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Heavy-slow Resistance Training and Ultrasound-guided Corticosteroid Injection in Plantar Fasciopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03535896
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Henrik Riel, Aalborg University

Brief Summary:
The purpose of this study is to investigate the feasibility of combining heavy-slow resistance training with an ultrasound-guided corticosteroid injection to reduce pain in individuals with plantar fasciopathy. Feasibility will be evaluated using the acceptability of the combined interventions and exercise compliance.

Condition or disease Intervention/treatment Phase
Plantar Heel Pain Plantar Fasciopathy Other: HSR Drug: Corticosteroid injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Heavy-slow Resistance Training in Addition to an Ultrasound-guided Corticosteroid Injection to Reduce Pain in Individuals With Plantar Fasciopathy: a Feasibility Study
Actual Study Start Date : June 8, 2018
Actual Primary Completion Date : October 11, 2018
Actual Study Completion Date : October 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids Ultrasound

Arm Intervention/treatment
Experimental: HSR and injection
HSR and corticosteroid injection
Other: HSR

Participants will complete a heel raise standing with the forefoot on a step. The toes are maximally dorsiflexed by placing a towel underneath them. The heel raise is performed with a raise to maximal plantar flexion and to maximal dorsi flexion.

The exercise is performed with a load as heavy as possible but no heavier than 8RM and for as many sets as possible every other day.


Drug: Corticosteroid injection
Participants receive an ultrasound-guided corticosteroid injection between 5 and 8 days after baseline. A 21-gauge, 40 mm needle is connected to a 2.5 cm3 syringe filled with 1 ml Triamcinolonhexacetonid (Lederspan, Meda) + 1 ml Lidocain 10 mg7ml (Xylocain, AstraZeneca). The skin is cleansed with Chlorhexidine alcohol 0.5 % (Medic). The needle is inserted with a medial approach under ultrasound-guidance aligned to the long axis of the ultrasound transducer. The injection is placed anterior to the plantar fascia insertion on the calcaneal bone in the region of maximal fascia thickness.




Primary Outcome Measures :
  1. Acceptability [ Time Frame: At the 8-week follow-up ]
    Acceptability of the combined interventions measured by a participant acceptability questionnaire that includes a 7-point Likert scale ranging from "very unacceptable" to "very acceptable". This is not a measure of whether the participant's symptoms have improved to a point where they are recovered or feel close to recovery but if it matches their expectations to the content of the intervention and acceptability of performing exercise after receiving an injection. This will be clearly stated on the questionnaire to emphasise that improvement is not to be considered. The combined interventions are categorised as "unacceptable" if they are rated as "very unacceptable" or "unacceptable" (category 1-2) and categorised as "acceptable" if they are rated from "slightly unacceptable" to "very acceptable" (category 3-7).

  2. Compliance [ Time Frame: From baseline to the 8-week follow-up ]
    Compliance to the exercises as measured by the mean number of training sessions performed per week throughout the intervention measured by a training diary that each participant is handed out at baseline. The participants will be instructed in filling out the number of repetitions and sets performed and the day on which they performed the exercise

  3. Recruitment rate [ Time Frame: From start of recruitment until the 20th participant has been recruited, assessed up to 12 months ]
    Mean number of participants recruited per week

  4. Exercise start [ Time Frame: From date of injection to exercise start assessed up to 8 weeks ]
    Mean days until the participant starts to perform the exercises from the two days after the injection based on training diary data. Participants are asked to start performing the exercise as soon as they feel ready but not before two days after the injection.


Secondary Outcome Measures :
  1. Change in Foot Health Status Questionnaire [ Time Frame: At baseline and at the 4- and 8-week follow-ups ]
    Ranging from 0 (poor foot health) to 100 (optimum foot health)

  2. Change in mean daily heel pain measured on an 11-point Numerical Rating Scale (NRS) [ Time Frame: From baseline to one week after injection ]
    Participants receive a daily SMS asking them to rate their mean heel pain during the past 24 hours on an NRS (ranging from 0 (no pain) to 10 (worst pain imaginable)) from the day after baseline to one week after the injection

  3. Global Rating of Change [ Time Frame: At the 8-week follow-up ]
    This will be used to measure the participants' self-reported recovery on a 7-point Likert scale ranging from "much improved" to "much worse". Participants are categorised as improved if they rate themselves as "much improved" or "improved" (category 6-7) and categorised as not improved if they rate themselves from "slightly improved" to "much worse" (category 1-5).

  4. Change in plantar fascia thickness [ Time Frame: At baseline and at the 8-week follow-up ]
    Measured in millimeters using ultrasonography

  5. Change in Pain Self-Efficacy Questionnaire score [ Time Frame: At baseline and at the 4- and 8-week follow-ups ]
    The Pain Self-Efficacy Questionnaire ranges from 0 (not at all confident) to 60 (completely confident) with lower scores indicating lower self-efficacy. A Danish translation of the original questionnaire, which has been validated in a Danish chronic pain population, will be used.

  6. Change in physical activity level [ Time Frame: At baseline and at the 4- and 8-week follow-ups ]
    This will be measured using the International Physical Activity Questionnaire short form (IPAQ). A Danish translation of the original questionnaire will be used. The IPAQ is the most commonly used questionnaire for measuring physical activity among adults and consists of 9 items that provide information on the time spent performing vigorous and moderate activities, the time spent walking, and time spent sedentary during the past week. The IPAQ gives an estimate of the total weekly physical activity measured in MET-minutes per week and total minutes spent sitting



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of inferior heel pain for at least three months before enrolment
  • Pain on palpation of the medial calcaneal tubercle or the proximal plantar fascia
  • Thickness of the plantar fascia of 4 mm or greater
  • Mean heel pain of 30 mm or above on a 0 to 100 mm VAS during the previous week

Exclusion Criteria:

  • Below 18 years of age
  • History of inflammatory systemic diseases
  • Prior heel surgery
  • Pregnancy
  • Pain or stiffness in the 1st metatarsophalangeal joint to an extent where the exercises cannot be performed
  • Corticosteroid injection for plantar fasciopathy within the previous six months
  • Known hypersensitivity to corticosteroids or local anaesthetics
  • Skin or soft tissue infection near the injection site

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535896


Locations
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Denmark
Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University
Aalborg, Denmark, 9220
Sponsors and Collaborators
Aalborg University
Investigators
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Principal Investigator: Henrik Riel, MSc Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Henrik Riel, PhD student, Aalborg University
ClinicalTrials.gov Identifier: NCT03535896    
Other Study ID Numbers: 2018-521-0008
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No