Clinical trial NCT01914991: Combined Static and Dynamic Orthotic Treatment of the PIP Joint
Official title: Treatment of the PIP Joint Flexion Contracture: Combined Static and Dynamic Orthotic Intervention Compared With Traditional Combine Therapy. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Health Behaviour
Keywords: proximal interphalangeal joint
Orthoses
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study Design: Randomized controlled clinical study. Introduction: Physiotherapeutic intervention aiming to restore mobility using different techniques as stretching, hot packs, exercises, therapeutic ultrasound and orthotics. No scientific evidence has been found correlating improved joint mobility and the use of these techniques. Application techniques of orthoses to reshape the soft tissues have been well detailed, however, no scientific evidence supporting their effectiveness on proximal interphalangeal joint (PIPJ) lag extension resolution using them as a single treatment has been found.

Purpose of the Study: The purpose of the study was to test the effectiveness of static and dynamic orthosis in patients with a PIPJ flexion retraction using them as a single treatment compared with traditional combined therapies.

Method: 63 participants were included in the study. Patients who used splints were compared to a control group who received conventional treatment. Active and passive mobility were measured before the experiment and again three months after. All the patients were measured under the same conditions and treated by the same hand therapist. The relationship between contracture resolution and function was measured using the DASH Spanish Version.


Eligibility criteria: INCLUSION CRITERIO:

* 18 years old
* had given their consent
* having suffered trauma to the hand or finger which has resulted in joint damage with a consequent loss of full extension of the PIPJ
* duration of the injury being between four and 30 weeks.

EXCLUSION CRITERIA:

* Patients who had no proper joint alignment,
* Patients those with a presence of nerve or tendon associated dupuytren,
* campodactilea
* tubular bone fractures
* acute inflammatory signs
* joint instability
* avascular necrosis
* infection of the affected finger were not included in the study.

Primary outcomes:
measure: Active Range of motion AROM (degrees)
timeFrame: baseline; post-treatment (3 moths)
Secondary outcomes:
measure: Disability of the arm shoulder AND HAND (DASH QUESTIONNAIRE)
timeFrame: baseline; post-treatment (3 moths); 24 weeks follow up
measure: changes from postreatment Active range of Motion (AROM) degrees
timeFrame: 24 weeks follow up
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Centro Tecan
Study officials:
affiliation: University of Malaga
name: Antonio I Cuesta-Vargas, PhD
role: STUDY_DIRECTOR
References:
citation: Cantero-Tellez R, Cuesta-Vargas AI, Cuadros-Romero M. Treatment of proximal interphalangeal joint flexion contracture: combined static and dynamic orthotic intervention compared with other therapy intervention: a randomized controlled trial. J Hand Surg Am. 2015 May;40(5):951-5. doi: 10.1016/j.jhsa.2015.01.005. Epub 2015 Mar 11.