Clinical trial NCT04384185: Combined Treatment of Manual Therapy and Therapeutic Exercise in Patients With Low Back Pain
Official title: Effectiveness of a Therapeutic Exercise Protocol Combined With Manual Therapy Techniques on the Diaphragm Muscle in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Mechanical
Musculoskeletal Manipulations
Exercise Training
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: MAIN OBJECTIVE: to assess whether an exercise protocol on the lumbar musculature by adding manual therapy techniques on the diaphragm muscle has the same or greater effect on chronic non-specific lumbar pain than an isolated exercise protocol.

SECONDARY OBJECTIVES: to evaluate the effectiveness of a lumbar exercise protocol in chronic non-specific low back pain in isolation; To evaluate the effectiveness of both therapies in improving joint range in patients with chronic non-specific low back pain and, finally, to assess catastrophism and the avoidance of lumbar mobility when carrying out loaded movements.

HYPOTHESIS: that a lumbar exercise protocol combined with manual therapy treatment on the diaphragm is equal or more effective on pain in patients with chronic nonspecific low back pain than treatment with the same lumbar exercise protocol in isolation.

Detailed description: METHODOLOGY: A prospective randomized clinical trial with two types of intervention (lumbar exercise protocol and manual diaphragm therapy) will be carried out. The variables to be measured are pain, disability, mobility and kinesiophobia. It will be performed in two groups of 21 people who are of legal age, who have low back pain of more than 3 months duration and which is of non-specific origin.

The patients will be randomized and divided into two groups A (control) and B (experimental).

Group A will undergo an exercise protocol.

Group B will undergo the same protocol plus manual therapy techniques on diaphragm muscle. Study participants will have treatment twice a week for 8 weeks, the first information session and the second measurement-evaluation session in the first week of treatment. In the following 3 weeks the session will last 40 minutes for both groups. In the 4th week the established measurements will be carried out again.

Eligibility criteria: Inclusion Criteria:

* Legal age
* Non-specific Low-Back pain
* Pain more 3 months

Exclusion Criteria:

* subjects with lumbar herniation.
* Spine canal stenosis
* Subjects with neurological disease.
* Lumbar surgery

Primary outcomes:
measure: Low-back pain
timeFrame: Change from Baseline disability at 3 months
Secondary outcomes:
measure: Disability with Oswestry Disability Index
timeFrame: Change from Baseline disability at 3 months
measure: Lumbar range of motion
timeFrame: Change from Baseline disability at 3 months
measure: Kinesiophobia
timeFrame: Change from Baseline disability at 3 months
Other outcomes:
Locations:
city: Alcala de Henares
country: Spain
facility: Grupo Fisioterapia y Dolor
state: Madrid
Study officials:
affiliation: Alcala University
name: Tomas Gallego Izquierdo, PhD
role: STUDY_CHAIR
References: