Combined Static and Dynamic Orthotic Treatment of the PIP Joint

NCT01914991 | Completed Phase 4 DMC

• 1 other identifier: FCCSS-UMA-02-13
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behaviour

Keywords

proximal interphalangeal joint; Orthoses

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Disability of the arm shoulder AND HAND (DASH QUESTIONNAIRE)

  baseline; post-treatment (3 moths); 24 weeks follow up

• changes from postreatment Active range of Motion (AROM) degrees

  24 weeks follow up

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Experimental group

EXPERIMENTAL

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

Interventions

dynamic extension contracture orthotic PROCEDURE

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.

Also known as: ORTHOTIC

Experimental group

conventional treatment Physical Therapy PROCEDURE

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).

Also known as: PHYSICAL THERAPY

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Centro Tecan

Málaga, Malaga, 29009, Spain

Location

Related Publications (1)

• 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.

  PMID: 25771480 DERIVED

MeSH Terms

Interventions

Orthotic Devices; Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Therapeutics; Rehabilitation

Study Officials

• Antonio I Cuesta-Vargas, PhD

  University of Malaga

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: August 2, 2013
• Study Start: June 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: January 1, 2013
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

ES (1)