The Effect of Manual Lymph Drainage in Fibromyalgia Patients

NCT06571565 | Enrolling By Invitation Early Phase 1 DMC

• 1 other identifier: PDANALAN
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Oxidative Stress

Keywords

Fibromyalgia; manual lymph drainage; lymph; oxidative stress

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• 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.

Study Arms (2)

working group

EXPERIMENTAL

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.

Combination Product: conservative treatment

control group

ACTIVE COMPARATOR

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.

Combination Product: conservative treatment

Interventions

conservative treatment COMBINATION_PRODUCT

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.

control group; working group

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: 25 years and older
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University

Adana, çukurova, 01250, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 24497443 BACKGROUND

• 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.

  PMID: 28447207 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Selen OZGOZEN, Dr

  dr

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The evaluator and the researcher working on the antioxidant panel will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: As a randomized controlled single blind

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 26, 2024
• Study Start: December 27, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)