Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Heel Pain in Adolescents: A Pilot Study on the Effectiveness of Exercise Therapy and Activity Modification

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04816188
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Karin Silbernagel, University of Delaware

Tracking Information
First Submitted Date  ICMJE March 18, 2021
First Posted Date  ICMJE March 25, 2021
Last Update Posted Date April 27, 2021
Estimated Study Start Date  ICMJE April 2021
Estimated Primary Completion Date August 25, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
  • Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire [ Time Frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks ]
    The VISA-A was specifically designed to assess symptom severity in individuals with Achilles tendinopathy and has demonstrated validity, reliability and responsiveness. Scores range from 0-100, where a higher score indicates less pain and symptoms with activity. This outcome measure has been used in previous trials with adolescents.
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Scale [ Time Frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks ]
    The PROMIS Pain Interference Scale assesses symptom severity and pain with daily activity. Raw scores range from 8-40, where lower scores indicate less pain interference.
  • Tendon Structure [ Time Frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks ]
    Ultrasound images will be obtained using the LOGIQ e Ultrasound (GE Healthcare) system using a wide-band linear array probe (5.0-13.0 MHz). The subject will be prone lying with the hips and knees straight and the ankles hanging outside the treatment table. Three longitudinal images where the calcaneal insertion and as much of the tendon is visible will be saved. Three extended field of view images of the tendon between the insertion to the calcaneus and the start of the soleus muscle will be saved. Longitudinal and cross-sectional images will be taken at the area of tenderness to palpation on the injured side and at the same position on the contralateral side. These images will be used to evaluate tendon thickening, cross-sectional area, and the occurrence of hypoechoic areas.
  • Tendon Mechanical Properties [ Time Frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks ]
    Subjects will be examined using continuous shear wave elastography (cSWE). This is a non-invasive technique that uses a low-amplitude vibration to mechanically perturbate the tendon. The resultant shear wave is imaged using ultrasound. The area of maximum tendon pathology will be identified using palpation and B mode ultrasound imaging. The distance from calcaneal insertion to this area will be measured to allow for identification of a comparable location on the asymptomatic side as well as to ensure the same area is assessed at each follow-up. The ultrasound probe for cSWE will be placed at this location and the actuator will be placed just proximal to the ultrasound probe.
  • Muscle-Tendon Function [ Time Frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks ]
    Muscle-tendon function will be assessed by a functional test battery including a single-leg counter movement jump (CMJ), a single-leg drop CMJ, single-leg hopping, and the heel-rise endurance test. For jump tests, the jump height for three trials will be recorded using a light mat (MuscleLab®, Ergotest Innovations, Porsgrunn, Norway). The drop CMJ jump is performed on single leg by jumping from a 20cm high box, landing, and immediately jumping up for maximum height. Hopping is similar or jumping rope on one foot; two trials of 20 hops will be recorded using a light mat to calculate hop frequency, average height, and plyometric quotient (flight time / contact time). The heel-rise endurance test is a single-leg standing heel-rise test. The heel-rise test for endurance is performed on one leg at a time with the participant standing on a box with an incline of 10°. A metronome is used to maintain the frequency of 30 heel-rises per minute.
  • Compliance [ Time Frame: Average compliance rate for each group over first year of study recruitment ]
    Compliance will be tracked using training diaries. The number of training diaries and prescribed exercise sessions completed, and days in adherence with activity modification guidelines will be recorded. Compliance rates will be reported as a percentage, relative to the participants duration of participation in the study.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
  • PROMIS Pediatric Global Health questionnaire [ Time Frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks ]
    The PROMIS Pediatric Global Health questionnaire will be used to assess self-reported impact of injury on mental and physical health. Raw scores range from 7-35, where higher scores indicate higher physical and mental health.
  • PROMIS Pediatric Physical Activity Short Form questionnaire [ Time Frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks ]
    The PROMIS Pediatric Physical Activity Short Form questionnaire will be used to assess self-reported capability over a 7 day period. Raw scores range from 8-40, where a higher score indicates higher physical activity levels.
  • The Foot and Ankle Outcomes Score (FAOS) [ Time Frame: Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks ]
    Three subscales from The Foot and Ankle Outcomes Score (FAOS) will be used to measure foot and ankle-related quality of life (FOAS-QoL), symptoms (FAOS-S), and function in sport and recreation. Each subscale ranges from 0-100, where higher scores indicate better outcomes.
  • The Fear of Pain Questionnaire Child Report (FOBQC) [ Time Frame: Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks ]
    The Fear of Pain Questionnaire Child Report (FOBQC) will assess fear of pain and avoidance of activities. Scores range from 0-96, where 0-34 indicates low fear and 51-96 indicates high fear.
  • The Global Rating of Change (GROC) scale [ Time Frame: Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks ]
    The Global Rating of Change (GROC) scale, will be used to measure their satisfaction and perceived recovery of their child using a 10-point likert respectively ranging from -5 to +5 indicating a range between "not satisfied" to "very satisfied" and "much worse" to "much improved".
  • PROMIS Parent Proxy Pain Intensity questionnaire [ Time Frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks ]
    PROMIS Parent Proxy Pain Intensity will assess symptom severity from the parent's perspective. Parents are asked to rate their child's pain at it's worst on a scale of 0-10, where 0 is "no pain" and 10 is "worst pain imaginable".
  • PROMIS Parent Proxy Pain Interference questionnaire [ Time Frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks ]
    The PROMIS Parent Proxy Pain Interference Scale assesses symptom severity and pain with daily activity from the parent's perspective. Raw scores range from 8-40, where lower scores indicate less pain interference.
  • PROMIS Parent Proxy Global Health questionnaire [ Time Frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks ]
    The PROMIS Parent Proxy Global Health questionnaire will assess the parent's perspective on the participant's mental and physical health. Raw scores range from 7-35, where higher scores indicate higher physical and mental health.
  • PROMIS Parent Proxy Physical Activity questionnaire [ Time Frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks ]
    The PROMIS Parent Proxy Physical Activity form will be used to assess parent-reported capability of their child's physical activities over a 7 day period. Raw scores range from 4-20, where a higher score indicates higher physical activity level.
  • Fear of Pain Questionnaire Parent Report (FOBQP) [ Time Frame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks ]
    The Fear of Pain Questionnaire Parent Report (FOBQP) is a parent inventory to assess child pain-related fears. Scores range from 0-96, where 0-34 indicates low fear and 51-96 indicates high fear.
  • Ankle range of motion [ Time Frame: Change over time with evaluations at baseline, 4-weeks, 8-weeks,10-weeks, and 12-weeks ]
    Ankle range of motion in non-weight bearing and weight bearing positions will be measured with a goniometer.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heel Pain in Adolescents: A Pilot Study on the Effectiveness of Exercise Therapy and Activity Modification
Official Title  ICMJE Heel Pain in Adolescents: A Pilot Study on the Effectiveness of Exercise Therapy and Activity Modification
Brief Summary Invesigators plan to conduct a 12-week longitudinal cohort study of 30 subjects with calcaneal apophysitis. Subjects will be included if they are between 7-17 years-old, have experienced an insidious onset of heel pain with running or jumping activities, and have no underlying diagnosis predisposing heel pain and no other injury that limits their ability to run and jump. Parents of subjects will be invited to participate by completing questionnaires related to their perspective of their child's symptoms, physical activity level, quality of life, and their satisfaction with the treatment protocol. Subjects will be asked to attend 4 monthly sessions consisting of evaluation and treatment.
Detailed Description Investigators will recruit 30 subjects between ages 7-17 with heel pain and also invite their parent/guardian to participate in this research study. Participants will be evaluated at baseline, 4-weeks, 8-weeks and 12-weeks. Data collections at each assessment visit will be identical except for the baseline visit. The baseline evaluation will consist of questionnaires related to past medical history in addition to all other procedures. All evaluations will include patient-reported outcome measures, clinical measures, and measurement of tendon structure, mechanical properties, and muscle-tendon function Treatment sessions will occur immediately following the evaluation sessions (4 total). During treatment sessions, participants will be provided with education, therapeutic exercise instruction, and discussion of their training diary and home exercise program. Treatment sessions will last 30-45 minutes. In addition to the 4 in-person treatment sessions, virtual visits will take place 2 weeks in between each in-person visits, (one virtual visit maximum every 4 weeks) as needed. Virtual visits will be no longer than 30 minutes to discuss patient needs.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sever's Disease
  • Achilles Tendinopathy
  • Insertional Achilles Tendinopathy
  • Apophysitis; Calcaneus
Intervention  ICMJE Other: Exercise Therapy and Activity Modification
Daily lower leg strengthening exercises Therapy and pain-guided activity modification.
Study Arms  ICMJE Experimental: Exercise and Activity Modification
Intervention: Other: Exercise Therapy and Activity Modification
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 24, 2021)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 25, 2022
Estimated Primary Completion Date August 25, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Insidious onset of heel pain with running or jumping activities lasting at least three weeks
  • Location of pain is focal at the calcaneus over the Achilles tendon attachment and/or the Achilles tendon

Exclusion Criteria:

  • Subjects having an underlying diagnosis predisposing to heel pain (spina bifida, osteogenesis imperfecta, Larsen syndrome, cerebral palsy)
  • History of calcaneal fracture or foot/ankle surgery in the past 6 months
  • Another injury that limits the ability to perform exercises on the injured leg
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karin G Silbernagel, PhD 302-831-4808 kgs@udel.edu
Contact: Shawn L Hanlon, MS 302-831-3145 hanlon@udel.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04816188
Other Study ID Numbers  ICMJE 1652996
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Karin Silbernagel, University of Delaware
Study Sponsor  ICMJE University of Delaware
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Delaware
Verification Date April 2021

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