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Immediate Effects of Two Spinal Manipulative Techniques

Immediate Effects of Two Spinal Manipulative Techniques on Clinical Outcomes and Muscle Mechanical Properties in Chronic Low Back Pain: An Assessor Blinded, Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05057091
Enrollment
46
Registered
2021-09-27
Start date
2021-09-19
Completion date
2021-11-30
Last updated
2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low-back Pain

Keywords

Acute Manipulation, Chronic manipulation, Low back pain, muscles mechanical treshold, physiotherapy

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.

Interventions

OTHERGroup 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation

For the posterior-anterior unilateral vertebral manipulation, the therapist positioned both thumbs on top of each other on the spinous process of the vertebra and applied an average of 4 kg of discrete pressure

OTHERGroup 2- Side-Lying Lumbar Spinal Manipulation

The therapist stood in front of the patient, who was instructed to lie on their side with the painful side facing upward.the therapist utilized their arm and body to apply the manipulation. A high-speed, low-amplitude thrust force was applied in opposite directions: anteriorly to the pelvis and posteriorly to the shoulder.

Sponsors

Alanya Alaaddin Keykubat University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Intervention model description

This research is planned as a double blind randomized controlled trials

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mechanical properties measurementsthrough study completion, an average of 1 hourA 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

MeasureTime frameDescription
Oswestry low back pain scaleThrough study completion, an average of 1 hourit 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 scaleThrough study completion, an average of 1 hourThis 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 scaleThrough study completion, an average of 1 hourVAS 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 QuestionnareThrough study completion, an average of 1 hourFear 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.

Other

MeasureTime frameDescription
Modify shober testThe measurements were performed before and immediately after the applications.Lumbal region flexion flexibility was measured by modified Schober Test.
Sit and reach tetsThe measurements were performed before and immediately after the applications.Lumbar region extansors flexibilty test was measured by sit and reach test

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026