NCT06474910

Brief 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. 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

June 21, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 20, 2024

Last Update Submit

June 25, 2024

Conditions

Keywords

SclerodermaConnective tissue massagemobility

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 minutes

Secondary Outcomes (2)

  • Skin thickness assessment

    1 minute

  • Range of motion assessment

    2 minutes

Study Arms (2)

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.

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.

Other: Exercise

Interventions

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.

Connective tissue massage group

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.

Exercise group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 18-65
  • Stable on medical treatment
  • Be able to adapt to exercise

You may not qualify if:

  • Diagnosed with juvenile onset scleroderma
  • Accompanied by another rheumatic disease
  • Active digital ulcer
  • Chronic disease or trauma history that will affect hand functions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songul Baglan Yentur

Elâzığ, 23100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

Exercise

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Physiotherapy and Rehabilitation Department

Study Record Dates

First Submitted

June 20, 2024

First Posted

June 26, 2024

Study Start

June 21, 2024

Primary Completion

August 20, 2024

Study Completion

September 20, 2024

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations