Myofascial Massage in the Treatment of Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

The Myofascial Massage in the Treatment of Chronic Non-specific Low Back Pain: the Experience of Contact

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646280
• Other study ID #: 3791/2015
• Status: Completed
• Phase: N/A
• First received: January 3, 2016
• Last updated: May 17, 2016
• Start date: July 2015
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Italy	Umberto I Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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).	baseline, 4 weeks, 12 weeks	Yes
Secondary	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.	baseline, 4 weeks, 12 weeks	Yes
Secondary	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).	baseline, 4 weeks, 12 weeks	Yes
Secondary	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.	baseline, 4 weeks, 12 weeks	Yes
Secondary	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.	baseline, 4 weeks	Yes