Quality of Life Clinical Trial
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
Verified date | March 2023 |
Source | Mus Alparlan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | July 25, 2022 |
Est. primary completion date | April 25, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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, |
Country | Name | City | State |
---|---|---|---|
Turkey | Mus Alparslan University | Mus |
Lead Sponsor | Collaborator |
---|---|
Mus Alparlan University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 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 | |
Secondary | 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. | 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 | |
Secondary | 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. | The change of pain catastrophe assessed before treatment, through treatment completion, an average of 1 week and during follow-up 3 months after treatment | |
Secondary | 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. | 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 |
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