SclerodermaNCT06474910
Connective Tissue Massage in Scleroderma
A study testing Connective tissue massage and Exercise in people with Scleroderma, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
The only study in the literature that examined connective tissue massage in patients with scleroderma is by Bongi et al. In this study, connective tissue massage and Mc Mennell joint manipulation technique were applied to the experimental group in addition to the home exercise program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Scleroderma
- What is being tested?
- Connective tissue massage and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jun 2024to 20 Sep 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-65
- Stable on medical treatment
- Be able to adapt to exercise
Who cannot join
- Diagnosed with juvenile onset scleroderma
- Accompanied by another rheumatic disease
- Active digital ulcer
- Chronic disease or trauma history that will affect hand functions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Songul Baglan Yentur
Elâzığ, 23100
Songul Baglan Yentur, 04242370000, songulbaglan23@hotmail.com
Songul Baglan Yentur, songulbaglan23@hotmail.com
About this study
Official title: Connective Tissue Massage in Patients With Scleroderma
The only study in the literature that examined connective tissue massage in patients with scleroderma is by Bongi et al. In this study, connective tissue massage and Mc Mennell joint manipulation technique were applied to the experimental group in addition to the home exercise program. The control group was offered only a home exercise program. The results of the study showed that the group in which connective tissue massage and Mc Mennell joint manipulation technique were applied were effective on hand functions, quality of life and mobility. The aim of our study was to examine the effects of connective tissue massage applied in addition to the exercise program.The study will include 30 patients diagnosed with scleroderma according to American College of Rheumatology/European League Against Rheumatism criteria and followed up in Fırat University Rheumatology Department. Patients will be divided into two groups; 15 patients in the first group will be applied connective tissue massage to the hand and forearm area in addition to the exercise program for hand rehabilitation. In the second group, 15 patients will only receive an exercise program.
Read the detailed description
Although there are various physiotherapy interventions in scleroderma rehabilitation, there is no definitive guideline. Passive and active stretching has been shown to help maintain range of motion (ROM) and optimal length of structures. Home exercises form part of rehabilitation in most studies. The only study in the literature that examined connective tissue massage in patients with scleroderma is by Bongi et al. In this study, connective tissue massage and Mc Mennell joint manipulation technique were applied to the experimental group in addition to the home exercise program. The control group was offered only a home exercise program. The results of the study showed that the group in which connective tissue massage and Mc Mennell joint manipulation technique were applied were effective on hand functions, quality of life and mobility. The aim of our study was to examine the effects of connective tissue massage applied in addition to the exercise program.The study will include 30 patients diagnosed with scleroderma according to American College of Rheumatology/European League Against Rheumatism criteria and followed up in Fırat University Rheumatology Department. Patients will be divided into two groups; 15 patients in the first group will be applied connective tissue massage to the hand and forearm area in addition to the exercise program for hand rehabilitation. In the second group, 15 patients will only receive an exercise program. Range of motion, skin thickness and hand mobility test will be evaluated.
- Conditions
- Scleroderma
- Being tested
- Connective tissue massage, Exercise
- Keywords
- Scleroderma, Connective tissue massage, mobility
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue massageOther
In addition to the exercise program for hand rehabilitation, 15 patients in this group will receive connective tissue massage of the hand and forearm area. The exercise program will include stretching exercises for the hand, strengthening exercises, normal joint movement exercises, functional exercises and tendon sliding exercises.
ExerciseOther
Only exercise program will be applied to 15 patients in this group. The exercise program will include stretching exercises for the hand, strengthening exercises, normal joint movement exercises, functional exercises and tendon sliding exercises.
| Study group | Role | What they receive |
|---|---|---|
| Connective tissue massage group | Experimental | In addition to the exercise program for hand rehabilitation, 15 patients in this group will receive connective tissue massage of the hand and forearm area. The exercise program will include stretching exercises for the hand, strengthening exercises, normal joint movement exercises, functional exercises and tendon sliding exercises. Receives: Other: Connective tissue massage |
| Exercise group | Experimental | Only exercise program will be applied to 15 patients in this group. The exercise program will include stretching exercises for the hand, strengthening exercises, normal joint movement exercises, functional exercises and tendon sliding exercises. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility assessment
The hand function test developed for SSc patients will be used to assess specific functions of the patients. The ability to use the hand in daily tasks and limitation of movement will be evaluated. Finger movements, grasping, releasing, pronation, supination movements are scored between 0-3.
Measured: 2 minutes
Secondary outcomes (2)
Skin thickness assessment
The modified Rodnan skin score (mRSS) will be used to assess skin thickness. Normal skin thickness will be scored as zero, mild skin thickening as one, difficulty in making skin folds and wrinkle-free skin thickness as two, inability to hold the skin between two fingers and severe skin thickness as three.
Measured: 1 minute
Range of motion assessment
The ROM of the fingers will be measured with a finger goniometer. Distal interphalangeal (DIP), proximal interphalangeal (PIP) and metacarpophalangeal (MCP) joint flexion ranges of motion will be measured with the forearm and wrist in neutral position and fingers in maximum flexion (fist position).
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start21 Jun 2024 (estimated)
- Primary completion20 Aug 2024 (estimated)
- Study completion20 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül Bağlan Yentür, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474910
- Sponsor's protocol ID
- 2024/07-34
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connective Tissue Massage in Patients With Scleroderma
- ClinicalTrials.gov ID
- NCT06474910
- Acronym / sponsor ID
- 2024/07-34
- Conditions
- Scleroderma
- Keywords
- Scleroderma, Connective tissue massage, mobility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 21 Jun 2024 (estimated)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 26 Jun 2024 (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.
The only study in the literature that examined connective tissue massage in patients with scleroderma is by Bongi et al. In this study, connective tissue massage and Mc Mennell joint manipulation technique were applied to the experimental group in addition to the home exercise program. The control group was offered only a home exercise program. The results of the study showed that the group in which connective tissue massage and Mc Mennell joint manipulation technique were applied were effective on hand functions, quality of life and mobility. The aim of our study was to examine the effects of connective tissue massage applied in addition to the exercise program.The study will include 30 patients diagnosed with scleroderma according to American College of Rheumatology/European League Against Rheumatism criteria and followed up in Fırat University Rheumatology Department. Patients will be divided into two groups; 15 patients in the first group will be applied connective tissue massage to the hand and forearm area in addition to the exercise program for hand rehabilitation. In the second group, 15 patients will only receive an exercise program.
Detailed description
Although there are various physiotherapy interventions in scleroderma rehabilitation, there is no definitive guideline. Passive and active stretching has been shown to help maintain range of motion (ROM) and optimal length of structures. Home exercises form part of rehabilitation in most studies. The only study in the literature that examined connective tissue massage in patients with scleroderma is by Bongi et al. In this study, connective tissue massage and Mc Mennell joint manipulation technique were applied to the experimental group in addition to the home exercise program. The control group was offered only a home exercise program. The results of the study showed that the group in which connective tissue massage and Mc Mennell joint manipulation technique were applied were effective on hand functions, quality of life and mobility. The aim of our study was to examine the effects of connective tissue massage applied in addition to the exercise program.The study will include 30 patients diagnosed with scleroderma according to American College of Rheumatology/European League Against Rheumatism criteria and followed up in Fırat University Rheumatology Department. Patients will be divided into two groups; 15 patients in the first group will be applied connective tissue massage to the hand and forearm area in addition to the exercise program for hand rehabilitation. In the second group, 15 patients will only receive an exercise program. Range of motion, skin thickness and hand mobility test will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective tissue massage group | Experimental | Other: Connective tissue massageIn addition to the exercise program for hand rehabilitation, 15 patients in this group will receive connective tissue massage of the hand and forearm area. The exercise program will include stretching exercises for the hand, strengthening exercises, normal joint movement exercises, functional exercises and tendon sliding exercises. |
| Exercise group | Experimental | Other: ExerciseOnly exercise program will be applied to 15 patients in this group. The exercise program will include stretching exercises for the hand, strengthening exercises, normal joint movement exercises, functional exercises and tendon sliding exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18-65
- Stable on medical treatment
- Be able to adapt to exercise
Key exclusion criteria (4 listed)
- Diagnosed with juvenile onset scleroderma
- Accompanied by another rheumatic disease
- Active digital ulcer
- Chronic disease or trauma history that will affect hand functions
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 |
|---|---|---|
| Connective tissue massageIn addition to the exercise program for hand rehabilitation, 15 patients in this group will receive connective tissue massage of the hand and forearm area. The exercise program will include stretching exercises for the hand, strengthening exercises, normal joint movement exercises, functional exercises and tendon sliding exercises. | Other | Connective tissue massage group |
| ExerciseOnly exercise program will be applied to 15 patients in this group. The exercise program will include stretching exercises for the hand, strengthening exercises, normal joint movement exercises, functional exercises and tendon sliding exercises. | Other | Exercise group |
Primary outcome
Mobility assessment
Time frame: 2 minutes
The hand function test developed for SSc patients will be used to assess specific functions of the patients. The ability to use the hand in daily tasks and limitation of movement will be evaluated. Finger movements, grasping, releasing, pronation, supination movements are scored between 0-3.
2 secondary outcomes
Skin thickness assessment
Time frame: 1 minute
Range of motion assessment
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Scleroderma
RecruitingPhase 3
Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 1
A Study of ATG-201 in Adult Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Systemic Sclerosis (SSc)
RecruitingPhase 1
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
SLE (Systemic Lupus), Lupus Erythematosus, Systemic
Active, not recruiting
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Scleroderma, Systemic, Morphea
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue massage and Exercise in people with Scleroderma, run by Firat 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 4 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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Songul Baglan Yentur (+90 424 2370000, songulbaglan23@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility assessment (time frame: 2 minutes). 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 26 Jun 2024.