Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571565
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
The Effect of Manual Lymph Drainage in Fibromyalgia Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Manual Lymph Drainage in Fibromyalgia Patients Oxidative Stress Pain Functional Effect on Mood and Sleep Quality
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this randomized controlled single blinded study our primary objective is to evaluate the effects of manual lymphatic drainage on blood lipid peroxidation system and antioxidant system in FMS patients For this objective the following biochemical analyses will be performed to objectively evaluate the effect of manual lymphatic drainage
Our secondary objective is to evaluate the changes in pain functional status and sleep quality with manual lymphatic drainage treatment The evaluator and the investigator working on the antioxidant panel will be blinded
Our secondary objective is to evaluate the changes in pain functional status and sleep quality with manual lymphatic drainage treatment The evaluator and the investigator working on the antioxidant panel will be blinded
Detailed Description:
Fibromyalgia syndrome FMS is a chronic musculoskeletal disorder with poorly understood pathophysiology and etiology characterized by tender points in specific anatomical regions often accompanied by fatigue cognitive impairment psychiatric symptoms sleep disturbances and multiple somatic symptoms FMS is a difficult disease to treat and may require the use of multifaceted treatment modalities The main goal of treatment is to reduce pain regulate sleep and improve physical function There are different results in studies investigating the effectiveness of treatment modalities in FMS and there is no standardization in the methodology of these studies In randomized controlled trials and systematic reviews there is moderate evidence that massage improves sleep quality and reduces anxiety In the literature lymph drainage has been applied to these patients as a treatment method and there is limited evidence that it reduces pain
In this randomized controlled single blinded study our primary objective was to evaluate the effects of manual lymphatic drainage on blood lipid peroxidation system and antioxidant system in FMS patients For this objective the following biochemical analyses will be performed to objectively evaluate the effect of manual lymphatic drainage
Our secondary objective is to evaluate the changes in pain functional status and sleep quality with manual lymphatic drainage treatment The evaluator and the researcher working on the antioxidant panel will be blinded The study will include female patients aged 25 years and older who have been diagnosed with FMS for at least 2 years and whose level of medication use for FMS treatment has been stable for at least 3 months who apply to Başkent University Adana Research and Application Center Physical Therapy and Rehabilitation clinic for fibromyalgia syndrome treatment
Patients will be evaluated in terms of pain intensity sleep functional status and quality of life as well as oxidative stress and antioxidant levels in three stages before treatment immediately after treatment and one month after the end of treatment Blood samples will be taken before treatment immediately after treatment and one month after treatment for the evaluation of oxidative stress and antioxidant levels Paraoxonase PON1 Oxidative Stress Index OSI Malondialdehyde MDA Reduced Glutathione GSH Low Density Lipoprotein LDL High Density Lipoprotein HDL and Triglyceride levels will be analyzed in these blood samples
In this randomized controlled single blinded study our primary objective was to evaluate the effects of manual lymphatic drainage on blood lipid peroxidation system and antioxidant system in FMS patients For this objective the following biochemical analyses will be performed to objectively evaluate the effect of manual lymphatic drainage
Our secondary objective is to evaluate the changes in pain functional status and sleep quality with manual lymphatic drainage treatment The evaluator and the researcher working on the antioxidant panel will be blinded The study will include female patients aged 25 years and older who have been diagnosed with FMS for at least 2 years and whose level of medication use for FMS treatment has been stable for at least 3 months who apply to Başkent University Adana Research and Application Center Physical Therapy and Rehabilitation clinic for fibromyalgia syndrome treatment
Patients will be evaluated in terms of pain intensity sleep functional status and quality of life as well as oxidative stress and antioxidant levels in three stages before treatment immediately after treatment and one month after the end of treatment Blood samples will be taken before treatment immediately after treatment and one month after treatment for the evaluation of oxidative stress and antioxidant levels Paraoxonase PON1 Oxidative Stress Index OSI Malondialdehyde MDA Reduced Glutathione GSH Low Density Lipoprotein LDL High Density Lipoprotein HDL and Triglyceride levels will be analyzed in these blood samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None