Serial Night Time Position Splint on Systemic Sclerosis

Federal University of São Paulo

Status and phase: Unknown; Phase 3

Conditions: Diffuse Systemic Sclerosis

Treatments: Drug: Drug treatment; Device: Serial night time position splint

Study type: Interventional

Funder types: Other

Identifiers

NCT01586663

CEP 1070/09

Details and patient eligibility

About

This is a randomized controlled trial with blinded evaluator and follow-up of one year. Seventy six patients with diffuse systemic sclerosis, will be randomized into two groups.The patients can not change their medication during the study. Patients will be evaluated at baseline and at 3, 6, 9 and 12 months. The experimental group will use a serial night time position splint who will be adjusted monthly, while the control group will remain the drug treatment. The outcomes assessed will be: pain, hand range of motion, quality of life, functional capacity, upper limb function and dexterity. Our hypothesis is that the serial night time position splint will improve the hand range of motion in diffuse systemic sclerosis patients.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diffuse Systemic scleroses diagnosed following the ACR criteria
• Older than 18 years old
• Sclerodactyly

Exclusion criteria

• Neurological, psychiatric diseases and other rheumatic disease (including overlapping)
• Previous use of splints or allergy to splint material
• Surgery schedule to the next 12 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

76 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Splint group

Treatment:

Device: Serial night time position splint

Control Group

Active Comparator group

Description:

Drug treatment

Treatment:

Drug: Drug treatment