Clinical trial NCT05419310: Evaluation on the Effects of Two Rehabilitation Treatment and Tape for Functional and Motor Recovery of LBP Patients
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Orthopedic Disorder
Physical Therapy
Core Strengthening
Rehabilitation
Keywords: Low Back Tape
Tape
Kinesio Tape
Core Strengthening
Pilates Rehabilitation
Physical Therapy
Athletic Tape
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: changes in the low back pain related disability
timeFrame: 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)
measure: changes in the low back pain intensity and perception
timeFrame: 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)
measure: changes in the low back pain related anxiety and depression
timeFrame: 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)
measure: changes in the spine kinematics
timeFrame: 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 outcomes:
measure: changes in the low back pain related quality of life
timeFrame: 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)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Campus Biomedico
state: RM
Study officials:
affiliation: Foundation Policlinico Campus Bio-Medico of Rome
name: Silvia Sterzi, Professor
role: PRINCIPAL_INVESTIGATOR
References: