Clinical trial NCT05804357: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intervertebral Disc Displacement
Lumbar Disc Herniation
Psychological
Quality of Life
Keywords: Lumbar disc herniation
Manual therapy
Kinesiophobia
Anxiety and depression
Pain catastrophe
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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,

Primary outcomes:
measure: Pain Assessment
timeFrame: 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:
measure: Anxiety and Depression Assessment
timeFrame: 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
measure: Kinesiophobia Assessment
timeFrame: 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
measure: Pain Catastrophizing Assessment
timeFrame: The change of pain catastrophe assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment
measure: Quality of Life Assessment
timeFrame: 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
Other outcomes:
Locations:
city: Muş
country: Turkey
facility: Muş Alparslan University
Study officials:
affiliation: Muş Alparslan University
name: Burhan Taşkaya
role: PRINCIPAL_INVESTIGATOR
References: