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Completed

NCT Number: NCT01914991

Combined Static and Dynamic Orthotic Treatment of the PIP Joint

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.

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Key information

Conditions

Health Behaviour

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro Tecan

Málaga, Malaga, 29009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: ORTHOTIC

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).

Other names: PHYSICAL THERAPY

Primary outcomes

  1. Active Range of motion AROM (degrees)

    Time frame: baseline; post-treatment (3 moths)

    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.

Secondary outcomes

  1. Disability of the arm shoulder AND HAND (DASH QUESTIONNAIRE)

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

    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.

  2. changes from postreatment Active range of Motion (AROM) degrees

    Time frame: 24 weeks follow up

    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.

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study title

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

Acronym: StaDinOrt

Important dates

Study start
2011
Primary completion
2011
Study completion
2013
First posted
Aug 2, 2013
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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