Effects of Spinal Manipulation in Patients With Nonspecific Low Back Pain

October 4, 2021 updated by: Ignacio Alejandro Astudillo Ganora

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain
        • Physiotherapy deparment, Murcia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HVLA + exercise Group
Spinal manipulation (HVLA) + trunk exercise program
Other: Spinal Manipulation + exercise program
high-speed, low-amplitude spinal manipulation plus a trunk exercise program
Experimental: HVLA + kinesiotaping group
Spinal manipulation (HVLA) + Kinesiotaping (lumbar)
Other: Spinal manipulation + Kinesiotaping
high-speed, low-amplitude spinal manipulation plus elastic bandage (Kinesiotaping) application to the trunk area
Experimental: HVLA + Respiratory exercise group
Spinal manipulation (HVLA) + respiratory exercise program
Other: spinal manipulation + respiratory exercise
high-speed, low-amplitude spinal manipulation plus a breathing exercise program for the diaphragmatic muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline after 6 weeks and a month
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)
baseline after 6 weeks and a month
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)
baseline after 6 weeks and a month
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)
baseline after 6 weeks and a month
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.)
baseline after 6 weeks and a month
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.)
baseline after 6 weeks and a month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ignacio Alejandro Astudillo Ganora

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2021

Primary Completion (Actual)

September 11, 2021

Study Completion (Actual)

September 11, 2021

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3500/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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