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

Treatment of the PIP Joint Flexion Contracture: Combined Static and Dynamic Orthotic Intervention Compared With Traditional Combine Therapy. A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Health Behaviour
• Intervention / Treatment: Procedure: conventional treatment Physical Therapy; Procedure: dynamic extension contracture orthotic

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Malaga, Spain, 29009
    • Centro Tecan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 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).	Procedure: conventional treatment Physical Therapy; Traditional treatment was applied to one control group. 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).; Other Names: PHYSICAL THERAPY
Experimental: Experimental group; 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.	Procedure: dynamic extension contracture orthotic; A dynamic orthosis was constructed in the experimental group using the same style of 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.; Other Names: ORTHOTIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active Range of motion AROM (degrees)	AROM and function were measured in all patients at inclusion and at three months after the start of the study. which was measured using a short arm goniometer Stainless Baseline 180°. A lateral measurement following the standardized protocol recommended by the American Society of Hand Therapists was used.	baseline; post-treatment (3 moths)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability of the arm shoulder AND HAND (DASH QUESTIONNAIRE)	The Spanish standard version of DASH instrument (Rosales et al. 2002) (www.dash.iwh.on.ca) for measuring upper extremity disability was used as a secondary outcome measurement. The questionnaire was given to the participants the day before starting the treatment and again after three months.	baseline; post-treatment (3 moths); 24 weeks follow up
changes from postreatment Active range of Motion (AROM) degrees	AROM and function were measured in all patients at inclusion and at three months after the start of the study. which was measured using a short arm goniometer Stainless Baseline 180°. A lateral measurement following the standardized protocol recommended by the American Society of Hand Therapists was used.	24 weeks follow up

Collaborators and Investigators

• Sponsor: University of Malaga

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: July 24, 2013
• First Submitted That Met QC Criteria: August 1, 2013
• First Posted (Estimate): August 2, 2013

Study Record Updates

• Last Update Posted (Estimate): May 6, 2014
• Last Update Submitted That Met QC Criteria: May 5, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: proximal interphalangeal joint; Orthoses
• Other Study ID Numbers: FCCSS-UMA-02-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No