Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid ArthritisNCT05529537
Manual Lymphatic Drainage for Rheumatoid Arthritis
A study testing manual lymphatic drainage and excersize in people with Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease characterized by inflammation of the synovial joints and tendon sheaths. As a result of synovitis, progressive damage occurs in cartilage, bone and joints. This damage leads to severe functional limitations and deterioration in quality of life. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis
- What is being tested?
- manual lymphatic drainage and excersize
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Aug 2022to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with RA according to ACR criteria
- Being between the ages of 18-65
- Volunteering to participate in the study
Who cannot join
- Presence of neuromuscular disease
- Having difficulty walking
- Cognitive impairment
- Having systemic disease such as diabetes mellitus and osteoarthritis
- History of upper extremity sIf you have Hand Deformity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Science University Hospital
Kütahya, 43100
About this study
Official title: The Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis Patients
Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease characterized by inflammation of the synovial joints and tendon sheaths. As a result of synovitis, progressive damage occurs in cartilage, bone and joints. This damage leads to severe functional limitations and deterioration in quality of life. Synovial tissues are the main site of involvement. Manual lymph drainage reduces the levels of inflammatory mediators associated with edema and pain in the acute phase. On the basis of this concept; Stimulating the lymph system and increasing circulation, removing biochemical residues, regulating sympathetic and parasympathetic system responses, and thus reducing edema and pain. The increase in cardiac parasympathetic activity measured after MLD also contributes to relaxation. In addition to the transport of lymphatic fluid, manual lymph drainage stimulates free nerve endings in the skin with the touches it contains. Gentle stimulation to the skin increases tactile input and closes the pain pathways. In addition, the superficial relaxation and warming provided by soft stimulation creates an effect on the autonomic nervous system and activates the parasympathetic system. The aim of this study is to evaluate the effect of manual lymphatic drainage on upper extremity functionality in individuals with rheumatoid arthritis.
- Conditions
- Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis
- Being tested
- manual lymphatic drainage, excersize
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual lymphatic drainageOther
In addition to conventional treatment for 4 weeks, manual lymph drainage will be applied to the patients.
excersizeOther
upper extremity normal joint range of motion exercise, strengthening exercise, tendon gliding exercises
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | Not described Receives: Other: excersize |
| MLD | Experimental | Not described Receives: Other: manual lymphatic drainage; Other: excersize |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rheumatoid Arthritis Quality of Life Scale (QOL-RA)
In the scale consisting of 30 questions; questions are scored as "yes-1" and "no-0". The scores obtained range from 0-30, and high scores indicate poor quality of life.
Measured: 10 minutes
pressure pain threshold
It is used for the assessment of sensitivity to pain and the determination of pressure perception. will be evaluated with a digital algometer device with a surface area of 1 cm2 and a sensitivity of 0.25 kg/cm2 (Jtech Medical Industries, ZEVEX Company, USA).
Measured: 5 minutes
hand grip strength
The Jamar hand dynamometer, which is recommended by the American Association of Hand Therapists (AETD) and has high validity and reliability in many studies and is therefore accepted as the gold standard, will be used.
Measured: 5 minutes
finger grip strength
Finger pinchmeter (Baseline) will be used to measure finger grip strength.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start17 Aug 2022
- Primary completion30 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Cihan, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529537
- Sponsor's protocol ID
- 2022/08-01
- Status last verified
- Dec 2022
- First submitted
- 1 Sep 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT05529537
- Acronym / sponsor ID
- 2022/08-01
- Conditions
- Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease characterized by inflammation of the synovial joints and tendon sheaths. As a result of synovitis, progressive damage occurs in cartilage, bone and joints. This damage leads to severe functional limitations and deterioration in quality of life. Synovial tissues are the main site of involvement. Manual lymph drainage reduces the levels of inflammatory mediators associated with edema and pain in the acute phase. On the basis of this concept; Stimulating the lymph system and increasing circulation, removing biochemical residues, regulating sympathetic and parasympathetic system responses, and thus reducing edema and pain. The increase in cardiac parasympathetic activity measured after MLD also contributes to relaxation. In addition to the transport of lymphatic fluid, manual lymph drainage stimulates free nerve endings in the skin with the touches it contains. Gentle stimulation to the skin increases tactile input and closes the pain pathways. In addition, the superficial relaxation and warming provided by soft stimulation creates an effect on the autonomic nervous system and activates the parasympathetic system. The aim of this study is to evaluate the effect of manual lymphatic drainage on upper extremity functionality in individuals with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: excersize |
| MLD | Experimental | Other: manual lymphatic drainage, Other: excersize |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with RA according to ACR criteria
- Being between the ages of 18-65
- Volunteering to participate in the study
Key exclusion criteria (5 listed)
- Presence of neuromuscular disease
- Having difficulty walking
- Cognitive impairment
- Having systemic disease such as diabetes mellitus and osteoarthritis
- History of upper extremity sIf you have Hand Deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manual lymphatic drainageIn addition to conventional treatment for 4 weeks, manual lymph drainage will be applied to the patients. | Other | MLD |
| excersizeupper extremity normal joint range of motion exercise, strengthening exercise, tendon gliding exercises | Other | MLD, control |
Primary outcome
Rheumatoid Arthritis Quality of Life Scale (QOL-RA)
Time frame: 10 minutes
In the scale consisting of 30 questions; questions are scored as "yes-1" and "no-0". The scores obtained range from 0-30, and high scores indicate poor quality of life.
pressure pain threshold
Time frame: 5 minutes
It is used for the assessment of sensitivity to pain and the determination of pressure perception. will be evaluated with a digital algometer device with a surface area of 1 cm2 and a sensitivity of 0.25 kg/cm2 (Jtech Medical Industries, ZEVEX Company, USA).
hand grip strength
Time frame: 5 minutes
The Jamar hand dynamometer, which is recommended by the American Association of Hand Therapists (AETD) and has high validity and reliability in many studies and is therefore accepted as the gold standard, will be used.
finger grip strength
Time frame: 5 minutes
Finger pinchmeter (Baseline) will be used to measure finger grip strength.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual lymphatic drainage and excersize in people with Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rheumatoid Arthritis Quality of Life Scale (QOL-RA) (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.