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

NCT04816188 | Completed

• 1 other identifier: 1652996
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Achilles tendon; Pain; Activity modification; Sever's disease; Achilles tendinopathy; Apophysitis; Exercise

Outcome Measures

Primary Outcomes (6)

• 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.

  Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks

• 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.

  Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks

• 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.

  Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks

• 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.

  Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks

• 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.

  Change over time with evaluations at baseline, 2-weeks, 4-weeks, 8-weeks, and 12-weeks

• 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.

  Average compliance rate for each group over first year of study recruitment

Secondary Outcomes (11)

• PROMIS Pediatric Global Health questionnaire

  Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks

• PROMIS Pediatric Physical Activity Short Form questionnaire

  Change over time with evaluations at baseline, 2-weeks, 4-weeks, 6-weeks, 8-weeks,10-weeks and 12-weeks

• The Foot and Ankle Outcomes Score (FAOS)

  Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks

• The Fear of Pain Questionnaire Child Report (FOBQC)

  Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks

• The Global Rating of Change (GROC) scale

  Change over time with evaluations at baseline, 2-weeks, 4-weels, 6-weeks, 8-weeks,10-weeks and 12-weeks

Study Arms (1)

Exercise and Activity Modification

EXPERIMENTAL

Other: Exercise Therapy and Activity Modification

Interventions

Exercise Therapy and Activity Modification OTHER

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

Exercise and Activity Modification

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

STAR Building

Newark, Delaware, 19713, United States

Location

Related Publications (12)

• 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.

  PMID: 21654464 BACKGROUND

• 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.

  PMID: 11579069 BACKGROUND

• 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.

  PMID: 30649907 BACKGROUND

• 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.

  PMID: 31095417 BACKGROUND

• 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.

  PMID: 24264804 BACKGROUND

• 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.

  PMID: 11642530 BACKGROUND

• Simons LE, Sieberg CB, Carpino E, Logan D, Berde C. The Fear of Pain Questionnaire (FOPQ): assessment of pain-related fear among children and adolescents with chronic pain. J Pain. 2011 Jun;12(6):677-86. doi: 10.1016/j.jpain.2010.12.008. Epub 2011 Feb 26.

  PMID: 21354866 BACKGROUND

• 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.

  PMID: 27331037 BACKGROUND

• Zellers JA, Bley BC, Pohlig RT, Alghamdi NH, Silbernagel KG. FREQUENCY OF PATHOLOGY ON DIAGNOSTIC ULTRASOUND AND RELATIONSHIP TO PATIENT DEMOGRAPHICS IN INDIVIDUALS WITH INSERTIONAL ACHILLES TENDINOPATHY. Int J Sports Phys Ther. 2019 Sep;14(5):761-769.

  PMID: 31598414 BACKGROUND

• Cortes DH, Suydam SM, Silbernagel KG, Buchanan TS, Elliott DM. Continuous Shear Wave Elastography: A New Method to Measure Viscoelastic Properties of Tendons in Vivo. Ultrasound Med Biol. 2015 Jun;41(6):1518-29. doi: 10.1016/j.ultrasmedbio.2015.02.001. Epub 2015 Mar 19.

  PMID: 25796414 BACKGROUND

• Silbernagel KG, Gustavsson A, Thomee R, Karlsson J. Evaluation of lower leg function in patients with Achilles tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2006 Nov;14(11):1207-17. doi: 10.1007/s00167-006-0150-6. Epub 2006 Jul 21.

  PMID: 16858560 BACKGROUND

• Silbernagel KG, Thomee R, Eriksson BI, Karlsson J. Continued sports activity, using a pain-monitoring model, during rehabilitation in patients with Achilles tendinopathy: a randomized controlled study. Am J Sports Med. 2007 Jun;35(6):897-906. doi: 10.1177/0363546506298279. Epub 2007 Feb 16.

  PMID: 17307888 BACKGROUND

MeSH Terms

Conditions

Pain; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 25, 2021
• Study Start: March 15, 2021
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)