Affects of Different Vertebral Manipulation Techniques on Chronic Low Back Pain

Chronic Low-back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05057091
• Other study ID #: 10354421-2021/03-14
• Status: Completed
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: July 2023
• Source: Alanya Alaaddin Keykubat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 30, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Lomber roll techniques group (n=23)
Direct manipulation will be applied to the lumbar region with the lumbar Roll technique. Painful segment will be determined.
• Posterior- anterior central vertebral manipulation techniques (n=23)
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

Locations

Country	Name	City	State
Turkey	Alanyaaku	Antalya	Alanya

Sponsors (1)

Lead Sponsor	Collaborator
Alanya Alaaddin Keykubat University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Modify shober test	Lumbal region flexion flexibility was measured by modified Schober Test.	The measurements were performed before and immediately after the applications.
Other	Sit and reach tets	Lumbar region extansors flexibilty test was measured by sit and reach test	The measurements were performed before and immediately after the applications.
Primary	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.	through study completion, an average of 1 hour
Secondary	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.	Through study completion, an average of 1 hour
Secondary	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	Through study completion, an average of 1 hour
Secondary	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.	Through study completion, an average of 1 hour
Secondary	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.	Through study completion, an average of 1 hour