Combined Static and Dynamic Orthotic Treatment of the PIP Joint (StaDinOrt)

University of Malaga

Status and phase: Completed; Phase 4

Conditions: Health Behaviour

Treatments: Procedure: conventional treatment Physical Therapy; Procedure: dynamic extension contracture orthotic

Study type: Interventional

Funder types: Other

Identifiers

NCT01914991

FCCSS-UMA-02-13

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

62 participants in 2 patient groups

Control group

Active Comparator group

Description:

Conventional treatment: The treatment consisted of 10 minutes of local thermotherapy (paraffin), active exercises at the PIPJ and DIPJ (Distal interphalangeal joint), 3 sets of 15 repetitions of each exercise extending and flexing of the PIPJ with metacarpophalangeal joint from 0° to 90° respectively. Distal interphalangeal joint exercises were conducted with identical repetitions. The metacarpophalangeal joint and PIPJ exercises took place at 0 ° and involved stretching (5 sets of 3 reps, holding for 10 seconds) and Therapeutic U.S (0.8 w/cm2 / 7 minutes).

Treatment:

Procedure: conventional treatment Physical Therapy

Experimental group

Experimental group

Description:

dynamic extension contracture orthotic. A mobilizing force of 250 - 300 gm/cm2 was set in each one. Patients were instructed to wear it for at least 6 hours per day and then removed it for ADL (Activity Daily Living). A static orthosis was constructed using orfitcast material to the maximum, pain-free length allowed by the tissues at night. Static and dynamic orthoses were checked once a week and adjusted as necessary.

Treatment:

Procedure: dynamic extension contracture orthotic