Clinical trial NCT04816188: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sever's Disease
Achilles Tendinopathy
Insertional Achilles Tendinopathy
Apophysitis; Calcaneus
Keywords: Achilles tendon
Pain
Activity modification
Sever's disease
Achilles tendinopathy
Apophysitis
Exercise
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 13
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Victorian Institute of Sport Assessment - Achilles (VISA-A) questionnaire
timeFrame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Pain Interference Scale
timeFrame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
measure: Tendon Structure
timeFrame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks
measure: Tendon Mechanical Properties
timeFrame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks
measure: Muscle-Tendon Function
timeFrame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks
measure: Compliance
timeFrame: Average compliance rate for each group over first year of study recruitment
Secondary outcomes:
measure: PROMIS Pediatric Global Health questionnaire
timeFrame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
measure: PROMIS Pediatric Physical Activity Short Form questionnaire
timeFrame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
measure: The Foot and Ankle Outcomes Score (FAOS)
timeFrame: Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks
measure: The Fear of Pain Questionnaire Child Report (FOBQC)
timeFrame: Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks
measure: The Global Rating of Change (GROC) scale
timeFrame: Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks
measure: PROMIS Parent Proxy Pain Intensity questionnaire
timeFrame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
measure: PROMIS Parent Proxy Pain Interference questionnaire
timeFrame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
measure: PROMIS Parent Proxy Global Health questionnaire
timeFrame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
measure: PROMIS Parent Proxy Physical Activity questionnaire
timeFrame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
measure: Fear of Pain Questionnaire Parent Report (FOBQP)
timeFrame: Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks
measure: Ankle range of motion
timeFrame: Change over time with evaluations at baseline, 4-weeks, 8-weeks,10-weeks, and 12-weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: STAR Building
state: Delaware
Study officials:
References:
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.
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