Chronic Low Back PainNCT02646280
Myofascial Massage in the Treatment of Chronic Low Back Pain
A study testing Massage therapy and Neurocognitive rehabilitation in people with Chronic Low Back Pain, run by University of Roma La Sapienza at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Massage therapy and Neurocognitive rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of chronic nonspecific low back pain for at least three months
- Subjects aged between 18 and 50 years
Who cannot join
- 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
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- Previous Surgery
- Cognitive impairment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Myofascial Massage in the Treatment of Chronic Non-specific Low Back Pain: the Experience of Contact
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).
- Conditions
- Chronic Low Back Pain
- Being tested
- Massage therapy, Neurocognitive rehabilitation
- Keywords
- Low back pain, interoceptive awareness, motor imagery, massage
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Massage therapy; Other: Neurocognitive rehabilitation |
| Massage therapy | Active comparator | Traditional massage therapy consisting of different phases: surface touch, deep touch, static pressures, dynamic pressures and kneading. Receives: Other: Massage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 4 weeks, 12 weeks
Secondary outcomes (5)
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).
Measured: baseline, 4 weeks, 12 weeks
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.
Measured: baseline, 4 weeks, 12 weeks
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).
Measured: baseline, 4 weeks, 12 weeks
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.
Measured: baseline, 4 weeks, 12 weeks
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.
Measured: baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Paolucci, University of Roma La Sapienza
- Investigators
- Vincenzo Maria Saraceni, Principal investigator, Umberto I Hospital, University "Sapienza" of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646280
- Sponsor's protocol ID
- 3791/2015
- Status last verified
- May 2016
- First submitted
- 3 Jan 2016
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Myofascial Massage in the Treatment of Chronic Non-specific Low Back Pain: the Experience of Contact
- ClinicalTrials.gov ID
- NCT02646280
- Acronym / sponsor ID
- 3791/2015
- Conditions
- Chronic Low Back Pain
- Keywords
- Low back pain, interoceptive awareness, motor imagery, massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage therapy and contact experience | Experimental | Other: Massage therapy, Other: Neurocognitive rehabilitationTraditional 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 | Active comparator | Other: Massage therapyTraditional massage therapy consisting of different phases: surface touch, deep touch, static pressures, dynamic pressures and kneading. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Presence of chronic nonspecific low back pain for at least three months
- Subjects aged between 18 and 50 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage therapyMassage therapy as a treatment option to induce a relaxation and a reduction of pain and stress in patients affected by chronic low back pain. | Other | Massage therapy, Massage therapy and contact experience |
| Neurocognitive rehabilitationProvided through the association of motor imagery and the words of the physiotherapist with the aim of increasing the effectiveness of massage in reducing pain. | Other | Massage therapy and contact experience |
Primary outcome
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.
5 secondary outcomes
Change of McGill Pain Questionnaire from baseline to 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Change of Multidimensional Assessment of Interoceptive Awareness (MAIA) from baseline to 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Change of SF-12 Health Survey Questionnaire from baseline to 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Change of Waddell Disability Index from baseline to 12 weeks
Time frame: baseline, 4 weeks, 12 weeks
Change of hearth rate variability (HRV) expressed as coherent ratio from baseline to 4 weeks
Time frame: baseline, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Maria Saraceni principal investigator
Umberto I Hospital, University "Sapienza" of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage therapy and Neurocognitive rehabilitation in people with Chronic Low Back Pain, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Visual Analogue Scale (VAS) from baseline to 12 weeks (time frame: baseline, 4 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.