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

Sponsor

Campus Bio-Medico University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05419310

Collaborator

(none)

120

Enrollment

Location

Arms

34.6

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain Orthopedic Disorder Physical Therapy Core Strengthening Rehabilitation	Other: Rehabilitation - core strengthening Other: Rehabilitation - rehabilitation pilates Other: Elastic taping application	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

May 12, 2022

Anticipated Primary Completion Date :

Mar 30, 2025

Anticipated Study Completion Date :

Mar 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A1 Rehabilitation based on core strengthening exercises associated with the application of REAL elastic taping	Other: Rehabilitation - core strengthening Physical rehabilitation based on core strengthening Other: Elastic taping application Application of elastic taping
Sham Comparator: Group A2 Rehabilitation based on core strengthening exercises, associated with the application of SHAM elastic taping - sham comparator to group A1	Other: Rehabilitation - core strengthening Physical rehabilitation based on core strengthening Other: Elastic taping application Application of elastic taping
Experimental: Group A3 rehabilitation based on exercises for core strengthening	Other: Rehabilitation - core strengthening Physical rehabilitation based on core strengthening
Active Comparator: Group B The intervention group B will perform rehabilitation treatment with a structured protocol based on rehabilitation pilates. Comparator to Group A3	Other: Rehabilitation - rehabilitation pilates Physical rehabilitation based on rehabilitation pilates

Outcome Measures

Primary Outcome Measures

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 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 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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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