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NCT Number: NCT05080374

Effects of Spinal Manipulation in Patients With Nonspecific Low Back Pain

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

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Key information

Conditions

Back Pain Back Pain, Low Low Back Pain Lumbar Pain Syndrome Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Somatoform Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physiotherapy deparment, Murcia University

Murcia, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Spinal Manipulation + exercise program

Other

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

Spinal manipulation + Kinesiotaping

Other

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

spinal manipulation + respiratory exercise

Other

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

Primary outcomes

  1. changes in pain EVA

    Time frame: baseline after 6 weeks and a month

    observe changes in pain through visual analogue scale (VAS) 0 to 10

  2. Changes in pain pressure algometers

    Time frame: baseline after 6 weeks and a month

    observe changes in pain in painful points through a pressure monitor (painmeter) (0 to 10 kilograms 0 to 22 pounds)

  3. Biomechanical changes (lateral tilt test)

    Time frame: baseline after 6 weeks and a month

    observe the changes in the biomechanics of the spine through the lateral tilt test (centimeters from the tip of the middle finger to the ground)

  4. biomechanical changes (finger-floor test)

    Time frame: baseline after 6 weeks and a month

    observe the changes in the biomechanics of the spine through the finger-floor test (centimeters from the tip of the middle finger to the ground)

  5. Biomechanical changes (shober test)

    Time frame: baseline after 6 weeks and a month

    observe 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.)

  6. changes in function

    Time frame: baseline after 6 weeks and a month

    observe 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.)

Sponsors and collaborators

Lead sponsor

Ignacio Alejandro Astudillo Ganora

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 15, 2021
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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