Connective Tissue Massage in Scleroderma

June 25, 2024 updated by: Songül Bağlan Yentür, Firat University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Connective tissue massage group
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
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.
Experimental: Exercise 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.
Other: Exercise
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin thickness assessment
Time Frame: 1 minute
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.
1 minute
Range of motion assessment
Time Frame: 2 minutes
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).
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 21, 2024

Primary Completion (Estimated)

August 20, 2024

Study Completion (Estimated)

September 20, 2024

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/07-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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