About this trial
The goal of this clinical trial is to compare the effectiveness of a stretching, exercise and education protocol versus usual care in improving pain, function and disability in patients with non-specific mechanical chronic low back pain (CLBP). The research hypothesis is: A combination of hip flexors stretching, exercise and education is more effective than usual care to improve pain, function and disability in patients with CLBP.
Participants will be randomly allocated in one of the two treatment groups. Pain, function and disability will be assessed before starting treatment, after the end of the treatment and one month , three months and one year after the end of the treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years
Medical diagnosis of chronic, mechanical, non-specific pain in the lumbar spine (M54, M51) - chronic low back pain.
Obtaining written consent to conduct research
Must be able to swallow tablets
Disqualifiers
Pregnancy
Pacemaker
Active cancer
To consent to conduct research
Trial design
Parallel
Treatments tested in this trial
Multicomponent intervention. Hip flexors stretching, Strengthening exercises and education and medical treatment (Medication and medical counselling)
Other interventionHip flexors stretching (Adaptation from Evjenth and Hamberg) Strengthening Exercise * Deep squats * Flexo-extension of the ankle on a step over the head of metatarsal bones * Plank * Strengthening knee flexors and hip extensors * Lunges with a stick behind the patient back Education Pain relieving positions identified will be taught to the patient to use when they feel their pain. Identifying and learning to avoid pain positions or activities that increase pain. When the pain occur self stretching of hip flexors on the couch or the chair must be done
Medical treatment.
DrugA medical doctor will prescribe the treatment following the standard of care in Polish public health services. Treatment will consist of medication and counseling.
Treatment groups
Trial outcomes
Primary outcomes
Numeric Pain Rating Scale (NPRS)
Numeric Pain Rating Scale (NPRS) The NPRS will be used to ask the patient about the level of pain that he/she feels considering from 0 to 10, where 0 represents the absence of pain and 10 represents the most intense pain, used to measure the pain experienced by the patient. The participant will answer the NPRS, responding to the average, maximum and minimum pain experienced throughout its duration.
Secondary outcomes
Lumbar Range of Motion
The MyoMotion( Noraxon, USA) is a device used to measure degrees of range of motion (ROM) in the lumbar spine. It consists of accelerometers and a program. The range of flexion, extension, will be measured in degrees.
ROM in Thomas test
The MyoMotion( Noraxon, USA) is a device used to measure degrees of range of motion (ROM) in the lumbar spine. It consists of accelerometers and a program. The range of flexion, extension, will be measured in degrees.
Clinical Measure of extension.
To assess a patient's ability to extend their spine, a clinical method will be used and recorded. This method involves asking the patient how far they can reach while looking at a measuring tape.
Anatomical distribution of pain
Patients will draw on a body silhouette the region where they feel pain.
Sponsors and contacts
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Wroclaw University of Health and Sport Sciences
Lead sponsor
Universidad de Zaragoza
Collaborator
Universitat Internacional de Catalunya
Collaborator
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