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

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University of Delaware

Status

Completed

Conditions

Insertional Achilles Tendinopathy
Sever's Disease
Apophysitis; Calcaneus
Achilles Tendinopathy

Treatments

Other: Exercise Therapy and Activity Modification

Study type

Interventional

Funder types

Other

Identifiers

NCT04816188
1652996

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

7 to 17 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

Exercise and Activity Modification
Experimental group
Treatment:
Other: Exercise Therapy and Activity Modification

Trial contacts and locations

1

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Central trial contact

Karin G Silbernagel, PhD; Shawn L Hanlon, MS

Data sourced from clinicaltrials.gov

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