Immediate Effects of Two Spinal Manipulative Techniques

NCT ID: NCT05057091

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-19

Study Completion Date

2021-11-30

Brief Summary

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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

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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.

Conditions

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Chronic Low-back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This research is planned as a double blind randomized controlled trials
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Study Groups

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

The posterior-anterior unilateral vertebral manipulation.

Group Type EXPERIMENTAL

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

Intervention Type 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

Intervention Type 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 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

Group Type EXPERIMENTAL

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

Intervention Type 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

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alanya Alaaddin Keykubat University

OTHER

Sponsor Role lead

Responsible Party

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Ayça Araci

pHd., Clinical Physiotherapist, Principal invetsigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emine KURT, Assc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Alanya Alaaddin Keykubat University

Locations

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Alanyaaku

Antalya, Alanya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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10354421-2021/03-14

Identifier Type: -

Identifier Source: org_study_id

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