Clinical trial NCT05080374: Effects of Spinal Manipulation in Patients With Nonspecific Low Back Pain
Official title: Effects of Combining High Speed Low Amplitude Spinal Manipulation (HVLA) With Functional Elastic Bandage, Diaphragm Training and a Lumbar Exercise Program in Patients With Nonspecific Low Back Pain: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Lumbar Pain Syndrome
Back Pain, Low
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Nonspecific low back pain is the most common cause of visits to medical personnel and is the largest cause of absenteeism in the world. (1), Nonspecific low back pain accounts for 85% of low back pain, notably affecting quality of life and working life (2), There is a 50-70% probability that a person will have low back pain during their life ( 3), lumbago produces 300,000 years lived with disability (ADL), being the first burden of disease in Chile, surpassing hypertensive heart disease and depression (4). There are many therapeutic approaches to the management of nonspecific low back pain, including high-speed, low-amplitude spinal manipulations (5). This technique consists of applying a short and rapid force at the level of the joint that is restricted, in order to restore normal joint mobility. The physiological effects of manipulations are not sufficiently studied, but some authors (6) (7) suggest that the nervous system is the mediator of the effects of spinal manipulation. Among non-pharmacological interventions, numerous clinical guidelines recommend the use of therapeutic exercise for low back pain (8), including a wide variety of types of recommended exercises, the most traditionally recommended being aerobic exercises, exercises that involve stretching postures of the back. vertebral musculature, strengthening and strength exercises (9) and central stabilization exercises (10). Recently, the effects of inspiratory muscle and diaphragm training exercises in patients with low back pain are being investigated (11). The application of an elastic bandage (12) in the lumbar area generates a proprioceptive signal through the skin, producing analgesia and a feeling of support in the area.

Objectives: To compare the effects of different therapeutic approaches in combination with spinal manipulation.

Design and method: Single-blind randomized clinical trial Results: Significant differences are expected before and after treatment and differences between groups.

Conclusion: The aims of this study is to demonstrate that High speed and low amplitude spinal manipulation plus other conservative treatment is a valid therapeutic strategy for the management of nonspecific low back pain


Eligibility criteria: Inclusion Criteria:

* older than 18 years
* with nonspecific low back pain

Exclusion Criteria:

* chronic low back pain (more than 3 months)
* spinal surgeries
* red flags for spinal manipulation (osteoporosis, bone metastasis, etc)

Primary outcomes:
measure: changes in pain EVA
timeFrame: baseline after 6 weeks and a month
measure: Changes in pain pressure algometers
timeFrame: baseline after 6 weeks and a month
measure: Biomechanical changes (lateral tilt test)
timeFrame: baseline after 6 weeks and a month
measure: biomechanical changes (finger-floor test)
timeFrame: baseline after 6 weeks and a month
measure: Biomechanical changes (shober test)
timeFrame: baseline after 6 weeks and a month
measure: changes in function
timeFrame: baseline after 6 weeks and a month
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Physiotherapy deparment, Murcia University
Study officials:
References: