Combined Static and Dynamic Orthotic Treatment of the PIP Joint

NCT ID: NCT01914991

Last Updated: 2014-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

conventional treatment Physical Therapy

Intervention Type: 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).

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.

Group Type: EXPERIMENTAL

dynamic extension contracture orthotic

Intervention Type: 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.

Interventions

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.

Intervention Type: 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).

Intervention Type: PROCEDURE

Other Intervention Names

ORTHOTIC; PHYSICAL THERAPY

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Dr. Antonio I Cuesta-Vargas

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio I Cuesta-Vargas, PhD

Role: STUDY_DIRECTOR

University of Malaga

Locations

Centro Tecan

Málaga, Malaga, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 25771480 (View on PubMed)

Other Identifiers

FCCSS-UMA-02-13

Identifier Type: -

Identifier Source: org_study_id