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Plantar Heel Pain: Multisegment Foot Motion and Muscle Function, FFI Translation, and Evaluation of Treatments (Subproject1) Effectiveness of Strengthening Exercise Program on Symptoms in Patients With PHP (Subproject3)

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ClinicalTrials.gov Identifier: NCT03161314
Recruitment Status : Completed
First Posted : May 19, 2017
Last Update Posted : October 16, 2019
Sponsor:
Collaborator:
Thailand Research Fund
Information provided by (Responsible Party):
Sunee Bovonsunthonchai, Mahidol University

Brief Summary:

(Subproject 1) "Plantar heel pain (PHP)" or "plantar fasciitis" is one of the major foot problems which can occur in any age group. It is a commonly encountered musculoskeletal problem that can cause disability, activity limitation, discomfort, and affect the quality of life. It involves pain and inflammation of the plantar fascia, which runs across the bottom of the foot and connects the heel bone to toes. PHP frequently found in active workers aged between 25 and 65 years with the highest incidence in people aged between 40 and 60 years.

However, very few studies investigated the alterations of the multisegmental foot motions and muscle functions in patients with PHP. To prescribe the relevant program of treatment and reduce the risk of symptoms chronicity, it is necessary to have an in-depth understanding of changing mechanisms in patients with PHP. To explain how the symptoms occur in patients with PHP, foot function is another aspect that should be determined. One of the popular questionnaires determining foot function is the Foot Function Index (FFI) questionnaire. It has been proved to have good reliability and validity and has been translated into several languages. To be able to use the international standard questionnaire, it is necessary to translate the FFI into Thai. This can be implemented in Thailand and be able to compare the findings of the interventional effect internationally. In addition, very few studies reported the effectiveness of the treatment program for patients with PHP. Among previous evidences, the controversial findings existed. Thus, the intervention program should be evaluated for obtaining the effective treatment for this population.

(Subproject 3) The objectives of the study will be General Objective is to investigate the effectiveness of strengthening exercise program on symptoms in patients with plantar heel pain.

Specific Objectives is to compare the effectiveness between physical therapy treatment program with strengthening exercise and with stretching exercise on foot function score, pain at worst score, plantar fascia thickness, muscles strength, ankle motion, and gait parameters in patients with plantar heel pain among baseline, after 4th and 8th of treatments, and after 1st and 2nd month of self-home based exercise.


Condition or disease Intervention/treatment Phase
Plantar Fasciitis Procedure: Conservative physical therapy treatment with strengthening exercise program, and Conservative physical therapy treatment with stretching exercise program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Plantar Heel Pain: Multisegment Foot Motion and Muscle Function, FFI Translation, and Evaluation of Treatments-Subproject1 Investigation of Multisegmental Foot Motion and Muscle Activity in Patients With PHP Compared to the Normal Healthy Plantar Heel Pain: Effect of Physical Therapy With Strengthening Exercise and With Stretching Exercise in the Plantar Heel Pain Management: a Randomized Control Trial
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: (Sub-project 1)PHP / (Sub-project 3)Strengthening Procedure: Conservative physical therapy treatment with strengthening exercise program, and Conservative physical therapy treatment with stretching exercise program
(Sub-project 3) conservative physical therapy treatment with self-strengthening and with self-stretching home based exercises

Active Comparator: (Sub-project 1)Normal healthy / (Sub-project 3)Stretching
(Sub-project 3) Conservative physical therapy treatment with stretching exercise
Procedure: Conservative physical therapy treatment with strengthening exercise program, and Conservative physical therapy treatment with stretching exercise program
(Sub-project 3) conservative physical therapy treatment with self-strengthening and with self-stretching home based exercises




Primary Outcome Measures :
  1. Multisegmental foot motion (Sub-project 1) [ Time Frame: through study completion, an average of 1 year ]
    present with the degree of motion (degree)

  2. Multisegmental foot pattern (Sub-project 1) [ Time Frame: through study completion, an average of 1 year ]
    present with the minimal detectable change score (score)

  3. Muscle activity (Sub-project 1) [ Time Frame: through study completion, an average of 1 year ]
    present with percentage of maximum isometric voluntary contraction (%MVIC)

  4. Pain at worst score (Sub-project 3) [ Time Frame: through study completion, an average of 1 year ]
    present with visual analogue pain score (score)

  5. Foot function index score (Sub-project 3) [ Time Frame: through study completion, an average of 1 year ]
    present with a total score (score)


Secondary Outcome Measures :
  1. Lower extremity motion (Sub-project 1) [ Time Frame: through study completion, an average of 1 year ]
    present with the degree of motion (degree)

  2. Gait speed (Sub-project 1) [ Time Frame: through study completion, an average of 1 year ]
    present with meter per second (m/s)

  3. Step length (Sub-project 1) [ Time Frame: through study completion, an average of 1 year ]
    present with meter (m)

  4. Step time (Sub-project 1) [ Time Frame: through study completion, an average of 1 year ]
    present with second (s)

  5. Gait velocity (Sub-project 3) [ Time Frame: through study completion, an average of 1 year ]
    present with meter per second (m/s)

  6. Plantar fascia thickness (Sub-project 3) [ Time Frame: through study completion, an average of 1 year ]
    present with millimetre (mm)

  7. Lower extremity muscle strength (Sub-project 3) [ Time Frame: through study completion, an average of 1 year ]
    present with kilogram (kg)

  8. Ankle range of motion (Sub-project 3) [ Time Frame: through study completion, an average of 1 year ]
    present with degree of motion (degree)



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

(Sub-project 1) Inclusion criteria

Patients with PHP:

  • Age between 20 - 80 years
  • History of PHP for at least 1 month before enrollment
  • Pain or tenderness on palpation of the medial calcaneal tubercle or the proximal plantar fascia
  • Occurring at least one of the following complaints: pain on the first step in morning or after prolonged sitting, pain on prolonged standing, or pain when running
  • Thickness of the plantar fascia of 4.0 mm or greater assessing by US diagnosis

Healthy:

  • No past or present history of PHP or foot pain Exclusion criteria
  • Any coexisting painful musculoskeletal conditions of lower extremity; achilles or tibialis posterior tendinopathy, acute ankle sprain, tarsal tunnel syndrome, heel pad syndrome
  • Any fracture or surgery history in lower extremity and foot within 6 months
  • Lumbar radiculopathy or central or peripheral neuropathy
  • Systemic arthritis such as rheumatoid arthritis
  • Neurological or vascular compromise of the foot related to diabetes
  • Have a history of steroid injection within 6 months
  • Leg length discrepancy more than 1 centimeter
  • Currently taking pain medication

(Sub-project 3)

Inclusion criteria:

  • Age between 20 - 80 years
  • History of PHP for at least 1 month before enrollment
  • Pain or tenderness on palpation of the medial calcaneal tubercle or the proximal plantar fascia
  • Occurring at least one of the following complaints: pain on the first step in morning or after prolonged sitting, pain on prolonged standing, or pain when running
  • Thickness of the plantar fascia of 4.0 mm or greater assessing by US diagnosis

Exclusion criteria:

  • Any coexisting painful musculoskeletal conditions of lower extremity; achilles or tibialis posterior tendinopathy, acute ankle sprain, tarsal tunnel syndrome, heel pad syndrome
  • Any fracture or surgery history in lower extremity and foot within 6 months
  • Lumbar radiculopathy or central or peripheral neuropathy
  • Systemic arthritis such as rheumatoid arthritis
  • Neurological or vascular compromise of the foot related to diabetes
  • Have a history of steroid injection within 6 months
  • Leg length discrepancy more than 1 centimeter
  • Pregnancy
  • Administer other intervention programs or taking pain medication
  • Unable to perform the treatment exercise program

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): NCT03161314


Locations
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Thailand
Motion analysis laboratory
Salaya, Nakhonpathom, Thailand
Physical therapy center, Physical therapy faculty, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Thailand Research Fund
Investigators
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Principal Investigator: Sunee Bovonsunthonchai, PhD Mahidol University
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sunee Bovonsunthonchai, Principal Investigator, Mahidol University
ClinicalTrials.gov Identifier: NCT03161314    
Other Study ID Numbers: MU-CIRB 2016/182.0211
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Sunee Bovonsunthonchai, Mahidol University:
Plantar Fasciitis
Plantar Heel Pain
Multisegment Foot Motion
EMG
Gait
treatment
strengthening
stretching
exercise
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases