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Effects of Spinal Manipulation in Patients With Nonspecific Low Back Pain

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05080374
Enrollment
90
Registered
2021-10-15
Start date
2021-08-11
Completion date
2021-09-11
Last updated
2021-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain, Back Pain, Low, Lumbar Pain Syndrome

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

Interventions

OTHERSpinal Manipulation + exercise program

high-speed, low-amplitude spinal manipulation plus a trunk exercise program

OTHERSpinal manipulation + Kinesiotaping

high-speed, low-amplitude spinal manipulation plus elastic bandage (Kinesiotaping) application to the trunk area

OTHERspinal manipulation + respiratory exercise

high-speed, low-amplitude spinal manipulation plus a breathing exercise program for the diaphragmatic muscles

Sponsors

Ignacio Alejandro Astudillo Ganora
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
changes in pain EVAbaseline after 6 weeks and a monthobserve changes in pain through visual analogue scale (VAS) 0 to 10
Changes in pain pressure algometersbaseline after 6 weeks and a monthobserve changes in pain in painful points through a pressure monitor (painmeter) (0 to 10 kilograms 0 to 22 pounds)
Biomechanical changes (lateral tilt test)baseline after 6 weeks and a monthobserve the changes in the biomechanics of the spine through the lateral tilt test (centimeters from the tip of the middle finger to the ground)
biomechanical changes (finger-floor test)baseline after 6 weeks and a monthobserve the changes in the biomechanics of the spine through the finger-floor test (centimeters from the tip of the middle finger to the ground)
Biomechanical changes (shober test)baseline after 6 weeks and a monthobserve the changes in the biomechanics of the spine through the Shober test (Schöber test. It is performed with the patient standing and the examiner on his back. A point is indicated that locates L5 (at the height of the dimples of Venus or the iliac crests are used, which correspond to L4, and is marked 1cm below) and a second point is marked 10cm above.)
changes in functionbaseline after 6 weeks and a monthobserve changes in disability due to nonspecific low back pain through the Oswestry test (The Oswestry Test comprises 10 items, of 10 points each, with a maximum of 100, this score being the worst possible functional state.)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026