Chronic Low-back Pain
Conditions
Keywords
chronic low back pain, Dry needling, Percutaneous electrolysis
Brief summary
The aim of this study is to evaluate the reduction of pain of two different treatments in patients with chronic low back pain. Patients were divided in two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles.
Detailed description
Background: Low back pain is one of the most common health problems and a leading cause of disability and absence from work. Between 70% and 80% of adults will experience an episode of low back pain and approximately 10.0% of them will become chronic. This has a direct impact on the lumbar stabilizing muscles, giving rise to both structural and functional changes. Among the different treatment options, it has been observed that both dry needling (DN) and percutaneous electrolysis (PE) are effective techniques in the management of musculoskeletal pain. Aim: To evaluate whether the reduction of pain after the application of PE is superior to the one obtained with DN. Methods: A single-blind randomized clinical trial will be conducted in patients with chronic low back pain. The subjects will be divided into two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles. The study variables will be: pain (VAS), disability index (Oswestry Scale), fear of movement (TSK-11SV) and quality of life (SF-12). The measurements will be assessed before, right after and 7 days after a single intervention.
Interventions
OTHERDry needling
It consists in application of dry needling on active and/or latent TPs in low back multifidus muscles
It consists in the application of intratissue percutaneous electrolysis with galvanic current as a cathodic flow electrode in the low back multifidus muscles. The intervention will be guided by ultrasound equipment medically certified.
Sponsors
University of Alcala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
40 sealed opaque envelopes will be prepared. 20 of the envelopes will contain ballots corresponding to the DN control group and 20 to the PE group. Only the examiner who will carry out the intervention will know the group of each participant. The main examiner will be the one who monitors the intervention without knowing which group each participant belongs to.
Intervention model description
The subjects will be divided into two groups. The control group will receive DN treatment, and the experimental group will receive PE, both in the lumbar multifidus muscles.
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Low back pain ≥ 3 months. * Age between 30 and 60 years old. * Not being receiving other physical therapy
Exclusion criteria
* Diagnosis of specific lumbar pathology. * History of previous lumbar surgery. * Treatment with corticosteroids, anti-inflammatory or antibiotic medication in recent weeks. * Oncological processes, febrile symptoms or thrombophlebitis. * Skin conditions. * Belonephobia. * Pacemaker. * Pregnancy. * Patients with neurological pathology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity. Visual analogue scale. | At baseline, at 1 week after the last intervention, and 6-month follow-up period | A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability. Oswestry Low Back Pain Disability Idex | At baseline, at 1 week after the last intervention, and 6-month follow-up period | It has 10 items associated to activities of daily living, each item has a punctuation from 0 to 5 points |
| Fear of Movement. Tampa Scale of kinesiophobia (TSK-11SV) | At baseline, at 1 week after the last intervention, and 6-month follow-up period | Is a 11-item questionnaire that measures the fear of movement and (re)injury. |
| Quality of life. SF-12 Health questionnaire. | At baseline, at 1 week after the last intervention, and 6-month follow-up period | SF-12 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life |
Countries
Spain
Contacts
Primary ContactLeire Lopez de Calle Sánchez, Grade
Backup ContactSamuel Fernandez Carnero, PhD
Outcome results
None listed