Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for Unspecific Low Back Pain

Low Back Pain Clinical Trial

Official title:

Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for Patients With Unspecific Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409562
• Other study ID #: CI 17/108
• Secondary ID: 18/068-E
• Status: Completed
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: June 9, 2021

Study information

• Verified date: June 2022
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the present study is to evaluate whether the addition of two pain neurophysiology education sessions to motor control training may result in an improvement of the outcome measures of pain and disability, compared to motor control training alone.

Description:

Sixty-two subjects with unspecific low-back pain were randomly recruited for the present study. The subjects were randomly allocated to a control group (which received only motor control training) and an intervention group (which underwent two pain neurophysiology education sessions prior to motor control training). Primary outcome measures were pain (measured with the Visual Analogical Scale) and disability (measured with the Oswestry Disability Index). Secondary outcome measures are kinesiophobia (Tampa Scale for Kinesiophobia), the global perceived effect (Global Perceived Effect Scale) and quality of life (SF-12). These will be measured before the intervention, at the end of the intervention, and 3 and 6 months after ending the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 9, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Unspecific low back pain for at least 3 months

• Patients must be knowledgeable in the language in which the educational sessions will be provided (Spanish)

Exclusion Criteria:

• Specific low back pain (e.g. infection, tumor, fracture, radiculopathy).

• Signs and symptoms of neuropathic pain or generalized chronic pain.

• History of lumbar or cervical spine surgery.

• Pregnancy.

• Concomitant pathologies that impede the performance of exercises.

• Psychiatric treatment.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• motor control training
Exercises to strengthen the lumbar musculature and control the posture.
• pain neurophysiology education
Educational sessions to improve patient's neurophysiology of pain knowledge.

Locations

Country	Name	City	State
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid
Spain	Hospital Clínico San Carlos	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS, Hospital Universitario Fundación Alcorcón

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain at different time points	Visual Analogic Scale	Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention
Primary	Change in disability at different time points	Oswestry Disability Index	Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention
Secondary	Change in kinesiophobia at different time points	Tampa Scale of Kinesiophobia	Assessed before the intervention, at the end of the 4-week intervention and 3 and 6 months after the end of the intervention
Secondary	Change in Global Perceived Effect at different time points	Global Perceived Effect Scale	Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention
Secondary	Change in quality of life at different time points	SF-12 questionnaire	Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention