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Affects of Different Vertebral Manipulation Techniques on Chronic Low Back Pain

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lomber roll techniques group (n=23)
Posterior- anterior central vertebral manipulation techniques (n=23)
Sponsored by
Alanya Alaaddin Keykubat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Acute Manipulation, Chronic manipulation, Low back pain, muscles mechanical treshold, physiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-65 ages
  • Individuals with non-specific chronic low back pain who have continued pain for at least 3 months
  • According to VAS, individuals with pain of at least 3 severity

Exclusion Criteria:

  • Pregnancy situation or suspicion
  • Spinal Stenosis
  • Vertebral fracture
  • Cancer
  • Osteoporosis
  • Individuals with BMI over 30 kg/m2
  • Those with neurological disease that leads to November loss of muscle strength or spasticity-rigidity

Sites / Locations

  • Alanyaaku

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lomber Roll techniques group

Posterior- anterior central vertebral manipulation techniques group

Arm Description

Direct manipulation will be applied to the lumbar region with the lumbar Roll technique. Painful segment will be determined.

Another technique that we will use as a specific vertebral manipulation technique will be Maitland's posterior-anterior central vertebral manipulation and posterior - anterior unilateral central vertebral mobilization technique.

Outcomes

Primary Outcome Measures

Mechanical properties measurements
A MyotonPro was used to measure the mechanical properties of selected muscles. the measurements of the medial gastrocnemius and biceps femoris muscles were performed while individuals were in prone position the knees at full extension, and the ankle at neural position. The measurements of medial gastrocnemius were performed on plumped portion of the muscle at a point 70% of the lower leg length in line with the popliteal crease to the lateral malleolus. For biceps femoris muscle, measurements were performed at the middle points between tuberosity of the ischium and the head of the fibula.the mechanical properties of lumbar extensor muscle were performed while the individuals were prone position the hip and knee at full extension. For lumbar extensor muscle, the measurements were performed at the point 3 cm from the midpoint of the L3/L4 intervertebral space. The average of three consecutive measurements was recorded.

Secondary Outcome Measures

Oswestry low back pain scale
it measures a total of 10 different aspects, severity of pain, personal care, lifting, walking, sitting, standing, sleeping, degree of pain change, social life, travel to assess the effect of low back pain on daily life activities in the patient.
Roland morris disability scale
This questionnaire is a 24-point questionnaire designed to assess the degree of functional limitation in patients with low back pain. In the survey, the answers vary from yes to no yes: 1 point, no: 0 points, and high scores indicate severe obstacle status
Visual analog scale
VAS was used to measure the severity of the patient's pain. It is usually 10 cm long, horizontal or vertical; it is a line that begins with "no pain" and ends with "unbearable pain". This line can only be a straight line, or divided into equal December, or in pain definition, the definition placed on the line can be found in words. The patient indicates the severity of his pain with a sign where he sees fit on this line. "Cm" was measured and recorded between the point marked with the onset of decontamination. "0 'means no pain,' 5 'means moderate pain,' 10" means the most severe pain encountered in life.
Fear Avoidance Beliefs Questionnare
Fear avoidance beliefs questionnare has 16 questions and two sub-scales, physical activity and work. The physical activity section consists of 5 questions, and the work section consists of 11 questions. The survey was a Likert-type scale of 7. In the answers given to the survey, the expression I disagree with at all is given 0 points and the expression I fully agree with is given 6 points.

Full Information

First Posted
September 6, 2021
Last Updated
July 24, 2023
Sponsor
Alanya Alaaddin Keykubat University
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1. Study Identification

Unique Protocol Identification Number
NCT05057091
Brief Title
Affects of Different Vertebral Manipulation Techniques on Chronic Low Back Pain
Official Title
Investigation Of The Effects Of Direct And İndirect Vertebral Manipulation Techniques On Clinical Parameters And Muscle Mechanical Properties İn Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alanya Alaaddin Keykubat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to investigate the instant effects of direct vertabral manipulation and indirect vertebral manipulation techniques on muscles mechanical properties, pressure-pain threshold and joint range of motion in individuals with chronic low back pain. Another purpose of this study was to compare the effects of both treatment methods on the parameters studied.
Detailed Description
Resolving chronic low back pain is a costly obstacle. There is a wide spectrum of treatment for chronic low back pain, such as exercise training, pain training and spinal manipulation.It is the recommended spinal manipulation in the short and long term in chronic low back pain. Clinical Spinal manipulation is one of the most preferred methods of reducing pain and disability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Acute Manipulation, Chronic manipulation, Low back pain, muscles mechanical treshold, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This research is planned as a double blind randomized controlled trials
Masking
None (Open Label)
Masking Description
A power analysis was conducted to determine the number of cases to be included in the study. In order for the study to be performed at 80% strength and with a 5% margin of error, at least 23 people from each group should be included in the study to find a difference of 30 N/m after application, in the case where the lumbal extensor November hardness is 320 N/m and the standard deviation is 74 N/m
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lomber Roll techniques group
Arm Type
Experimental
Arm Description
Direct manipulation will be applied to the lumbar region with the lumbar Roll technique. Painful segment will be determined.
Arm Title
Posterior- anterior central vertebral manipulation techniques group
Arm Type
Experimental
Arm Description
Another technique that we will use as a specific vertebral manipulation technique will be Maitland's posterior-anterior central vertebral manipulation and posterior - anterior unilateral central vertebral mobilization technique.
Intervention Type
Other
Intervention Name(s)
Lomber roll techniques group (n=23)
Intervention Description
Direct manipulation will be applied to the lumbar region with the lumbar Roll technique. Painful segment will be determined.
Intervention Type
Other
Intervention Name(s)
Posterior- anterior central vertebral manipulation techniques (n=23)
Intervention Description
After initial assessments were made, both groups had high velocity and low amplitude (HVLA) or V. Level manipulation will be applied in the form of 2 different direct manipulation techniques
Primary Outcome Measure Information:
Title
Mechanical properties measurements
Description
A MyotonPro was used to measure the mechanical properties of selected muscles. the measurements of the medial gastrocnemius and biceps femoris muscles were performed while individuals were in prone position the knees at full extension, and the ankle at neural position. The measurements of medial gastrocnemius were performed on plumped portion of the muscle at a point 70% of the lower leg length in line with the popliteal crease to the lateral malleolus. For biceps femoris muscle, measurements were performed at the middle points between tuberosity of the ischium and the head of the fibula.the mechanical properties of lumbar extensor muscle were performed while the individuals were prone position the hip and knee at full extension. For lumbar extensor muscle, the measurements were performed at the point 3 cm from the midpoint of the L3/L4 intervertebral space. The average of three consecutive measurements was recorded.
Time Frame
through study completion, an average of 1 hour
Secondary Outcome Measure Information:
Title
Oswestry low back pain scale
Description
it measures a total of 10 different aspects, severity of pain, personal care, lifting, walking, sitting, standing, sleeping, degree of pain change, social life, travel to assess the effect of low back pain on daily life activities in the patient.
Time Frame
Through study completion, an average of 1 hour
Title
Roland morris disability scale
Description
This questionnaire is a 24-point questionnaire designed to assess the degree of functional limitation in patients with low back pain. In the survey, the answers vary from yes to no yes: 1 point, no: 0 points, and high scores indicate severe obstacle status
Time Frame
Through study completion, an average of 1 hour
Title
Visual analog scale
Description
VAS was used to measure the severity of the patient's pain. It is usually 10 cm long, horizontal or vertical; it is a line that begins with "no pain" and ends with "unbearable pain". This line can only be a straight line, or divided into equal December, or in pain definition, the definition placed on the line can be found in words. The patient indicates the severity of his pain with a sign where he sees fit on this line. "Cm" was measured and recorded between the point marked with the onset of decontamination. "0 'means no pain,' 5 'means moderate pain,' 10" means the most severe pain encountered in life.
Time Frame
Through study completion, an average of 1 hour
Title
Fear Avoidance Beliefs Questionnare
Description
Fear avoidance beliefs questionnare has 16 questions and two sub-scales, physical activity and work. The physical activity section consists of 5 questions, and the work section consists of 11 questions. The survey was a Likert-type scale of 7. In the answers given to the survey, the expression I disagree with at all is given 0 points and the expression I fully agree with is given 6 points.
Time Frame
Through study completion, an average of 1 hour
Other Pre-specified Outcome Measures:
Title
Modify shober test
Description
Lumbal region flexion flexibility was measured by modified Schober Test.
Time Frame
The measurements were performed before and immediately after the applications.
Title
Sit and reach tets
Description
Lumbar region extansors flexibilty test was measured by sit and reach test
Time Frame
The measurements were performed before and immediately after the applications.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 ages Individuals with non-specific chronic low back pain who have continued pain for at least 3 months According to VAS, individuals with pain of at least 3 severity Exclusion Criteria: Pregnancy situation or suspicion Spinal Stenosis Vertebral fracture Cancer Osteoporosis Individuals with BMI over 30 kg/m2 Those with neurological disease that leads to November loss of muscle strength or spasticity-rigidity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine KURT, Assc. Prof.
Organizational Affiliation
Alanya Alaaddin Keykubat University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alanyaaku
City
Antalya
State/Province
Alanya
Country
Turkey

12. IPD Sharing Statement

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Affects of Different Vertebral Manipulation Techniques on Chronic Low Back Pain

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