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Myofascial Massage in the Treatment of Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Massage therapy
Neurocognitive rehabilitation
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Low back pain, interoceptive awareness, motor imagery, massage

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Umberto I Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Massage therapy and contact experience

Massage therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change of McGill Pain Questionnaire from baseline to 12 weeks
This scales evaluates the degree of functional impairment in activities of daily life caused by pain. It consist of ten sections including pain intensity, personal care, lifting, walking, sitting standing, sleeping, sex, social life and travelling. Each section includes six sentences relating to different level of limitation in the same activity (0: no limitation, 5: maximal limitation).
Change of Multidimensional Assessment of Interoceptive Awareness (MAIA) from baseline to 12 weeks
The questionnaire is divided into 32 items organized into eight subcategories consisting of three to seven items each. The subcategories measure: the awareness of unpleasant, pleasant or neutral body sensations, the tendency not to ignore the feelings of pain or discomfort, not to worry about painful sensations or discomfort, the ability not to draw attention away from body sensations, awareness of the existence of connections between body sensations and emotional status, the ability to control the psychological stress by focusing on body sensations, the ability to listen to your body and the belief that the experiences coming from your body are safe and reliable. It 'a multidimensional assessment questionnaire and self-administered. For each subcategory, the patient may express a score from 0 (never) to 5 (always), the highest score corresponds to a higher level of awareness.
Change of SF-12 Health Survey Questionnaire from baseline to 12 weeks
The questionnaire consist in twelve questions that explore eight sub-categories that measure the physical activity, role limitations due to physical health and emotional state, physical pain, the perception of general health, vitality, social activities, mental health and changes in health status and two indices that summarize the overall assessment of the subject with respect to his physical health (ISF) and mental (ISM).
Change of Waddell Disability Index from baseline to 12 weeks
It includes nine parameters: pain experienced in a sitting position, travelling, standing,walking and lifting weights and the need to put on or remove footwear, sleep disturbance, life restriction and sex life restriction to measure. The maximum score is 9 points. A score > 5 indicates significant disability.
Change of hearth rate variability (HRV) expressed as coherent ratio from baseline to 4 weeks
Its an index monitored by a plethysmograph that records the heart rate variability (variation in the time interval between a heartbeat and the other) a parameter capable of expressing a person's level of stress through the coherence ratio.

Full Information

First Posted
January 3, 2016
Last Updated
May 17, 2016
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT02646280
Brief Title
Myofascial Massage in the Treatment of Chronic Low Back Pain
Official Title
The Myofascial Massage in the Treatment of Chronic Non-specific Low Back Pain: the Experience of Contact
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Low back pain, interoceptive awareness, motor imagery, massage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Massage therapy and contact experience
Arm Type
Experimental
Arm Description
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.
Arm Title
Massage therapy
Arm Type
Active Comparator
Arm Description
Traditional massage therapy consisting of different phases: surface touch, deep touch, static pressures, dynamic pressures and kneading.
Intervention Type
Other
Intervention Name(s)
Massage therapy
Intervention Description
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
Intervention Name(s)
Neurocognitive rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
Description
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.
Time Frame
baseline, 4 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change of McGill Pain Questionnaire from baseline to 12 weeks
Description
This scales evaluates the degree of functional impairment in activities of daily life caused by pain. It consist of ten sections including pain intensity, personal care, lifting, walking, sitting standing, sleeping, sex, social life and travelling. Each section includes six sentences relating to different level of limitation in the same activity (0: no limitation, 5: maximal limitation).
Time Frame
baseline, 4 weeks, 12 weeks
Title
Change of Multidimensional Assessment of Interoceptive Awareness (MAIA) from baseline to 12 weeks
Description
The questionnaire is divided into 32 items organized into eight subcategories consisting of three to seven items each. The subcategories measure: the awareness of unpleasant, pleasant or neutral body sensations, the tendency not to ignore the feelings of pain or discomfort, not to worry about painful sensations or discomfort, the ability not to draw attention away from body sensations, awareness of the existence of connections between body sensations and emotional status, the ability to control the psychological stress by focusing on body sensations, the ability to listen to your body and the belief that the experiences coming from your body are safe and reliable. It 'a multidimensional assessment questionnaire and self-administered. For each subcategory, the patient may express a score from 0 (never) to 5 (always), the highest score corresponds to a higher level of awareness.
Time Frame
baseline, 4 weeks, 12 weeks
Title
Change of SF-12 Health Survey Questionnaire from baseline to 12 weeks
Description
The questionnaire consist in twelve questions that explore eight sub-categories that measure the physical activity, role limitations due to physical health and emotional state, physical pain, the perception of general health, vitality, social activities, mental health and changes in health status and two indices that summarize the overall assessment of the subject with respect to his physical health (ISF) and mental (ISM).
Time Frame
baseline, 4 weeks, 12 weeks
Title
Change of Waddell Disability Index from baseline to 12 weeks
Description
It includes nine parameters: pain experienced in a sitting position, travelling, standing,walking and lifting weights and the need to put on or remove footwear, sleep disturbance, life restriction and sex life restriction to measure. The maximum score is 9 points. A score > 5 indicates significant disability.
Time Frame
baseline, 4 weeks, 12 weeks
Title
Change of hearth rate variability (HRV) expressed as coherent ratio from baseline to 4 weeks
Description
Its an index monitored by a plethysmograph that records the heart rate variability (variation in the time interval between a heartbeat and the other) a parameter capable of expressing a person's level of stress through the coherence ratio.
Time Frame
baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo Maria Saraceni
Organizational Affiliation
Umberto I Hospital, University "Sapienza" of Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umberto I Hospital
City
Rome
ZIP/Postal Code
00165
Country
Italy

12. IPD Sharing Statement

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Myofascial Massage in the Treatment of Chronic Low Back Pain

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