Clinical trial NCT04924387: Manual Therapy and Exercise in Low Back Pain
Official title: Effects of a Procedure Programme in Patients With Non-specific Low Back Pain. Comparative Intervention Based on Therapeutic Exercise, Therapeutic Exercise With Kinesio Tape and Manual Therapy Prior to the Therapeutic Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: chronic pain
manipulation, musculoskeletal
catastrophisation
kinesiotaping
exercise
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-specific low back pain is one of the main causes of disability for health care worldwide. The effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques. Moreover, can these techniques be combined?

Detailed description: Non-specific low back pain is one of the main causes of disability for health care worldwide. Nowadays, the mostly used technique to research low back muscular activity is electromyography.

Among the published studies, the effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques.

The main objective that is aimed by this thesis, is the evaluation of muscular activation in the reduction of non-specific low back pain through a 12 weeks procedure programme, which includes therapeutic exercise combined with other treatment techniques, and assessing the psycho-social characteristics of pain.

This study's population will be composed by at least 16 individuals per group, both male and female, with ages among 20 and 80.

Participants will be randomly and blindly divided in three groups of intervention. The three groups will be: the experimental group or EXP Group (all participants subject to therapeutic exercise), the experimental group, which will also be subject to manual therapy (MT Group) and finally, the experimental group, which will also be subject to kinesio tape work (KT Group).

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with low back pain.
* Patients who are in Stage 1 of the Oswestry scale.
* Not receiving pharmacological treatment such as anti-inflammatories or corticosteroids
* Be able to understand the exercises and spanish language.

Exclusion Criteria:

* Having any back surgery.
* Be taking any medication at the time of the study.
* Have a pathology in which exercise is contraindicated (spondylolisthesis, spondylolysis, spondyloarthrosis).
* Be in a state of gestation or if there is the possibility of being.
* Present or have presented some oncological process.

Primary outcomes:
measure: Oswestry
timeFrame: (12 weeks)
Secondary outcomes:
measure: Kinesiophobia (TKS)
timeFrame: (12 weeks)
measure: Catastrophism (PCS)
timeFrame: (12 weeks)
measure: Self-efficacy: questionnaire
timeFrame: (12 weeks)
measure: Visual analog scale (VAS)
timeFrame: (12 weeks)
measure: Pressure algometry
timeFrame: (12 weeks)
measure: Electromyography
timeFrame: (12 weeks)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: FundacionUCV
Study officials:
affiliation: Fundación Universidad Católica de Valencia San Vicente Mártir
name: Juan Vicente Mampel, Phd
role: STUDY_DIRECTOR
References:
citation: Ozsoy G, Ilcin N, Ozsoy I, Gurpinar B, Buyukturan O, Buyukturan B, Kararti C, Sas S. The Effects Of Myofascial Release Technique Combined With Core Stabilization Exercise In Elderly With Non-Specific Low Back Pain: A Randomized Controlled, Single-Blind Study. Clin Interv Aging. 2019 Oct 9;14:1729-1740. doi: 10.2147/CIA.S223905. eCollection 2019.