Clinical trial

Manual Lymph Drainage in Fibromyalgia Patients; Oxidative Stress, Pain, Functional Effect on Mood and Sleep Quality

Aliases
NCT06571565, PDANALAN
Name
PDANALAN
Description
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.
Trial arms
Trial start
2023-12-27
Estimated PCD
2025-12-31
Trial end
2026-12-31
Phase
Early phase I
Treatment
conservative treatment
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.
Arms:
control group, working group
Size
44
Primary endpoint
oxidative stress and other biochemical analyzes
Both groups will be evaluated before treatment, immediately after treatment and one month after treatment.
Eligibility criteria
Inclusion Criteria: * Female patients aged 25 years and older who have been admitted to the Physical Therapy and Rehabilitation clinic for the treatment of fibromyalgia syndrome, who have been diagnosed with FMS for at least 2 years and whose medication use level for FMS treatment has been stable for at least 3 months will be included. Exclusion Criteria: * The exclusion criteria were determined as follows: Patients with concomitant decompensated and/or acute cardiovascular disease, scar tissue that disrupts the integrity of the skin in the area of application (back-neck), use of psychiatric medication (recently started or ongoing psychiatric medical treatment for less than 3 months, antipsychotic treatment that has not yet reached the therapeutic dose), acute infection of bacterial or viral origin. In addition, people with uncontrolled additional rheumatologic diseases that may affect the patient's pain, sleep, functional status and anti-oxidant biochemical parameters, and people with endocrinometabolic diseases such as hypothyroidism, which may change the soft tissue structure in the treatment area and cause edema, will be excluded from the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'As a randomized controlled single blind', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The evaluator and the researcher working on the antioxidant panel will be blinded.', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 44, 'type': 'ESTIMATED'}}
Updated at
2024-09-23

1 organization

1 product

2 indications

Organization
Baskent University
Indication
Fibromyalgia