Effects of Spinal Manipulation in Patients With Nonspecific Low Back Pain
Primary Purpose
Back Pain, Lumbar Pain Syndrome, Back Pain, Low
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Spinal Manipulation + exercise program
Spinal manipulation + Kinesiotaping
spinal manipulation + respiratory exercise
Sponsored by
About this trial
This is an interventional treatment trial for 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)
Sites / Locations
- Physiotherapy deparment, Murcia University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
HVLA + exercise Group
HVLA + kinesiotaping group
HVLA + Respiratory exercise group
Arm Description
Spinal manipulation (HVLA) + trunk exercise program
Spinal manipulation (HVLA) + Kinesiotaping (lumbar)
Spinal manipulation (HVLA) + respiratory exercise program
Outcomes
Primary Outcome Measures
changes in pain EVA
observe changes in pain through visual analogue scale (VAS) 0 to 10
Changes in pain pressure algometers
observe changes in pain in painful points through a pressure monitor (painmeter) (0 to 10 kilograms 0 to 22 pounds)
Biomechanical changes (lateral tilt test)
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)
biomechanical changes (finger-floor test)
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)
Biomechanical changes (shober test)
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.)
changes in function
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.)
Secondary Outcome Measures
Full Information
NCT ID
NCT05080374
First Posted
September 23, 2021
Last Updated
October 4, 2021
Sponsor
Ignacio Alejandro Astudillo Ganora
1. Study Identification
Unique Protocol Identification Number
NCT05080374
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
September 11, 2021 (Actual)
Study Completion Date
September 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ignacio Alejandro Astudillo Ganora
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Lumbar Pain Syndrome, Back Pain, Low
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HVLA + exercise Group
Arm Type
Experimental
Arm Description
Spinal manipulation (HVLA) + trunk exercise program
Arm Title
HVLA + kinesiotaping group
Arm Type
Experimental
Arm Description
Spinal manipulation (HVLA) + Kinesiotaping (lumbar)
Arm Title
HVLA + Respiratory exercise group
Arm Type
Experimental
Arm Description
Spinal manipulation (HVLA) + respiratory exercise program
Intervention Type
Other
Intervention Name(s)
Spinal Manipulation + exercise program
Intervention Description
high-speed, low-amplitude spinal manipulation plus a trunk exercise program
Intervention Type
Other
Intervention Name(s)
Spinal manipulation + Kinesiotaping
Intervention Description
high-speed, low-amplitude spinal manipulation plus elastic bandage (Kinesiotaping) application to the trunk area
Intervention Type
Other
Intervention Name(s)
spinal manipulation + respiratory exercise
Intervention Description
high-speed, low-amplitude spinal manipulation plus a breathing exercise program for the diaphragmatic muscles
Primary Outcome Measure Information:
Title
changes in pain EVA
Description
observe changes in pain through visual analogue scale (VAS) 0 to 10
Time Frame
baseline after 6 weeks and a month
Title
Changes in pain pressure algometers
Description
observe changes in pain in painful points through a pressure monitor (painmeter) (0 to 10 kilograms 0 to 22 pounds)
Time Frame
baseline after 6 weeks and a month
Title
Biomechanical changes (lateral tilt test)
Description
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)
Time Frame
baseline after 6 weeks and a month
Title
biomechanical changes (finger-floor test)
Description
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)
Time Frame
baseline after 6 weeks and a month
Title
Biomechanical changes (shober test)
Description
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.)
Time Frame
baseline after 6 weeks and a month
Title
changes in function
Description
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.)
Time Frame
baseline after 6 weeks and a month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Physiotherapy deparment, Murcia University
City
Murcia
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Spinal Manipulation in Patients With Nonspecific Low Back Pain
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