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

NCT05804357 | Completed

• 1 other identifier: E-10879717-016.18.22
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Intervertebral Disc Displacement; Lumbar Disc Herniation; Psychological; Quality of Life

Keywords

Lumbar disc herniation; Manual therapy; Kinesiophobia; Anxiety and depression; Pain catastrophe

Outcome Measures

Primary Outcomes (1)

• 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.

  The change of pain assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment

Secondary Outcomes (4)

• Anxiety and Depression Assessment

  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

• Kinesiophobia Assessment

  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

• Pain Catastrophizing Assessment

  The change of pain catastrophe assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment

• Quality of Life Assessment

  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

Study Arms (2)

Exercise Group

ACTIVE COMPARATOR

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

Behavioral: Exercise

Manual Therapy Group

EXPERIMENTAL

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

Behavioral: Manual Therapy

Interventions

Manual Therapy 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

Also known as: Lumbal Spinal Mobilization

Manual Therapy Group

Exercise 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.

Also known as: Stabilization Exercise

Exercise Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Muş Alparslan University: lead

Study Sites (1)

Muş Alparslan University

Muş, 49250, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39338117 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement; Kinesiophobia; Anxiety Disorders; Depression

Interventions

Musculoskeletal Manipulations; Exercise

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Burhan Taşkaya

  Muş Alparslan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: January 15, 2021
• Primary Completion: April 25, 2022
• Study Completion: July 25, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)