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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: Group 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation; Other: Group 2- Side-Lying Lumbar Spinal Manipulation

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Alanya
    • Antalya, Alanya, Turkey
      • Alanyaaku

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation; The posterior-anterior unilateral vertebral manipulation.	Other: Group 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; Other: Group 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.
Experimental: Group 2- Side-Lying Lumbar Spinal Manipulation; A high-speed, low-amplitude thrust force was applied in opposite directions: anteriorly to the pelvis and posteriorly to the shoulder	Other: Group 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; Other: Group 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modify shober test	Lumbal region flexion flexibility was measured by modified Schober Test.	The measurements were performed before and immediately after the applications.
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.

Collaborators and Investigators

• Sponsor: Alanya Alaaddin Keykubat University
• Investigators: Principal Investigator: Emine KURT, Assc. Prof., Alanya Alaaddin Keykubat University

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2021
• Primary Completion (Actual): September 20, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Low back pain; physiotherapy; Acute Manipulation; Chronic manipulation; muscles mechanical treshold
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 10354421-2021/03-14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No