Non-surgical treatment of pain associated with posterior tibial tendon dysfunction: study protocol for a randomised clinical trial

Blasimann, Angela; Eichelberger, Patric; Brülhart, Yvonne; El-Masri, Isam; Flückiger, Gerhard; Frauchiger, Lars; Huber, Martin; Weber, Martin; Krause, Fabian G.; Baur, Heiner

doi:10.1186/s13047-015-0095-4

Journal of Foot and Ankle Research

Table 1 Outcome measures

From: Non-surgical treatment of pain associated with posterior tibial tendon dysfunction: study protocol for a randomised clinical trial

Primary outcome measure	Unit
• Foot Function Index (FFI) – total score	sum score [0–230]
Secondary outcome measures	Unit
• Foot Function Index (FFI) – subcategory pain	sum score [0–90]
• Foot Function Index (FFI) – subcategory disability	sum score [0–90]
• Foot Function Index (FFI) – subcategory activity limitation	sum score [0–50]
Tertiary outcome measures	Unit
Additional assessment of functional impairment and current pain perception
• Pain Disability Index	Sum score [0–70]
• Visual Analog Scale (VAS) assessing pain (pre-post biomechanical testing)	Score [0–10]
Tertiary outcome measures from biomechanical data	Unit
Kinematic data from 3D movement analysis
Distance
• Dynamic navicular drop	Millimeter [mm]
Kinematic data from 3D movement analysis
Angular data: angle at initial contact, maximal manifestation during stance, range
• Foot Progression Angle	Angular degree [°]
• Forefoot to rearfoot dorsiflexion	Angular degree [°]
• Forefoot to rearfoot adduction	Angular degree [°]
• Forefoot to rearfoot supination	Angular degree [°]
• Ankle dorsiflexion	Angular degree [°]
• Ankle adduction	Angular degree [°]
• Ankle eversion	Angular degree [°]
(hindfoot with respect to tibia)	Angular degree [°]
• Ankle dorsiflexion	Angular degree [°]
• Ankle adduction	Angular degree [°]
• Ankle eversion	Angular degree [°]
(hindfoot with respect to lab)	Angular degree [°]
• Knee flexion	Angular degree [°]
• Knee adduction	Angular degree [°]
• Knee internal rotation	Angular degree [°]
• Hip flexion	Angular degree [°]
• Hip adduction	Angular degree [°]
• Hip internal rotation	Angular degree [°]
Neuromuscular activity
EMG of M. tibialis anterior, M. peroneus longus, M. gastrocnemius lateralis/medialis, M. soleus
• Onset of activation	% of stride
• Time of maximum activation	% of stride
• Total time of activation	% of stride
• Normalized amplitude in preactivation	arbitrary unit [uV/uV]
• Normalized amplitude in weight acceptance	arbitrary unit [uV/uV]
• Normalized amplitude in mid-stance	arbitrary unit [uV/uV]
• Normalized amplitude in push-off	arbitrary unit [uV/uV]

Primary, secondary and tertiary outcome measures of this RCT

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ISSN: 1757-1146

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