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

  • STATUS
    Recruiting
  • End date
    Mar 30, 2025
  • participants needed
    120
  • sponsor
    Campus Bio-Medico University
Updated on 2 July 2022
back pain
low back pain

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.

Details
Condition Low Back Pain, Orthopedic Disorder, Physical Therapy, Core Strengthening, Rehabilitation
Treatment Rehabilitation - core strengthening, Rehabilitation - rehabilitation pilates, Elastic taping application
Clinical Study IdentifierNCT05419310
SponsorCampus Bio-Medico University
Last Modified on2 July 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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