Clinical trial NCT05544890: Effects of Core Exercise in Low Back Pain
Official title: Core Stability (Therapeutic) Exercise Alone or in Combination With Manual Therapy or Kinesio Tape in Patients With Chronic Low Back Pain: Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Chronic pain
Muskuloskeletal manipulation
Complementary therapies
Catastrophization
Kinesiophobia
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-specific low back pain in 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 in 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.

Therefore, the purpose of this study was to investigate the effects of core stability exercise alone or in combination with manual therapy or kinesiotape on pain, dysfunction, psychosocial factors and pressure pain threshold (PPTs) in patients with low back pain in ODI stage 2. The investigators hypothesized that exercise combined with manual therapy would provide greater changes and benefits than exercise alone.

This study's population will be composed by at least 15 individuals per group, both the male and female, with ages among 20 and 60.

Participants will be randomly and blindly divided in three groups of intervention. The three groups will be: Exercise group or ET (realize therapeutic exercise alone), manual therapy group o ETmanualtherapy (realize manual therapy prior therapeutic exercise), and kinesiotape group or ETkinesiotape (realize therapeutic exercise plus kinesiotape).

Eligibility criteria: Inclusion Criteria:

* Medical diagnosis of CLBP confirmed by an orthopaedic specialist Classification at Stage 2 by ODI Not receiving pharmacological treatment such as anti-inflammatories or corticosteroids.

Exclusion Criteria:

* Previous or scheduled surgeries in the low back and abdominal area
* Presence of severe fractures or pathologies.
* Diagnosis of radiculopathy or neuropathy (with or without spinal canal stenosis).
* Structural deformity in the spinal column.
* Neurological or psychiatric disorder.
* Presence or suspicion of pregnancy.

Primary outcomes:
measure: Oswestry Disability Index.
timeFrame: 12 weeks
Secondary outcomes:
measure: Catastrophism (PCS)
timeFrame: 12 weeks
measure: Kinesiophobia (TKS)
timeFrame: 12 weeks
measure: Visual analog scale (VAS)
timeFrame: 12 weeks
measure: Self-efficacy:questionnaire
timeFrame: 12 weeks
measure: Pressure pain threshold
timeFrame: 12 weeks
measure: Electromyography
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Castellón De La Plana
country: Spain
facility: Universitat Jaume I
state: Castellón
Study officials:
affiliation: Doctoral School. Catholic University of Valencia San Vicente Mártir
name: Paula Blanco, PDI
role: PRINCIPAL_INVESTIGATOR
References:
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