Myofascial Massage in the Treatment of Chronic Low Back Pain

NCT ID: NCT02646280

Last Updated: 2016-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-01-31

Brief Summary

The purpose of the study is to determine the effectiveness of an approach that combines massage therapy with elements of neurocognitive rehabilitation such as motor imagery and the words of the physiotherapist compared to a traditional massage therapy in reducing pain in patients with chronic low back pain (CLBP) and to evaluate if and how the pain reduction is linked to the interoceptive awareness and which is the patient's ability to relax through the measurement of the hearth rate variability (HRV).

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Massage therapy and contact experience

Traditional massage therapy consisting of different phases: surface touch, deep touch, static pressures, dynamic pressures and kneading associated with a preparation to the contact phase of the massage using the typical elements of neurocognitive rehabilitation such as motor imagery, dynamic state during which a person mentally simulates an action, and language, necessary to understand the way of perceiving and organizing sensory, cognitive and phenomenological informations by the patients and so to interpretate pain in a more articulate way.

Group Type: EXPERIMENTAL

Massage therapy

Intervention Type: OTHER

Massage therapy as a treatment option to induce a relaxation and a reduction of pain and stress in patients affected by chronic low back pain.

Neurocognitive rehabilitation

Intervention Type: OTHER

Provided through the association of motor imagery and the words of the physiotherapist with the aim of increasing the effectiveness of massage in reducing pain.

Massage therapy

Traditional massage therapy consisting of different phases: surface touch, deep touch, static pressures, dynamic pressures and kneading.

Group Type: ACTIVE_COMPARATOR

Massage therapy

Intervention Type: OTHER

Massage therapy as a treatment option to induce a relaxation and a reduction of pain and stress in patients affected by chronic low back pain.

Interventions

Massage therapy

Massage therapy as a treatment option to induce a relaxation and a reduction of pain and stress in patients affected by chronic low back pain.

Intervention Type: OTHER

Neurocognitive rehabilitation

Provided through the association of motor imagery and the words of the physiotherapist with the aim of increasing the effectiveness of massage in reducing pain.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Presence of chronic nonspecific low back pain for at least three months
• Subjects aged between 18 and 50 years

Exclusion Criteria

• Presence of acute low back pain
• Low back pain due to other causes (vertebral fractures, spondylolisthesis, herniated discs, lumbar canal stenosis)
• Disorders of central and/or peripheral nervous system
• Systemic inflammatory disease (eg rheumatoid arthritis)
• Systemic infectious disease
• Neoplastic disease
• Previous Surgery
• Cognitive impairment
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Teresa Paolucci

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincenzo Maria Saraceni

Role: PRINCIPAL_INVESTIGATOR

Umberto I Hospital, University "Sapienza" of Rome

Locations

Umberto I Hospital

Rome, , Italy

Countries

Italy

Other Identifiers

3791/2015

Identifier Type: -

Identifier Source: org_study_id