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Completed

NCT Number: NCT02646280

Myofascial Massage in the Treatment of Chronic Low Back Pain

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).

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umberto I Hospital

Rome, 00165, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Massage therapy

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

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.

Primary outcomes

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

    Time frame: baseline, 4 weeks, 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 outcomes

  1. Change of McGill Pain Questionnaire from baseline to 12 weeks

    Time frame: baseline, 4 weeks, 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).

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

    Time frame: baseline, 4 weeks, 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.

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

    Time frame: baseline, 4 weeks, 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).

  4. Change of Waddell Disability Index from baseline to 12 weeks

    Time frame: baseline, 4 weeks, 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.

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

    Time frame: baseline, 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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jan 5, 2016
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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