Clinical trial NCT03181659: Therapeutic Exercise and Therapeutic Patient Education With or Without Manual Therapy for Chronic Nonspecific Low Back Pain.
Official title: Therapeutic Exercise and Therapeutic Patient Education With or Without Manual Therapy for Chronic Nonspecific Low Back Pain: a Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Nonspecific Low Back Pain
Low Back Pain
Keywords: Musculoskeletal Manipulations
Exercise
Patient Education
Low back pain
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
Collaborators: name: Centro Universitario La Salle
name: Servicio Madrileño de Salud, Madrid, Spain
name: Universidad Autonoma de Madrid
First posted: 2017-06-09
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial study evaluates the effectiveness of a multimodal physiotherapy treatment based on a biobehavioural paradigm in the treatment of non-specific chronic low back pain. The experimental group received treatment based on therapeutic exercise, education in neuroscience, and manual therapy, contrary to the control group, which did not receive manual therapy treatment.

Detailed description: Low back Pain (LBP) is defined by patients as a pain located between the low margins of the costal gridiron and the top limits of the buttock musculature, and it can either be of short or long duration. LBP is the most prevalent musculoskeletal problem, assuming a prevalence between 18,6% and 57,4%. Traditionally, the diagnosis of the DL continues to be based on pathoanatomical criteria even though, in numerous occasions, the outcomes found in complementary tests of image do not correlate with the intensity of pain and the level of disability of the patients. According to the guides of clinical practice, LBP can be divided in three subgroups: firstly, patients whose pain can be associated to a previous pathology, secondly, patients with a diagnosed neuropathic pain associated to a neurological condition, and lastly, patients who present LBP of unspecific characteristics, not preceded by any pathology or relevant damage. According to the World Health Organization, the latter represent 90% of the cases. Thus, this problem supposes a high index of chronicity, and it is the principal reason of labor absenteeism and disability encountered in society, as well as one of the most common motives of consultation in centers of primary care and specialized attention, which results in a high socioeconomic cost. As for the intervention of the CLBP, nowadays there are numerous studies based on disabling the processing of central and peripheral levels of pain by means of a multidisciplinary boarding based on psychology and on a biobehavioral approach. The aim of this study is to evaluate the efficiency of a multimodal treatment by means of therapeutic exercise (TE) and education in neuroscience (NE), with or without manual therapy (MT).

TE is one of the most frequently used techniques, and one of the most effective in patients with CLBP. Research shows reduction of pain in healthy people through either aerobic exercise, resistance exercise, or isometric exercise, showing an increase in pain thresholds and pain intensity. NE aims to change maladaptive beliefs and erroneous thoughts that interfere in the perception of pain and which lead to increase the presence of psychological variables such as fear of movement, hypervigilance, and catastrophism, enhancing the perpetuation and chronicity of the same. Additionally, MT offers a wide range of specific techniques for the treatment of musculoskeletal disorders with the aim of obtaining a modulation of pain through the neurophysiological effects produced at both peripheral and central levels.

The hypothesis of the present study is that TE, when combined with both NE and MT, is more effective on the principal variables of study after 3 months of follow-up. It is a clinical trial randomized with masking of the assessor. An evaluation of the variables previously described will take place, and it will be measured by a trained physical therapist before receiving the treatment. The second evaluation will be conducted after finishing the intervention, whereas a last evaluation will be undertaken after 3 months of follow-up. The intervention will be carried out by a specialized physical therapist that will use a multimodal approach in a simple, randomized way by means of the software known as GraphPad, which allows us to randomly divide the participants into two groups. The group control will receive a treatment based on a total of 8 sessions, at a rate of 2 sessions per week. In total, a number of 4 sessions of NE will take place once per week during a period of four weeks, together with 7 TE sessions. The experimental group will receive the same intervention that the control group in combination with TM based on a protocol, which will develop during a period of 20-25 minutes, 2 sessions per week, in a total of 8 sessions. Groups will have to continue receiving NE and, regularly, they will receive a total of 4 follow-ups on the process of education via audio-visual material.

Eligibility criteria: Inclusion Criteria:

* Patients with non specific low back pain lasting for at least 3 months.
* Patients with pain intensity corresponding to at least 3 points on a 10 point analogue visual scale.
* Patients with pain frequency corresponding to at least 10 days per month.
* Men and Women between 18 and 65 years old.

Exclusion Criteria:

* Presence of trauma or surgery to the thoracic or lumbar region.
* Patients with diagnosis of discopathy or radicular symptoms.
* Patients with history of previous physical-therapy intervention for the lumbar region in the last month.
* Any cognitive impairment that hindered viewing of audiovisual material.
* difficulty understanding or communicating.
* Presence of systemic pathology, Central Nervous System or rheumatic disease.
* Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
* Collaboration of pregnant women.

Primary outcomes:
measure: Disability and function
timeFrame: Change from disability and function at 3 months.
measure: Pain Intensity
timeFrame: Change from pain intensity at 3 months.
measure: Isometric Force Endurance
timeFrame: Change from Isometric force endurance at 3 months.
Secondary outcomes:
measure: Temporal Summation
timeFrame: Temporal Summation will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.
measure: Two-point discrimination
timeFrame: Two-Point discrimination will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.
measure: Funcional range
timeFrame: Funcional range will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.
measure: Strength of lumbar region
timeFrame: Strength of the lumbar region will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.
measure: Motor control of lumbar region
timeFrame: Motor control will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.
measure: Range of movement
timeFrame: Range of movement will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.
measure: Dynamic Stability
timeFrame: Dynamic Stability will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.
measure: Pain catastrophizing
timeFrame: Pain catastrophizing will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.
measure: Kinesiophobia
timeFrame: Kinesiophobia will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.
measure: Self-efficacy
timeFrame: Self-efficacy will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.
measure: Anxiety and Depression
timeFrame: Anxiety and Depression will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
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