Recruiting
Phase 2

Exercise Therapy

Sponsor:

California State University, Fullerton

Code:

NCT07928232

Conditions

Apophysitis; Calcaneus

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

Exercise

Active Control

Study Details

Brief summary:

Sever's disease is an overuse injury to the calcaneal growth plate caused by repetitive traction stress from the Achilles tendon in youth. Limited evidence exists to guide effective treatment for Sever's disease and disrupt short- and long-term pain and disability. Exercise therapy has the strongest evidence to promote tissue healing and is supported for other growth plate injuries. This study aims to determine if a comprehensive exercise therapy and activity modification intervention produces a clinically meaningful improvement in (Aim 1) pain and lower extremity function, (Aim 2) muscle and tendon structure, and (Aim 3) physical activity, compared to a non-exercise palliative approach for patients with Sever's disease. Differences between groups after completing 12 weeks of intervention.

Conditions

Apophysitis; Calcaneus

Study ID

NCT07928232

Start date

Oct 30, 2025

Status verified date

Jul, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Insidious onset of heel pain over several weeks
  • Pain on palpation of the calcaneus or Achilles tendon
  • Complaint of heel pain with running or jumping activities.

Exclusion Criteria:

  • Any underlying condition predisposing heel pain (i.e., spina bifida, osteogenesis imperfecta, Larsen syndrome, cerebral palsy)
  • Any other injury that limits their ability to run or jump.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Group

The experimental group will receive supervised progressive tendon-loading exercise therapy, pain-guided activity modification education, and feedback on daily activity. Both groups will receive gel heel cushion inserts for footwear.

active comparator: Control Group

The control group will not receive progressive tendon-loading exercise. The control group will receive the same education as the experimental group, except the control group will be asked to participate in activities as tolerated and rest as needed. The control group will be asked to record the same activity diary as the experimental group, but will not receive feedback on their daily activity. Both groups will receive gel heel cushion inserts for footwear.

Interventions

Exercise

Therapeutic Achilles-tendon loading exercise; Activity modification using a Pain Monitoring Model

Active Control

Conventional Clinician advice for pediatric overuse injury management.

Primary outcome measure

  • Self-reported Achilles tendon or heel pain and Symptoms with Activity [ Time Frame: Baseline, 6 weeks, and 12 weeks after randomization. ]

Central Contacts and Locations

Central contacts

Shawn L Hanlon, PhD

657-278-5869shanlon@fullerton.edu

Locations

Kinesiology and Health Sciences Building

Recruiting

Fullerton, California, United States, 92831

Contacts

Shawn L Hanlon, PhD

657-278-3316shanlon@fullerton.edu

shawnhanlon90@gmail.com

Principal Investigator:

Shawn L Hanlon, PhD

More Information

Sponsor

California State University, Fullerton

Last update posted

Nov 10, 2026

Last verified

Jul, 2026

Keywords

  • Achilles tendon
  • ultrasound
  • elastography
  • therapeutic exercise
  • rehabilitation
  • apophysitis
  • Sever's Disease
  • growth plate
  • overuse injury
  • adolescent
  • pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by California State University, Fullerton on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.