Immediate Effects of Two Spinal Manipulative Techniques

NCT05057091 | Completed

• 1 other identifier: 10354421-2021/03-14
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Oswestry low back pain scale

  Through study completion, an average of 1 hour

• Roland morris disability scale

  Through study completion, an average of 1 hour

• Visual analog scale

  Through study completion, an average of 1 hour

• Fear Avoidance Beliefs Questionnare

  Through study completion, an average of 1 hour

Other Outcomes (2)

• Modify shober test

  The measurements were performed before and immediately after the applications.

• Sit and reach tets

  The measurements were performed before and immediately after the applications.

Study Arms (2)

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

EXPERIMENTAL

The posterior-anterior unilateral vertebral manipulation.

Other: Group 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation; Other: Group 2- Side-Lying Lumbar Spinal Manipulation

Group 2- Side-Lying Lumbar Spinal Manipulation

EXPERIMENTAL

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; Other: Group 2- Side-Lying Lumbar Spinal Manipulation

Interventions

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 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation; Group 2- Side-Lying Lumbar Spinal Manipulation

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.

Group 1 - Maitland's Posterior-Anterior Central Vertebral Manipulation; Group 2- Side-Lying Lumbar Spinal Manipulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alanya Alaaddin Keykubat University: lead

Study Sites (1)

Alanyaaku

Antalya, Alanya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emine KURT, Assc. Prof.

  Alanya Alaaddin Keykubat University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pHd., Clinical Physiotherapist, Principal invetsigator

Model Details: This research is planned as a double blind randomized controlled trials

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 27, 2021
• Study Start: September 19, 2021
• Primary Completion: September 20, 2021
• Study Completion: November 30, 2021
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

TU (1)