Myofascial Massage in the Treatment of Chronic Low Back Pain
- Conditions
- Chronic Low Back Pain
- Interventions
- Other: Massage therapyOther: Neurocognitive rehabilitation
- Registration Number
- NCT02646280
- Lead Sponsor
- University of Roma La Sapienza
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- Presence of chronic nonspecific low back pain for at least three months
- Subjects aged between 18 and 50 years
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Massage therapy Massage therapy Traditional massage therapy consisting of different phases: surface touch, deep touch, static pressures, dynamic pressures and kneading. Massage therapy and contact experience Neurocognitive rehabilitation 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. Massage therapy and contact experience Massage therapy 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.
- Primary Outcome Measures
Name Time Method Change of Visual Analogue Scale (VAS) from baseline to 12 weeks 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 Outcome Measures
Name Time Method Change of Multidimensional Assessment of Interoceptive Awareness (MAIA) from baseline to 12 weeks 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.
Change of SF-12 Health Survey Questionnaire from baseline to 12 weeks 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).
Change of hearth rate variability (HRV) expressed as coherent ratio from baseline to 4 weeks 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.
Change of McGill Pain Questionnaire from baseline to 12 weeks 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).
Change of Waddell Disability Index from baseline to 12 weeks 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.
Trial Locations
- Locations (1)
Umberto I Hospital
🇮🇹Rome, Italy