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

NCT ID: NCT04816188

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2023-07-25

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise and Activity Modification

Group Type: EXPERIMENTAL

Exercise Therapy and Activity Modification

Intervention Type: OTHER

Daily lower leg strengthening exercises Therapy and pain-guided activity modification.

Interventions

Exercise Therapy and Activity Modification

Daily lower leg strengthening exercises Therapy and pain-guided activity modification.

Intervention Type: OTHER

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Karin Silbernagel

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

STAR Building

Newark, Delaware, United States

Countries

United States

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Other Identifiers

1652996

Identifier Type: -

Identifier Source: org_study_id