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Immediate Effects of a Spinal Lumbar Manipulation

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
HVLA Manipulation
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring non-specific low back pain, center of pressure, spinal lumbar manipulation, high velocity and low amplitude manipulation, postural control

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • recurrent low back pain in the last three months;
  • medical diagnosis of non-specific low back pain, daily or almost daily;
  • subjects that will present at least four variables which encompass the clinical prediction rule: symptoms duration less than 16 days, Fear Avoidance-Beliefs Questionnaire score lower than 19 in the work subscale, segmental lumbar hypermobility test in prone decubitus, internal hip rotation higher than 35 degrees and symptoms that don't pass the knee.

Exclusion Criteria:

  • subjects presenting symptoms that pass the knee;
  • impairment of neurologic signs like sensibility, muscle force and deep tendon reflex;
  • a prior history of spondylolisthesis, spinal stenosis, inflammatory disease, cancer, musculoskeletal degenerative disease, pregnancy, disease and drugs that impairment the balance;
  • subjects who received a HVLA manipulation of the lumbar spine at least three months earlier;
  • will be excluded women older than 50 years, that don't will present a bone mineral density exam.

Sites / Locations

  • Universidade Federal do Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HVLA Manipulation

Sham Manipulation

Arm Description

Intervention Group who receives a high velocity and low amplitude (HVLA) lumbar manipulation. A manual procedure also known as high velocity and low amplitude lumbar spinal manipulation is delivered to the subjects in the side lying position. The more restricted lumbar segment (mobility restriction) will be the target region for the manipulative procedure.

Control Group who receives a simulated manipulation.

Outcomes

Primary Outcome Measures

pressure pain threshold assessment (algometer)
An algometer will used to assess the pressure pain threshold at baseline and following the intervention

Secondary Outcome Measures

Clinical Prediction Rule
Variables which encompass the clinical prediction rule: symptoms lower than 16 days, Fear Avoidance-Beliefs Questionnaire lower than 19 in the work subscale, segmental lumbar hypermobility test in prone decubitus, internal hip rotation higher than 35 degrees and symptoms that don't pass the knee.
Center of pressure displacement
A force platform will be used to measure the displacement of the center of pressure (COP) in the anterior-posterior direction at baseline and following the intervention
Subjective pain assessment
Visual-analogue scale will be used to obtain a subjective assessment of pain at baseline and following the intervention

Full Information

First Posted
November 28, 2014
Last Updated
May 21, 2015
Sponsor
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT02312778
Brief Title
Immediate Effects of a Spinal Lumbar Manipulation
Official Title
Immediate Effects of a Spinal Lumbar Manipulation on the Threshold Pressure Pain and the Postural Control in Subjects With Non-specific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Non-specific low back pain is defined as a pain with no specific vertebral-related cause, such as infectious disease, tumor, osteoporosis, fracture, structural abnormality, inflammatory disease, radicular compressive syndrome or cauda equine syndrome. Non-specific low back pain is a common disease in many countries. This musculoskeletal disorder is costly to public health systems. Therefore, the use of manual therapies is important in the treatment of this disease and studies show the effectiveness of this type of therapy. Spinal manipulation is applied in manual therapies such as Osteopathy, Chiropractic and Physical Therapy and is widely used for acute and chronic non-specific low-back pain. There is moderate evidence that spinal manipulation is superior to sham spinal manipulation for improving short-term pain and function in chronic and acute non-specific low back pain. However the therapeutic mechanisms involved in this procedure are not well understood. Furthermore, while the high velocity and low amplitude spinal therapy has been shown to be effective in reducing pain and improving functional capacity in subjects with non-specific low back pain, the effect on postural variables have not been investigated. Therefore, the aim of this study is to evaluate the acute effect of lumbar manipulation on pain and postural variables. Twenty-four individuals with non-specific low back pain will be randomly allocated to two groups. The intervention group will receive high velocity and low amplitude spinal therapy, while the control group will receive sham manipulation. Immediately before and after the respective manipulation protocol, both groups will be evaluated regarding pain level, using a visual-analogue scale and algometer, and postural variables, using center of pressure displacement measured with the aid of a force plate. While the patient and therapist manipulator will be aware of the protocol applied in each case, the evaluator will be blind. A statistical treatment will be used to compare the results.
Detailed Description
Mean and standard deviation are calculated for each variable of postural control, as well as the values obtained in the measurement of pain using the numeric pain rating scale and algometry data. t-test or Mann-Whitney test will be used to compare data before and after the manipulation protocol. Multiple One-Way ANOVAs will be used to compare the manipulation protocol, for each dependent variable: effects of pain and center of pressure displacement.. Statistical analysis will be conducted with a confidence interval of 95%, α value of 5%, p value of ≤ 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
non-specific low back pain, center of pressure, spinal lumbar manipulation, high velocity and low amplitude manipulation, postural control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HVLA Manipulation
Arm Type
Experimental
Arm Description
Intervention Group who receives a high velocity and low amplitude (HVLA) lumbar manipulation. A manual procedure also known as high velocity and low amplitude lumbar spinal manipulation is delivered to the subjects in the side lying position. The more restricted lumbar segment (mobility restriction) will be the target region for the manipulative procedure.
Arm Title
Sham Manipulation
Arm Type
No Intervention
Arm Description
Control Group who receives a simulated manipulation.
Intervention Type
Other
Intervention Name(s)
HVLA Manipulation
Intervention Description
Intervention Group who receives a high velocity and low amplitude (HVLA) lumbar manipulation. A manual procedure also known as high velocity and low amplitude lumbar spinal manipulation are delivered for the subjects in the side lying position. The lumbar segment more restrict (mobility restriction) will be the target region for the manipulative procedure.
Primary Outcome Measure Information:
Title
pressure pain threshold assessment (algometer)
Description
An algometer will used to assess the pressure pain threshold at baseline and following the intervention
Time Frame
Within one day
Secondary Outcome Measure Information:
Title
Clinical Prediction Rule
Description
Variables which encompass the clinical prediction rule: symptoms lower than 16 days, Fear Avoidance-Beliefs Questionnaire lower than 19 in the work subscale, segmental lumbar hypermobility test in prone decubitus, internal hip rotation higher than 35 degrees and symptoms that don't pass the knee.
Time Frame
Within one day
Title
Center of pressure displacement
Description
A force platform will be used to measure the displacement of the center of pressure (COP) in the anterior-posterior direction at baseline and following the intervention
Time Frame
Within one day
Title
Subjective pain assessment
Description
Visual-analogue scale will be used to obtain a subjective assessment of pain at baseline and following the intervention
Time Frame
Within one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: recurrent low back pain in the last three months; medical diagnosis of non-specific low back pain, daily or almost daily; subjects that will present at least four variables which encompass the clinical prediction rule: symptoms duration less than 16 days, Fear Avoidance-Beliefs Questionnaire score lower than 19 in the work subscale, segmental lumbar hypermobility test in prone decubitus, internal hip rotation higher than 35 degrees and symptoms that don't pass the knee. Exclusion Criteria: subjects presenting symptoms that pass the knee; impairment of neurologic signs like sensibility, muscle force and deep tendon reflex; a prior history of spondylolisthesis, spinal stenosis, inflammatory disease, cancer, musculoskeletal degenerative disease, pregnancy, disease and drugs that impairment the balance; subjects who received a HVLA manipulation of the lumbar spine at least three months earlier; will be excluded women older than 50 years, that don't will present a bone mineral density exam.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jefferson F Loss, Phd
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90690-200
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
32487243
Citation
Fagundes Loss J, de Souza da Silva L, Ferreira Miranda I, Groisman S, Santiago Wagner Neto E, Souza C, Tarrago Candotti C. Immediate effects of a lumbar spine manipulation on pain sensitivity and postural control in individuals with nonspecific low back pain: a randomized controlled trial. Chiropr Man Therap. 2020 Jun 3;28(1):25. doi: 10.1186/s12998-020-00316-7.
Results Reference
derived

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Immediate Effects of a Spinal Lumbar Manipulation

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