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Efficacy of Manual Therapy and Therapeutic Exercises in the hands of patients with Systemic Sclerosis - a randomized controlled clinical trial

Efficacy of Articular Mobilization and Kinesiotherapy in the functionality of the hands of patients with Systemic Sclerosis - controlled and randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4w8xn2
Enrollment
Unknown
Registered
2019-06-17
Start date
2019-01-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

Interventions

Physiotherapy group: 12 participants Were be realized: Joint mobilization (Maitland Concept) for 40 minutes in both hands, wrist joints, metacarpals and phalanges. Kinesiotherapy for 20 minutes (free
Other
G11.427.410.698.277
E02.190.599

Sponsors

Universidade Federal de Pernambuco
Lead Sponsor
Coordenação de Aperfeiçoamento de Pessoal de Nivel Superior - CAPES
Collaborator

Eligibility

Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Diagnosis of systemic sclerosis by rheumatologist; 18 years of age or over; presence of impairment of the functionality of the hand determined by score in Cochin scale greater or equal 10.

Exclusion criteria

Exclusion criteria: Superposition with other autoimmune or inflammatory rheumatologic diseases; presence of scleroderma-like diseases (eosinophilic fasciitis, nephrogenic systemic fibrosis, scleromyxedema); presence of acute arthritis or myositis in activity; presence of ulcers in active hands; presence of amputation in upper limbs; physical therapy in the last three months; difficulty in moving or unable to attend the scheduled treatment sessions.

Design outcomes

Primary

MeasureTime frame
Primary outcome 1: Functionality of hands - Measured by Cochin Hand Functional Scale (COCHIN) at the first evaluation, after 6 weeks and after 12 weeks in both groups. A variation of 11.8 points is required to be clinically significant.

Secondary

MeasureTime frame
Secondary outcome 3 Range of Hand Movement: Measured by Delta finger-to-palm (DFTP) and Modified Hand Mobility in Scleroderma (HAMIS). DFTP: measured with a ruler (cm) the flexion movement of the fingers, check if there was decrease in cm after 6 and 12 weeks. HAMIS: Each item is rated on a scale of 0 (no difficulty) to 3 (can not do), with a total score of up to 12 points for each hand.;Secondary outcome 4 Muscle strength: As measured by the dynamometer, the force is recorded in kilograms (kg), it is expected to increase the force through the KG after 12 weeks of intervention.;Secondary Outcome 5 Pain: Measured by Visual Analogue Scale (EVA). Used a ruler from 0 to 10 cm, 0 (without pain) and 10 (greater pain experience).;Secondary Outcome 6 Adverse events: Measured through a questionnaire prepared by the researchers. Qualitative measure.;Secondary Outcome 7 Perception of change: Measured by the evaluation of the scale of global perception of change (PGIC Portuguese version). Being classified with the numberings of 1 (without changes) to 7 (much better).;Secondary Outcome 1 Disability: Measured by the Scleroderma Health Assessment Questionnaire (SHAQ) ranging from 0 to 3 - without any difficulty (0), with some difficulty (1), with great difficulty (2) and unable to do (3). The score range from 0 to 3 represents the minimum limitation for 0 and maximum for 3.;Secondary Outcome 2 Quality of life: Measured by the Medical Outcome Study Short Form 12-Item (SF-12). Being 0 the worst result and 100 the best result related to health.

Countries

Brazil

Contacts

Public ContactAndréa ;Letticia Dantas;Roque

Universidade Federal de Pernambuco ;Universidade Federal de Pernambuco

andreatdantas@gmail.com;letticia_cristina@hotmail.com+5581991721582;+5581985421393

Outcome results

None listed

Source: REBEC (via WHO ICTRP)