The Effect of Manual Therapy on Psychological Factors and Quality of Life in Lumbal Disc Herniation Patients

NCT ID: NCT05804357

Last Updated: 2023-04-07

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2022-07-25

Brief Summary

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When the literature is examined, there are studies examining the relationship between low back pain and anxiety depression, quality of life and LDH in patients with lumbar disc herniation. There are many studies on the clinical use of manual therapy methods in LDH. Most of these studies examine the effect of manual therapy on pain and functional level. However, there are hardly any studies examining the effect of manual therapy on quality of life and psychological factors in LDH patients.

The aim of our study is to examine the effect of mobilization, which is a manual therapy application, on psychological factors (kinesiophobia, pain catastrophic thought, anxiety and depression) and quality of life in LDH patients.

Detailed Description

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There are various treatment options that can be applied to patients with lumbar disc herniation (LDH). These are basically divided into 2 categories: surgical and conservative treatment. Conservative treatment methods in the treatment of LDH aim to prevent the disease from transitioning to interventional methods and / or surgical treatment and to improve the complaints that negatively affect the quality of life. Conservative treatment; It includes informing the patient, bed rest, drug treatments, exercise, thermotherapy, electrotherapy, traction, orthoses, back school and manual therapy applications. Manual therapy; It is used to reduce pain, provide joint and tissue mobility, inhibit sympathetic reflex activity, normalize muscle tone and dissolve adhesions. Manual therapy is the manual treatment of the spine with two different applications such as manipulation and mobilization.

The clinical effects of manual therapy in LDH patients were examined. The aim of this study was to investigate the effect of manual therapy on psychological factors and quality of life in patients with lumbar disc herniation.

Conditions

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Intervertebral Disc Displacement Lumbar Disc Herniation Psychological Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study was designed as a double-blind randomized controlled clinical trial. In order to carry out the prospectively designed study, ethics committee approval was obtained from the Non-Interventional Clinical Research Ethics Committee of Muş Alparslan University with the decision numbered 21 taken at the meeting dated 29.12.2020 and numbered 15. Informed consent was obtained from all patients included in the study before the study.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Eligible patients were divided into two groups using the closed envelope method at a ratio of 1:1. The patients did not know which group they were in. Mobilization applications and other clinical tests were performed by the same physiotherapist in the study.

Study Groups

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Exercise Group

In our study, stabilization exercises were applied to the patients in the exercise group. The treatment was applied two days a week for five weeks, for a total of ten sessions. After the end of the treatment, stabilization exercises were recommended as a home exercise program until the follow-up evaluation at the third month. A telephone connection was established with the patients once a week and the home program was followed up.Stabilization exercises: It is an approach that is combined with diaphragmatic breathing and activates the passive. The stabilization exercise program was applied in three phases and was progressed in line with the developments in the patients

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

It is an approach that is combined with diaphragmatic breathing, activating the passive-active musculoskeletal and neural systems. In this approach, transversus abdominis and multifudus muscles are activated as deep core muscles.

Manual Therapy Group

In our study, stabilization exercises and spinal mobilization practices were performed to the patients in the manual therapy group. The treatment was applied two days a week for five weeks, for a total of ten sessions. After the end of the treatment, stabilization exercises were recommended as a home exercise program until the follow-up evaluation at the third month. A telephone connection was established with the patients once a week and the home program was followed up.Mobilization applications were applied at Maitland IV degree as standard.Three mobilization methods were applied Anterior-Posterior Lumbal Spinal Mobilization Lumbal Spinal Rotational Mobilization Joint Mobilization in Lumbal Flexion Position

Group Type EXPERIMENTAL

Manual Therapy

Intervention Type BEHAVIORAL

Mobilization applications are passive movements that do not involve pushing or stimuli, applied within the range of motion or up to the physiological range of motion

Interventions

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Manual Therapy

Mobilization applications are passive movements that do not involve pushing or stimuli, applied within the range of motion or up to the physiological range of motion

Intervention Type BEHAVIORAL

Exercise

It is an approach that is combined with diaphragmatic breathing, activating the passive-active musculoskeletal and neural systems. In this approach, transversus abdominis and multifudus muscles are activated as deep core muscles.

Intervention Type BEHAVIORAL

Other Intervention Names

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Lumbal Spinal Mobilization Stabilization Exercise

Eligibility Criteria

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Inclusion Criteria

* It was determined as being diagnosed with LDH by MR by a physical therapy physician
* Having pain of at least 3 levels or more according to the Visual Analogue Scale
* Being between the ages of 18-65.

Exclusion Criteria

* History of spinal surgery
* History of autoimmune disease (ankylosing spondylitis, rheumatoid arthritis or other)
* Spondylolysis and spondylolisthesis
* Spinal fracture
* Heart pathology
* History of stroke,
* Cauda equina syndrome
* Continuous use of pain medication
* Spinal inflammation,
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Muş Alparslan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Burhan Taşkaya

Role: PRINCIPAL_INVESTIGATOR

Muş Alparslan University

Locations

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Muş Alparslan University

Muş, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Taskaya B, Taskent I, Cakilli M, Yilmaz O. The Effect of Manual Therapy on Psychological Factors and Quality of Life in Lumbar Disc Herniation Patients: A Single Blinded Randomized Clinical Trial. Int J Environ Res Public Health. 2024 Sep 18;21(9):1234. doi: 10.3390/ijerph21091234.

Reference Type DERIVED
PMID: 39338117 (View on PubMed)

Other Identifiers

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E-10879717-016.18.22

Identifier Type: -

Identifier Source: org_study_id

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