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Completed

NCT Number: NCT05057091

Immediate Effects of Two Spinal Manipulative Techniques

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alanyaaku

Antalya, Alanya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Group 2- Side-Lying Lumbar Spinal Manipulation

Other

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.

Primary outcomes

  1. Mechanical properties measurements

    Time frame: through study completion, an average of 1 hour

    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 outcomes

  1. Oswestry low back pain scale

    Time frame: Through study completion, an average of 1 hour

    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.

  2. Roland morris disability scale

    Time frame: Through study completion, an average of 1 hour

    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

  3. Visual analog scale

    Time frame: Through study completion, an average of 1 hour

    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.

  4. Fear Avoidance Beliefs Questionnare

    Time frame: Through study completion, an average of 1 hour

    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.

Other outcomes

  1. Modify shober test

    Time frame: The measurements were performed before and immediately after the applications.

    Lumbal region flexion flexibility was measured by modified Schober Test.

  2. Sit and reach tets

    Time frame: The measurements were performed before and immediately after the applications.

    Lumbar region extansors flexibilty test was measured by sit and reach test

Sponsors and collaborators

Lead sponsor

Alanya Alaaddin Keykubat University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 27, 2021
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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