NCT05419310

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Campus Bio-Medico University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Rehabilitation - core strengthening	Physical rehabilitation based on core strengthening
OTHER	Rehabilitation - rehabilitation pilates	Physical rehabilitation based on rehabilitation pilates
OTHER	Elastic taping application	Application of elastic taping

Timeline

• Start date: 2022-05-12
• Primary completion: 2025-03-30
• Completion: 2025-03-30
• First posted: 2022-06-15
• Last updated: 2023-04-06

Locations

1 site across 1 country: Italy