Clinical trial NCT02103036: Valuation of the Low Back Pain Treated With Different Types of Active Exercises in Women
Official title: Valuation of the Low Back Pain Treated With Different Types of Active Exercises in Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Core stability exercise
Back school
TENS
Infra- red light
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
Collaborators: name: Hospital Universitari Sant Joan de Reus
First posted: 2014-04-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is determine whether the Core Stability Exercise is more effective than the traditional Back School for low back pain (LBP) in women.

Detailed description: The aim of this study is to check what kind of exercises are the best to treat LBP with regard to clinical improvements. The secondary objectives are: to determine which treatment is more effective in improving pain in the fewest sessions possible, to determine the involvement of inflammatory biomarkers in the development of pain and revalue the results after one month of having finishing treatment.

The project is a longitudinal, single-blind and randomized study with two treatment groups:

GROUP 1: Infrared light+ Transcutaneous Electrical Nerve Stimulation (TENS) + Core Stability Exercises.

GROUP 2: Infrared light + Transcutaneous Electrical Nerve Stimulation (TENS) + Traditional Back School.

Duration of treatment: 4 weeks. The participants will performe the exercises in 20 daily sessions (Monday to Friday) guided by a physiotherapist. Following treatment with the physiotherapist, the participants should perform the exercises at home for 4 weeks at a rate of three times per week.

Eligibility criteria: Inclusion Criteria:

* Women aged 18 to 70 years.
* Diagnosis of back pain from a trauma.
* Untreated pain (except acetaminophen).
* Informed consent.

Exclusion Criteria:

* Algic process in the lumbar spine of infectious, neoplastic, metastasis, osteoporosis, inflammatory arthritis or fractures.
* Cognitive impairment of any etiology.
* Exercise intolerance for any reason.
* Patients who have completed physical therapy in the last 3 months.
* Patients who have received infiltration injections in the last 6 weeks.

Primary outcomes:
measure: Changes in Visual Scale Analogue (VAS)
timeFrame: Pain was measured at the beginning of the study (session 0), and changes are evaluated again at sessions 10, 20, and 1 month later.
Secondary outcomes:
measure: Changes in the Roland- Morris Disability Questionnaire
timeFrame: Disability was measured at the beginning of the study (session 0), and changes are evaluated again at sessions 10, 20, and 1 month later.
Other outcomes:
measure: Questionnaire of Physical Activity (ClassAF)
timeFrame: The physical activity will be measured at the beginning of the study (session 0).
measure: Changes in the biomarkers: Tumor Necrosis Factor (TNF-Alpha) and Interleukin 10 (IL-10)
timeFrame: The concentrations of these biomarkers will be measured at the beginning (session 0) and changes will be evaluated again at the end of the treatment (session 20).
Locations:
city: Reus
country: Spain
facility: Faculty of Medicine and Health Sciences
state: Tarragona
Study officials:
affiliation: Faculty of Medicine and Health Sciences. Rovira i Virgili University. Spain.
name: Rosa Nogués, Pharm.D.
role: STUDY_DIRECTOR
References:
citation: Minobes-Molina E, Nogues MR, Giralt M, Casajuana C, de Souza DLB, Jerez-Roig J, Romeu M. Effectiveness of specific stabilization exercise compared with traditional trunk exercise in women with non-specific low back pain: a pilot randomized controlled trial. PeerJ. 2020 Nov 27;8:e10304. doi: 10.7717/peerj.10304. eCollection 2020.