Scleroderma
Conditions
Brief summary
Hands are commonly affected in Systemic Sclerosis (SS). The objective of this research is to apply a home based hand care guide in patients with SS and to evaluate its response regarding hand pain, function, strength and mobility.
Detailed description
Introduction: Hands are commonly affected in Systemic sclerosis (SS). Skin thickening, Raynaud phenomenon, digital ulcers and cutaneous calcinosis may result in pain, disability and claw deformity. Strategies to improve hand function are recommended since its diagnosis and throughout the treatment. Unfortunately hand care assistance is not often available. The objective of this study was to developed a brief guide about hand care and home-based exercises to be applied in our outpatient clinic. Methods: A brief program , with instructions about the disease and home-based exercises will be applied in a group patients with Systemic Sclerosis (SS) during the period of 12 weeks. Hand function (Cochin Hand and Functional Scale), disability (HAQ-Scleroderma), quality of life (SF-36 hand pain (visual analogue scale), grip and pinch strength, hand mobility (delta finger) will be assessed in the first appointment and after twelve weeks.
Interventions
OTHERHandbook
The handbook named Hands on - a hand care guide in Systemic Sclerosis contains instructions about the Systemic Sclerosis and hand exercises.
Sponsors
University of Campinas, Brazil
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Systemic Scleroderma according to the American College of Rheumatology (Criteria Committee, Arthritis Rheum. 2013). * Involvement of hands with skin thickening. * Interest in participating in the investigation * Ability to read and to answer the the proposed questionnaires
Exclusion criteria
* Upper limb commitment due other reasons other than Systemic Sclerosis. * Presence of digital ulcers, hand deformities or conditins that impede the realization of the proposed exercises * Clinical manifestations that impede the performance of the proposed exercises
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cochin Hand Functional Scale | 08 weeks | The purpose of this self-report scale is to measure functional ability in the hand. The questions ask how much difficulty the person has performing 18 tasks without the help of any assistive device. Kitchen tasks include holding a bowl and a plate full of food, pouring liquid, cutting meat, and peeling fruit. The dressing items include buttoning and opening/closing a zipper. The hygiene items include squeezing a tube of toothpaste and holding a toothbrush. Office items include 2 writing tasks, while other items include turning a doorknob, cutting with scissors, and turning a key in a lock. Score range is from 0-90. A higher score indicates greater disability or more difficulty, whereas a lower score indicates less disability or difficulty. |
| Visual Analogue Pain Scale | 8 weeks | Hand pain (pain-VAS) was assessed using a 10 cm horizontal pain scale. Pain severity was rated from 0-10, where 0 = no pain and 10 = very severe pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delta Finger-to-palm | 8 weeks | The standard finger-to-palm (FTP) measurement is obtained using a ruler to measure the distance (in centimeters)between the tip of the pulp on the 3rd finger and the distal palmar crease while the patient attempts to make a full fist (maximal finger flexion at all 3 finger joints: MCP, PIP, and DIP). The delta FTP is finger extension, the distance between the 3rd fingertip and the distal palmar crease while the patient attempts full finger extension, minus the FTP. |
| Scleroderma Health Assessment Questionnaire | 8 weeks | The Health Assessment Questionnaire, is a self-administered 20-questionnaire that assesses functional ability in eight domains. Questions in each domain are scored in a four-point scale, from 0 (without difficulty) to 3 (unable to do). The maximum score from each domain is added together and divided by the number of categories completed (score ranging from 0 -better to 3 - worse). The Scleroderma Health Assessment Questionnaire (SHAQ) consists of the 20 items from the HAQ and has five additional questions that assess symptoms caused by Systemic Sclerosis (Raynaud Phemonomenon, digital tip ulcers, gastrointestinal and lung symptoms, as well as overall disease symptoms) using visual analogue scales (VAS). Scores on the VAS range from 0 (does not interfere with activities) to 3 (very severe limitations with activities). The overall score is the sum of each of the five VAS sub scores and the scores for the eight HAQ domains divided by 13. The SHAQ index ranges from 0 to 3. |
Countries
Brazil
Participant flow
Recruitment details
Patients with SSc were invited to take part in this study during their routine appointments at University of Campinas Rheumatology Outpatient Clinic.
Pre-assignment details
Patients were excluded if enrolled in other rehabilitation program in the previous three months, in the presence of hand disability due other pathologies rather than Systemic Sclerosis, or if they could not perform the exercises proposed as intevention due to medical conditions or advanced hand deformities.
Participants by arm
| Arm | Count |
|---|---|
| Handbook Group Patients with systemic scleroderma and hands commitment. | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | Handbook Group |
|---|---|
| Age, Continuous | 48.09 years STANDARD_DEVIATION 11.67 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment Brazil | 22 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Cochin Hand Functional Scale
The purpose of this self-report scale is to measure functional ability in the hand. The questions ask how much difficulty the person has performing 18 tasks without the help of any assistive device. Kitchen tasks include holding a bowl and a plate full of food, pouring liquid, cutting meat, and peeling fruit. The dressing items include buttoning and opening/closing a zipper. The hygiene items include squeezing a tube of toothpaste and holding a toothbrush. Office items include 2 writing tasks, while other items include turning a doorknob, cutting with scissors, and turning a key in a lock. Score range is from 0-90. A higher score indicates greater disability or more difficulty, whereas a lower score indicates less disability or difficulty.
Time frame: 08 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Handbook Group | Cochin Hand Functional Scale | 19.24 units on a scale | Standard Deviation 15.78 |
Primary
Visual Analogue Pain Scale
Hand pain (pain-VAS) was assessed using a 10 cm horizontal pain scale. Pain severity was rated from 0-10, where 0 = no pain and 10 = very severe pain
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Handbook Group | Visual Analogue Pain Scale | 3.97 units on a scale | Standard Deviation 4.5 |
Secondary
Delta Finger-to-palm
The standard finger-to-palm (FTP) measurement is obtained using a ruler to measure the distance (in centimeters)between the tip of the pulp on the 3rd finger and the distal palmar crease while the patient attempts to make a full fist (maximal finger flexion at all 3 finger joints: MCP, PIP, and DIP). The delta FTP is finger extension, the distance between the 3rd fingertip and the distal palmar crease while the patient attempts full finger extension, minus the FTP.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Handbook Group | Delta Finger-to-palm | 92.86 Centimeters | Standard Deviation 34.7 |
Secondary
Scleroderma Health Assessment Questionnaire
The Health Assessment Questionnaire, is a self-administered 20-questionnaire that assesses functional ability in eight domains. Questions in each domain are scored in a four-point scale, from 0 (without difficulty) to 3 (unable to do). The maximum score from each domain is added together and divided by the number of categories completed (score ranging from 0 -better to 3 - worse). The Scleroderma Health Assessment Questionnaire (SHAQ) consists of the 20 items from the HAQ and has five additional questions that assess symptoms caused by Systemic Sclerosis (Raynaud Phemonomenon, digital tip ulcers, gastrointestinal and lung symptoms, as well as overall disease symptoms) using visual analogue scales (VAS). Scores on the VAS range from 0 (does not interfere with activities) to 3 (very severe limitations with activities). The overall score is the sum of each of the five VAS sub scores and the scores for the eight HAQ domains divided by 13. The SHAQ index ranges from 0 to 3.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Handbook Group | Scleroderma Health Assessment Questionnaire | 0.95 units on a scale | Standard Deviation 0.53 |