Bracing and Strengthening for Posterior Tibial Tendon Dysfunction

NCT00756457 | Completed Phase 2 Results

• 1 other identifier: R15AR054507
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Posterior tibial tendon dysfunction (PTTD) is a problem with the tendon connecting one of the lower leg muscles to the foot bone. PTTD can cause pain, swelling, and a flattened foot and may require surgery if left untreated. Normal treatment for PTTD includes physical therapy exercise. In treating similar conditions in the lower leg, exercises that are active, like strengthening, seem to have better results than exercises that are passive, like stretching. This study will determine whether adding strengthening exercises to a normal PTTD treatment that includes wearing a brace and stretching is more beneficial than just wearing a brace and stretching.

Conditions

Posterior Tibial Tendon Dysfunction

Keywords

PTTD; Tendinopathy; Tendon Injuries; Muscular Diseases; Foot Diseases

Outcome Measures

Primary Outcomes (2)

• Foot Function Index(FFI)

  The Foot Function Index (FFI) is a validated disease specific questionnaire that has been used to document outcomes in uncontrolled studies of PTTD. The domains of the 23 item FFI questionnaire include pain, disability, and activity limitations. The scale was originally validated in subjects with foot problems related to rheumatoid arthritis patients, and has subsequently been used to measure outcomes for a variety of foot and ankle problems including plantar fasciitis, diabetes, and PTTD. In clinical trials, the FFI has been used to detect change attributable to orthotics, plantar fasciitis, and brace use in PTTD. The three domains of the FFI include pain (FFI-Pain) range 0 to 90, disability (FFI-Disability) range 0- 90, and activity limitations (FFI-Activity Limitations) range 0 to 50. Each category asks patients to rate items relative to pain with higher scores indicating greater pain. The average of the three scales is the FFI-Total.

  Measured at Weeks 1, 6, and 12

• Short Musculoskeletal Functional Assessment

  The Short Musculoskeletal Function Assessment Questionnaire (SMFA) is a 46 item self-report questionnaire consisting of the Dysfunction Index, which has thirty-four items, and the Bother index which has 12 items. The Dysfunction index is used for assessment of patient perceptions of functional performance while the Bother index is used to assess patients' perceptions of the degree patients are bothered in broad areas such as recreation and leisure. The responsiveness to change of the SMFA is 10 points out a range of 100 for each scale (Dysfunction, Mobility, and Bother indexes). The SMFA is also particularly suitable for the current investigation due to the presence of a sub-category of questions from the Dysfunction Index that pertains specifically to mobility (i.e. Mobility Index). Lower scores (lowest = 0) indicate better function, mobility, and that patients are less bothered while higher scores (highest = 100) indicate worse function, mobility and that patients are bothered.

  Measured at Weeks 1, 6, and 12

Secondary Outcomes (2)

• Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)

  Measured at Weeks 1,6 and 12

• Foot Strength

  Measured at Weeks 1, 6, and 12

Study Arms (2)

Active Treatment Group

ACTIVE COMPARATOR

Participants in Group A will undergo bracing and perform stretching exercises.

Device: Bracing; Other: Stretching exercises

Passive Treatment Group

EXPERIMENTAL

Participants in Group B will undergo bracing and perform stretching and strengthening exercises.

Device: Bracing; Other: Strengthening exercises; Other: Stretching exercises

Interventions

Bracing DEVICE

Participants will wear a brace that includes ankle stirrup support and medial longitudinal arch support. The brace will be worn during weight-bearing tasks throughout the 12-week study.

Also known as: Air Lift Brace

Active Treatment Group; Passive Treatment Group

Strengthening exercises OTHER

Participants performed strengthening exercises progressively longer each time for up to 3 sets of 30 repetitions twice daily by the third visit. Exercises included bilateral heel raises, foot adduction/rear foot inversion with thera-tubing, and unilateral heel raises. Participants increased resistance by using thera-bands with higher levels of resistance over the 12 week period. The amount of resistance was progressed according to patient tolerance at each visit. Strengthening exercises were preceded by the control stretching exercises which constituted a "warm up."

Passive Treatment Group

Stretching exercises OTHER

Subjects were provided with written descriptions and pictures demonstrating 2 range-of-motion exercises which included a wall calf stretch, and a supine ankle active range-of-motion exercise. Subjects were instructed to perform 3 sets of the stretching exercises, 2 times a day, similar to the intervention group. Each stretching exercise was performed twice and held for 30 seconds.

Active Treatment Group; Passive Treatment Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Stage II PTTD disorder
• Flexible flat foot deformity
• Palpable tenderness of posterior tibial tendon
• Swelling of the posterior tibial tendon sheath
• Pain during single limb heel rise
• Abnormal rear foot valgus
• Abnormal fore foot abduction as compared to contralateral side

You may not qualify if:

• Unable to walk for more than 15 meters
• Comorbidity within the foot
• Loss of protective sensation of the foot, as indicated by Semmes-Weinstein monofilament test of 5.07
• Inflammatory arthropathies
• Score greater than 23 on Mini Mental Status exam
• Arch index of less than 0.255
• Inability to assume a subtalar neutral posture
• PTTD in both feet

Sponsors & Collaborators

• Ithaca College: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Ithaca College - Rochester Center

Rochester, New York, 14620, United States

Location

Related Publications (1)

• Houck J, Neville C, Tome J, Flemister A. Randomized Controlled Trial Comparing Orthosis Augmented by Either Stretching or Stretching and Strengthening for Stage II Tibialis Posterior Tendon Dysfunction. Foot Ankle Int. 2015 Sep;36(9):1006-16. doi: 10.1177/1071100715579906. Epub 2015 Apr 9.

  PMID: 25857939 DERIVED

MeSH Terms

Conditions

Posterior Tibial Tendon Dysfunction; Tendinopathy; Tendon Injuries; Muscular Diseases; Foot Diseases

Interventions

Braces; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Wounds and Injuries; Neuromuscular Diseases; Nervous System Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Jeff Houck, PhD
• Organization: Ithaca College

jhouck@ithaca.edu

585-340-9619

Study Officials

• Jeff R. Houck, PhD, PT

  Ithaca College - Rochester Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 22, 2008
• Study Start: July 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 2, 2014
• Results First Posted: July 2, 2014

Record last verified: 2014-06

Locations

US (1)