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

Primary Purpose

Intervertebral Disc Displacement, Lumbar Disc Herniation, Psychological

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual Therapy
Exercise
Sponsored by
Muş Alparlan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intervertebral Disc Displacement focused on measuring Lumbar disc herniation, Manual therapy, Kinesiophobia, Anxiety and depression, Pain catastrophe

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

  • Muş Alparslan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Exercise Group

Manual Therapy Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain Assessment
McGill-Melzack Pain Questionnaire :It is a questionnaire applied to determine the location, characteristics, relationship with time and severity of low back pain. The total score is obtained by summing the points corresponding to the answer given according to each category. While the maximum score was 78, the minimum score was set to 0. The higher the pain, the higher the score.

Secondary Outcome Measures

Anxiety and Depression Assessment
Hospital Anxiety and Depression Scale :It is a self-assessment scale applied to determine the risk of anxiety and depression in the patient, to measure its level and change in severity. It contains a total of 14 questions, seven of which measure anxiety and the other seven measure depression.
Kinesiophobia Assessment
Tampa Kinesiophobia Scale :Consisting of 17 questions, the scale measures individuals' fear of re-injury with movement. The questions in the scale are calculated with the Likert scoring type consisting of 4 points. Patients are given a minimum score of 17 and a maximum score of 68. The high score obtained as a result of the scale indicates the high degree of kinesiophobia. In studies, 37 points and above are defined as high kinesiophobia.
Pain Catastrophizing Assessment
Pain Catastrophizing Scale: It reliably assesses certain variables, such as fears, feelings or thoughts, severe pain, disability, and emotional disturbances associated with individuals' past pain experiences. The scale consists of 13 questions scored between 0-4 (0=Never, 1=A little. 2=Moderately, 3=Seriously, 4=Always). An increase in the scale score indicates a high fear of experiencing pain.
Quality of Life Assessment
Nottingham Health Profile (NHP): It is a valid-reliable quality of life scale used to evaluate the physical, emotional and social effects of diseases on individuals. It consists of six sections, including pain, physical activity, energy, sleep, social isolation and emotional reaction, and a total of 38 questions.

Full Information

First Posted
March 27, 2023
Last Updated
March 27, 2023
Sponsor
Muş Alparlan University
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1. Study Identification

Unique Protocol Identification Number
NCT05804357
Brief Title
The Effect of Manual Therapy on Psychological Factors and Quality of Life in Lumbal Disc Herniation Patients
Official Title
The Effect of Manual Therapy on Psychological Factors and Quality of Life in Lumbal Disc Herniation Patients: A Single Blind Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
July 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Muş Alparlan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disc Displacement, Lumbar Disc Herniation, Psychological, Quality of Life
Keywords
Lumbar disc herniation, Manual therapy, Kinesiophobia, Anxiety and depression, Pain catastrophe

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Manual Therapy Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Manual Therapy
Other Intervention Name(s)
Lumbal Spinal Mobilization
Intervention Description
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
Intervention Name(s)
Exercise
Other Intervention Name(s)
Stabilization Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Assessment
Description
McGill-Melzack Pain Questionnaire :It is a questionnaire applied to determine the location, characteristics, relationship with time and severity of low back pain. The total score is obtained by summing the points corresponding to the answer given according to each category. While the maximum score was 78, the minimum score was set to 0. The higher the pain, the higher the score.
Time Frame
The change of pain assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
Secondary Outcome Measure Information:
Title
Anxiety and Depression Assessment
Description
Hospital Anxiety and Depression Scale :It is a self-assessment scale applied to determine the risk of anxiety and depression in the patient, to measure its level and change in severity. It contains a total of 14 questions, seven of which measure anxiety and the other seven measure depression.
Time Frame
The change of anxiety and depression assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
Title
Kinesiophobia Assessment
Description
Tampa Kinesiophobia Scale :Consisting of 17 questions, the scale measures individuals' fear of re-injury with movement. The questions in the scale are calculated with the Likert scoring type consisting of 4 points. Patients are given a minimum score of 17 and a maximum score of 68. The high score obtained as a result of the scale indicates the high degree of kinesiophobia. In studies, 37 points and above are defined as high kinesiophobia.
Time Frame
The change of anxiety and depression assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
Title
Pain Catastrophizing Assessment
Description
Pain Catastrophizing Scale: It reliably assesses certain variables, such as fears, feelings or thoughts, severe pain, disability, and emotional disturbances associated with individuals' past pain experiences. The scale consists of 13 questions scored between 0-4 (0=Never, 1=A little. 2=Moderately, 3=Seriously, 4=Always). An increase in the scale score indicates a high fear of experiencing pain.
Time Frame
The change of pain catastrophe assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
Title
Quality of Life Assessment
Description
Nottingham Health Profile (NHP): It is a valid-reliable quality of life scale used to evaluate the physical, emotional and social effects of diseases on individuals. It consists of six sections, including pain, physical activity, energy, sleep, social isolation and emotional reaction, and a total of 38 questions.
Time Frame
The change of quality of life assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burhan Taşkaya
Organizational Affiliation
Muş Alparslan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muş Alparslan University
City
Muş
ZIP/Postal Code
49250
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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