The Effect of Manual Lymph Drainage in Fibromyalgia Patients
Manual Lymph Drainage in Fibromyalgia Patients; Oxidative Stress, Pain, Functional Effect on Mood and Sleep Quality
Sponsor study identifier
interventional
44
1 country
1
Study Start
December 27, 2023
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 27, 2023
Actual (reported)August 5, 2024
Actual (reported)August 26, 2024
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
oxidative stress and other biochemical analyzes
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.Blood samples will be taken from the patients before, after and one month after the end of treatment and Paraoxonase (PON1), Oxidative Stress Index (OSI), malondialdehyde (MDA), Rductegulutathione (GSH), Low danditelilipoprotein (LDL), High danditelilipoprotein (HDL) and Triglyceride levels will be evaluated.
Both groups will be evaluated before treatment, immediately after treatment and one month after treatment.
Pain evaluation of
Both groups will be evaluated before treatment, immediately after treatment and one month after treatment.
Functional Status evaluation of
Both groups will be evaluated before treatment, immediately after treatment and one month after treatment.
Sleep quality evaluation of
Both groups will be evaluated before treatment, immediately after treatment and one month after treatment.
Conservative treatment will be applied to the back-neck region. In this treatment, 20 min hotpack, 10 min ultrasound agent (frequency 0.5-3.5MHz), 20 min Transcutaneous Electrical Nerve Stimulation (TENS) agent (Conventional TENS; Frequency 60-80 Hz, current passage time 50-100 microseconds) will be given. 15 sessions will be applied. Unlike the control group, manual lymph drainage treatment, the effect of which is aimed to be investigated, will be applied to the study group. Manual lymph drainage treatment will be performed by a lymphedema physiotherapist trained in Manual Lymph Drainage / Complex Unloading Physiotherapy.
Conservative treatment will be applied to the back-neck region. In this treatment, 20 min hotpack, 10 min ultrasound agent (frequency 0.5-3.5MHz), 20 min Transcutaneous Electrical Nerve Stimulation (TENS) agent (Conventional TENS; Frequency 60-80 Hz, current passage time 50-100 microseconds) will be given. 15 sessions will be applied.
Conservative treatment will be applied to the back-neck region in both groups. In this treatment, 20 min hotpack, 10 min ultrasound agent (frequency 0.5-3.5MHz), 20 min Transcutaneous Electrical Nerve Stimulation (TENS) agent (Conventional TENS; Frequency 60-80 Hz, current passage time 50-100 microseconds) will be given.
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Baskent University
Adana, çukurova, 01250, Turkey (Türkiye)
Heidari F, Afshari M, Moosazadeh M. Prevalence of fibromyalgia in general population and patients, a systematic review and meta-analysis. Rheumatol Int. 2017 Sep;37(9):1527-1539. doi: 10.1007/s00296-017-3725-2. Epub 2017 Apr 26.
Bennett RM, Friend R, Marcus D, Bernstein C, Han BK, Yachoui R, Deodhar A, Kaell A, Bonafede P, Chino A, Jones KD. Criteria for the diagnosis of fibromyalgia: validation of the modified 2010 preliminary American College of Rheumatology criteria and the development of alternative criteria. Arthritis Care Res (Hoboken). 2014 Sep;66(9):1364-73. doi: 10.1002/acr.22301.
Selen OZGOZEN, Dr
dr
First Submitted
August 5, 2024
First Posted
August 26, 2024
Study Start
December 27, 2023
Actual (reported)Primary Completion
Influence of Painphysiolgy Education on the Pain Inhibition in Fibromyalgia
Contact the study team to confirm eligibility.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 23, 2024
Record last verified: 2024-08
The evaluator and the researcher working on the antioxidant panel will be blinded.
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