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Trial record 25 of 1045 for:    scale | Norway

Plantar Fasciopathy and the Effectiveness of Radial Extracorporeal Shockwave Therapy, Physical Training or Usual Care

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ClinicalTrials.gov Identifier: NCT03472989
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Marte Heide, MD, Oslo University Hospital

Brief Summary:

The purpose of this study is to evaluate whether radial extracorporeal shockwave therapy (rESWT), sham rESWT or standardized exercise program is more effective on heel pain than usual care in the treatment of plantar fasciopathy.

The null hypothesis is: There is no difference between rESWT, sham- rESWT or standardized exercise program on change in heel pain compared to usual care in the treatment of plantar fasciopathy at 6 months follow-up.

Alternative hypothesis is:

H1: There is a difference between rESWT and usual care on change in heel pain at 6 months follow-up.

H2: There is a difference between sham-rESWT and usual care on change in heel pain at 6 months follow-up.

H3: There is a difference between standardized exercise program and usual care on change in heel pain at 6 months follow- up.

We will perform a subgroup analysis on the patients who have no previous experience in receiving rESWT.


Condition or disease Intervention/treatment Phase
Plantar Fascitis Device: Radial extracorporeal shock wave Device: Sham-radial extracorporeal shock wave Behavioral: Standardized high-load exercise program Behavioral: Usual care Not Applicable

Detailed Description:

Plantar fasciopathy is a common cause of plantar heel pain, with prevalence up to 10%. The condition is reported to be self-limiting, but about 20% experience long-term symptoms with duration over 3 months. Radial extracorporeal shock wave therapy (rESWT), exercise and foot orthosis are common modalities suggested in the treatment of plantar fasciopathy. Several trials have investigated the effectiveness of these modalities, but due to methodological limitations the evidence is sparse. To our knowledge there is still no agreement on which conservative treatment modality to recommend. The usual care at our outpatient clinic is information on the pathogenesis, etiology and prognosis. We give advice on using proper footwear, including orthosis and to accept pain to a certain level during activity.

We therefore want to evaluate whether radial extracorporeal shockwave therapy (rESWT), sham rESWT or standardized exercise program is more effective on heel pain than usual care in the treatment of plantar fasciopathy.

This study is a double-blind randomized sham-controlled trial where the patients are randomly allocated in 1:1 ratio to receive one of the four treatments: rESWT, sham-rESWT, standardized exercise og usual care. All the patients regardless of group allocation will receive standardized information (oral and written) on the condition and get custom made foot orthosis made by an orthopedic technician at Sophies Minde AS.

The patients are blinded for rESWT/sham-rESWT, whereas blinding of the exercise group and usual care group is not possible. To evaluate the blinding of the rESWT, the patients are asked after the last treatment whether they believe that they have received real rESWT, sham-rESWT or if they do not know.

The patients will have follow-up at 3 months, 6 months and 12 months. The main outcome is change in heel pain (NRS) during activity at 6 months. We will also perform analysis regarding secondary outcome as stated below, and evaluate predictive factors. Patients in the rESWT group/sham- rESWT group not receiving at least 3 shock wave treatments are regarded as non-adherence. Patients in the exercise group not attending 6 of 8 sessions with the physiotherapist or not completing 30 of 36 exercise sessions (3 sessions per week, 12 weeks) are regarded as non-adherence. They will be included in the intention-to-treat analysis. There will also be a separate intention-to- treat analysis with only adherent patients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to one of the four intervention groups in parallell for the duration of the study.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The patients who receive rESWT or sham-rESWT will be blinded.
Primary Purpose: Treatment
Official Title: The Effectiveness of Radial Extracorporeal Shockwave Therapy (rESWT), Sham- rESWT, Standardized Exercise Program or Usual Care for Patients With Plantar Fasciopathy. Study Protocol for a Double-blind, Randomized Sham- Controlled Trial
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Radial extracorporeal shock wave
Active shock wave treatment. All patients will get standardized information and custom made foot orthosis.
Device: Radial extracorporeal shock wave

Patients will receive treatment once a week for 3 weeks. Treatment will be administered by using the rESWT device named Swiss DolorClast (EMS). 2000 impulses are implied via the power hand piece to the area of max tenderness at the insertion of the plantar fascia, with a pressure of 1.5-3 bars depending on what the patient tolerates. The treatments will be given by a trained physiotherapist at our Department.

Patients will also receive standardized information at baseline, and will get custom made foot orthosis.


Sham Comparator: Sham-radial extracorporeal shock wave
Sham- shock wave treatment. All patients will get standardized information and custom made foot orthosis.
Device: Sham-radial extracorporeal shock wave

Patients will receive the same treatment as the patients in the Group receiving real shock waves, but no real shock waves are conducted. The probe is similar in design, sound and shape.

Patients will also receive standardized information at baseline, and will get custom made foot orthosis.


Active Comparator: Standardized high-load exercise program
High-load exercise treatment. All patients will get standardized information and custom made foot orthosis.
Behavioral: Standardized high-load exercise program

Patients will be instructed to do 2 exercises: "Unilateral heel raise" and "unilateral leg squat" three times a week for 12 weeks. The patients will have a total of 8 sessions supervised by a physiotherapist at our Department.

Patients will also receive standardized information at baseline, and will get custom made foot orthosis.


Active Comparator: Usual care
Only standardized information and custom made foot orthosis
Behavioral: Usual care
Patients will get standardized information as in the other three intervention groups with information on pathogenesis, etiology and prognosis, and they will get custom made foot orthosis




Primary Outcome Measures :
  1. Numeric rating scale (NRS) [ Time Frame: 6 months ]
    Change in heel pain (during activity the last week ). Numeric rating scale is a patient reported pain intensity scale ranging from 0 (no pain) to 10 (worst possible pain).


Secondary Outcome Measures :
  1. Foot Functional Index, revised, short Version (FFI-RS) [ Time Frame: 6 and 12 months ]
    Change in Foot Health status. Consists of 34 questions.

  2. RAND- 12 [ Time Frame: 6 and 12 months ]
    Health related quality of life. 12 items.

  3. Ultrasound scanning thickness measure [ Time Frame: 6 and 12 months ]
    Thickness in millimeters, at the insertion of the fascia to calcaneus

  4. Ultrasound findings: hypoechoic changes [ Time Frame: 6 and 12 months ]
    Presence or not of hypoechoic changes

  5. Ultrasound findings: Vascularisation [ Time Frame: 6 and 12 months ]
    Presence or not of vascularisation

  6. Ultrasound findings: Calcification [ Time Frame: 6 and 12 months ]
    Presence or not of calcification

  7. Numeric rating scale (NRS) [ Time Frame: 6 and 12 months ]
    Change in heel pain (in rest the last week). Numeric rating scale is a patient reported pain intensity scale ranging from 0 (no pain) to 10 (worst possible pain).

  8. Numeric rating scale (NRS) [ Time Frame: 12 months ]
    Change in heel pain (in activity the last week).Numeric rating scale is a patient reported pain intensity scale ranging from 0 (no pain) to 10 (worst possible pain).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pain with duration > 3 months localized in the proximal insertion of the plantar fascia on the medial calcaneal tuberosity.

Only patients with reported pain NRS 3 or more at activity at baseline, will be included in the trial.

  • Tenderness to palpation corresponding to the painful area.
  • Be residents of Norway, understand oral and written Norwegian.

Exclusion Criteria:

  • Treatment with radial extracorporeal shock wave therapy the last 3 months.
  • Spondylarthropathy or rheumatoid arthritis.
  • Plantar fibromatosis.
  • Tarsal tunnel syndrome.
  • Polyneuropathy.
  • Previous surgery with remaining osteosynthesis material in the foot or ankle.
  • Contraindications for shock wave therapy ( use of anticoagulant drugs, pregnancy, bleeding disorders, epilepsy or pacemaker)

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): NCT03472989


Contacts
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Contact: Marte Heide, MD +4790125116 marte.heide@medisin.uio.no
Contact: Aasne Fenne Hoksrud, MD, PhD +4747417204 aahoks@ous-hf.no

Locations
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Norway
Oslo University Hospital, Ullevål Recruiting
Oslo, Norway, 0450
Contact: Marte Heide, MD    +4790125116    marte.heide@medisin.uio.no   
Contact: Aasne Hoksrud, MD, PhD    +4747417204    aahoks@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Study Director: Aasne Fenne Hoksrud, MD, PhD Oslo University hospital, Department of Physical Medicine and Rehabilitation

Publications:

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Responsible Party: Marte Heide, MD, Medical doctor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03472989     History of Changes
Other Study ID Numbers: 2017/1325
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marte Heide, MD, Oslo University Hospital:
plantar fasciopathy
foot orthosis
rESWT
exercise
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases