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

Primary Purpose

Sever's Disease, Achilles Tendinopathy, Insertional Achilles Tendinopathy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Therapy and Activity Modification
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sever's Disease focused on measuring Achilles tendon, Pain, Activity modification, Sever's disease, Achilles tendinopathy, Apophysitis, Exercise

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • STAR BuildingRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise and Activity Modification

Arm Description

Outcomes

Primary Outcome Measures

Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire
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
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
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
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
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
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.

Secondary Outcome Measures

PROMIS Pediatric Global Health questionnaire
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
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)
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)
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
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
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
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
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
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)
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
Ankle range of motion in non-weight bearing and weight bearing positions will be measured with a goniometer.

Full Information

First Posted
March 18, 2021
Last Updated
November 10, 2022
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT04816188
Brief Title
Heel Pain in Adolescents: A Pilot Study on the Effectiveness of Exercise Therapy and Activity Modification
Official Title
Heel Pain in Adolescents: A Pilot Study on the Effectiveness of Exercise Therapy and Activity Modification
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
May 25, 2023 (Anticipated)
Study Completion Date
July 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sever's Disease, Achilles Tendinopathy, Insertional Achilles Tendinopathy, Apophysitis; Calcaneus
Keywords
Achilles tendon, Pain, Activity modification, Sever's disease, Achilles tendinopathy, Apophysitis, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise and Activity Modification
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Exercise Therapy and Activity Modification
Intervention Description
Daily lower leg strengthening exercises Therapy and pain-guided activity modification.
Primary Outcome Measure Information:
Title
Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire
Description
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.
Time Frame
Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Scale
Description
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.
Time Frame
Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
Title
Tendon Structure
Description
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.
Time Frame
Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks
Title
Tendon Mechanical Properties
Description
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.
Time Frame
Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks
Title
Muscle-Tendon Function
Description
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.
Time Frame
Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks
Title
Compliance
Description
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.
Time Frame
Average compliance rate for each group over first year of study recruitment
Secondary Outcome Measure Information:
Title
PROMIS Pediatric Global Health questionnaire
Description
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.
Time Frame
Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
Title
PROMIS Pediatric Physical Activity Short Form questionnaire
Description
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.
Time Frame
Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
Title
The Foot and Ankle Outcomes Score (FAOS)
Description
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.
Time Frame
Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks
Title
The Fear of Pain Questionnaire Child Report (FOBQC)
Description
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.
Time Frame
Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks
Title
The Global Rating of Change (GROC) scale
Description
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".
Time Frame
Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks
Title
PROMIS Parent Proxy Pain Intensity questionnaire
Description
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".
Time Frame
Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
Title
PROMIS Parent Proxy Pain Interference questionnaire
Description
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.
Time Frame
Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
Title
PROMIS Parent Proxy Global Health questionnaire
Description
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.
Time Frame
Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
Title
PROMIS Parent Proxy Physical Activity questionnaire
Description
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.
Time Frame
Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
Title
Fear of Pain Questionnaire Parent Report (FOBQP)
Description
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.
Time Frame
Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
Title
Ankle range of motion
Description
Ankle range of motion in non-weight bearing and weight bearing positions will be measured with a goniometer.
Time Frame
Change over time with evaluations at baseline, 4-weeks, 8-weeks,10-weeks, and 12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karin G Silbernagel, PhD
Phone
302-831-4808
Email
kgs@udel.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shawn L Hanlon, MS
Phone
302-831-3145
Email
hanlon@udel.edu
Facility Information:
Facility Name
STAR Building
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin G Silbernagel, PhD
Phone
302-831-4808
Email
kgs@udel.edu
First Name & Middle Initial & Last Name & Degree
Shawn Hanlon, MS
Phone
8564041322
Ext
Hanlon
Email
hanlon@udel.edu
First Name & Middle Initial & Last Name & Degree
Shawn L Hanlon, MS
First Name & Middle Initial & Last Name & Degree
Karin G Silbernagel, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21654464
Citation
Rachel JN, Williams JB, Sawyer JR, Warner WC, Kelly DM. Is radiographic evaluation necessary in children with a clinical diagnosis of calcaneal apophysitis (sever disease)? J Pediatr Orthop. 2011 Jul-Aug;31(5):548-50. doi: 10.1097/BPO.0b013e318219905c.
Results Reference
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Citation
Robinson JM, Cook JL, Purdam C, Visentini PJ, Ross J, Maffulli N, Taunton JE, Khan KM; Victorian Institute Of Sport Tendon Study Group. The VISA-A questionnaire: a valid and reliable index of the clinical severity of Achilles tendinopathy. Br J Sports Med. 2001 Oct;35(5):335-41. doi: 10.1136/bjsm.35.5.335.
Results Reference
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Citation
Suryavanshi JR, Goto R, Jivanelli B; PRiSM Outcomes Measures Research Interest Group; Aberdeen J, Duer T, Lam KC, Franklin CC, MacDonald J, Shea KG, Fabricant PD. Age-Appropriate Pediatric Sports Patient-Reported Outcome Measures and Their Psychometric Properties: A Systematic Review. Am J Sports Med. 2019 Nov;47(13):3270-3276. doi: 10.1177/0363546518818822. Epub 2019 Jan 16.
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PubMed Identifier
31095417
Citation
Rathleff MS, Graven-Nielsen T, Holmich P, Winiarski L, Krommes K, Holden S, Thorborg K. Activity Modification and Load Management of Adolescents With Patellofemoral Pain: A Prospective Intervention Study Including 151 Adolescents. Am J Sports Med. 2019 Jun;47(7):1629-1637. doi: 10.1177/0363546519843915. Epub 2019 May 16.
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PubMed Identifier
24264804
Citation
Forrest CB, Bevans KB, Pratiwadi R, Moon J, Teneralli RE, Minton JM, Tucker CA. Development of the PROMIS (R) pediatric global health (PGH-7) measure. Qual Life Res. 2014 May;23(4):1221-31. doi: 10.1007/s11136-013-0581-8. Epub 2013 Nov 22.
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Citation
Roos EM, Brandsson S, Karlsson J. Validation of the foot and ankle outcome score for ankle ligament reconstruction. Foot Ankle Int. 2001 Oct;22(10):788-94. doi: 10.1177/107110070102201004.
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Silbernagel KG, Shelley K, Powell S, Varrecchia S. Extended field of view ultrasound imaging to evaluate Achilles tendon length and thickness: a reliability and validity study. Muscles Ligaments Tendons J. 2016 May 19;6(1):104-10. doi: 10.11138/mltj/2016.6.1.104. eCollection 2016 Jan-Mar.
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Heel Pain in Adolescents: A Pilot Study on the Effectiveness of Exercise Therapy and Activity Modification

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