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NCT Number: NCT05804357

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

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.

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Key information

Conditions

Intervertebral Disc Displacement Anxiety Disorders Behavior Behavioral Symptoms Bone Diseases Depression Hernia Kinesiophobia Lumbar Disc Herniation Mental Disorders Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Phobic Disorders Psychological Quality of Life Spinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muş Alparslan University

Muş, 49250, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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

Other names: Lumbal Spinal Mobilization

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.

Other names: Stabilization Exercise

Primary outcomes

  1. Pain Assessment

    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

    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 outcomes

  1. Anxiety and Depression Assessment

    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

    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.

  2. Kinesiophobia Assessment

    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

    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.

  3. Pain Catastrophizing Assessment

    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

    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.

  4. Quality of Life Assessment

    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

    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.

Sponsors and collaborators

Lead sponsor

Muş Alparslan University

Other

Registry information

Official study title

The Effect of Manual Therapy on Psychological Factors and Quality of Life in Lumbal Disc Herniation Patients: A Single Blind Randomized Clinical Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2023
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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