NCT02646280

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

3 months

First QC Date

January 3, 2016

Last Update Submit

May 17, 2016

Conditions

Chronic Low Back Pain

Keywords

Low back paininteroceptive awarenessmotor imagerymassage

Outcome Measures

Primary Outcomes (1)

  • Change of Visual Analogue Scale (VAS) from baseline to 12 weeks

    It is a scale for the assessment of pain and it's based on a ten point scale, where 0 means no pain and 10 the greatest pain ever both at rest and during movements.

    baseline, 4 weeks, 12 weeks

Secondary Outcomes (5)

  • Change of McGill Pain Questionnaire from baseline to 12 weeks

    baseline, 4 weeks, 12 weeks

  • Change of Multidimensional Assessment of Interoceptive Awareness (MAIA) from baseline to 12 weeks

    baseline, 4 weeks, 12 weeks

  • Change of SF-12 Health Survey Questionnaire from baseline to 12 weeks

    baseline, 4 weeks, 12 weeks

  • Change of Waddell Disability Index from baseline to 12 weeks

    baseline, 4 weeks, 12 weeks

  • Change of hearth rate variability (HRV) expressed as coherent ratio from baseline to 4 weeks

    baseline, 4 weeks

Study Arms (2)

Massage therapy and contact experience

EXPERIMENTAL

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.

Other: Massage therapyOther: Neurocognitive rehabilitation

Massage therapy

ACTIVE COMPARATOR

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

Other: Massage therapy

Interventions

Massage therapyOTHER

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.

Massage therapyMassage therapy and contact experience
Neurocognitive rehabilitationOTHER

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 and contact experience

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umberto I Hospital

Rome, 00165, Italy

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Vincenzo Maria Saraceni

    Umberto I Hospital, University "Sapienza" of Rome

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

January 3, 2016

First Posted

January 5, 2016

Study Start

July 1, 2015

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

IT(1)