541624
• Email: m.bravi[@]policlinicocampus.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Core Strengthening
• Low Back Pain
• Musculoskeletal Diseases
• Orthopedic Disorder
• Physical Therapy
• Rehabilitation

Intervention

Other:
• Rehabilitation - core strengthening
Physical rehabilitation based on core strengthening
• Rehabilitation - rehabilitation pilates
Physical rehabilitation based on rehabilitation pilates
• Elastic taping application
Application of elastic taping

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Campus Biomedico	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Primary	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)	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)
Primary	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)	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)
Primary	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.	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	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)	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)