Bracing and Strengthening for Posterior Tibial Tendon Dysfunction

This study has been completed.
Sponsor:
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00756457
First received: September 19, 2008
Last updated: May 5, 2009
Last verified: May 2009

September 19, 2008
May 5, 2009
July 2007
September 2008   (final data collection date for primary outcome measure)
Foot function index [ Time Frame: Measured at Weeks 1, 6, and 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00756457 on ClinicalTrials.gov Archive Site
Foot kinematics and posterior tibial muscle length (estimated from foot kinematics) [ Time Frame: Measured at baseline and Weeks 6 and 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bracing and Strengthening for Posterior Tibial Tendon Dysfunction
The Effect of Bracing and Strengthening Exercises on Posterior Tibial Tendon Dysfunction

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.

Posterior tibial tendon dysfunction (PTTD) involves inflammation, overstretching, or both of the posterial tibial tendon, which connects the tibialis posterior muscle to the bones in the foot. PTTD can cause pain in the inner ankle and development of a flat foot. Without treatment, correction of PTTD may require surgery. Standard interventions that may prevent the need for surgery include orthotic devices, bracing, and physical therapy, among other possibilities. Within physical therapy, foot exercises can be either active—as in the case of strengthening exercises—or passive—as in the case of stretching exercises. Evidence from clinical treatment of similar conditions suggests that active exercises are more effective than passive exercises in leading to recovery. This study will determine whether adding strengthening exercises to a normal intervention of bracing and stretching is more effective in improving a range of symptoms in stage II PTTD patients than using only bracing and stretching exercises.

Participants with Stage II PTTD will be recruited and placed in one of two groups for the duration of the 12-week study. The first group will undergo regular bracing and perform stretching exercises. The second group will undergo regular bracing and perform stretching and strengthening exercises. Braces, worn during weight-bearing tasks throughout the study, will include ankle stirrup support and medial longitudinal arch support. Strengthening exercises, which will be preceded by a warm-up of the posterior tibialis muscle, will include bilateral heel raises, foot adduction and rear foot inversion with thera-tubing, and unilateral heel raises. Frequency of exercise and number of repetitions will increase over the course of the study until participants are performing 3 sets of 30 repetitions 2 times per day. Assessments, which will occur at study entry, after 6 weeks, and after 12 weeks, will include foot range of motion, length of the posterior tibial muscle, and self-assessments of function.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Posterior Tibial Tendon Dysfunction
  • Device: Bracing
    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.
    Other Name: Air Lift Brace
  • Other: Strengthening exercises
    Participants will perform strengthening exercises progressively longer each time for up to 3 sets of 30 repetitions twice daily by the third visit. Exercises will include bilateral heel raises, foot adduction/rear foot inversion with thera-tubing, and unilateral heel raises. Strengthening exercises will be preceded by a warm-up of the posterior tibialis muscle.
  • Other: Stretching exercises
    Participants will perform stretching exercises.
  • Active Comparator: A
    Participants in Group A will undergo bracing and perform stretching exercises.
    Interventions:
    • Device: Bracing
    • Other: Stretching exercises
  • Experimental: B
    Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
    Interventions:
    • Device: Bracing
    • Other: Strengthening exercises
    • Other: Stretching exercises
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00756457
R15 AR054507
No
Dr. Jeff R. Houck, Associate Professor, Ithaca College-Rochester Center
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Not Provided
Principal Investigator: Jeff R. Houck, PhD, PT Ithaca College - Rochester Center
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP