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Effectiveness of Postural Insoles Adapted in Slippers for People With Persistent Heel Pain

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: NCT03482518
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Marcelo Cardoso de Souza, Universidade Federal do Rio Grande do Norte

Brief Summary:
Introduction: Persistent heel pain from plantar fasciitis and calcaneal spurs, as well as metatarsalgia, are very common and prevalent complaints in the Brazilian population. One of the recommended treatments for these conditions in the literature is the use of insoles. However, the use of this feature requires the individual to wear closed shoes and this is an obstacle to treatment in cities with hot weather. Thinking about an alternative treatment, the customized slippers with the corrective elements of the insoles can be an alternative to increase the adhesion to this type of treatment. Objective: To evaluate the effectiveness of the insoles adapted in slippers in the improvement of the pain and the function in individuals with persistent pains in the backfoot of the city of Santa Cruz, RN. Methodology: This is a double-blind, randomized, controlled clinical study in which 66 patients diagnosed with persistent back pain and metatarsalgias will be divided into two groups. The intervention group will receive a customized slipper with foot pieces and synthetic leather cover, and the control group will receive a slipper without customization, only with a synthetic leather cover as used by the intervention group. The evaluator and the patient will be considered blind. Evaluations will be performed at baseline (T0), after 12 weeks of wearing the slippers (T12) and a reassessment at week 16 (T16) for pain monitoring. The evaluation instruments used will be the EVA (visual pain scale) and the algometer in the painful region of the foot; FFI - Foot Function Index questionnaire and FAAM questionnaire - Foot and Ankle Ability Measure for functional evaluation, and finally the 6 - minute walking test for walking performance. Statistical analysis: Data will be analyzed by t-test, Mann-Whitney test, repeated-measures ANOVA and intention-to-treat analysis.

Condition or disease Intervention/treatment Phase
Heel Pain Syndrome Metatarsalgia Other: custom slippers with perforated synthetic leather cover. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized controlled trial
Masking: Double (Participant, Investigator)
Masking Description: Participants will be informed that they will be drawn to participate in one of the two groups (intervention group or control group). Allocation in the groups will be done randomly, by lot, following the order of randomization, keeping the confidentiality, ie, one should not know to which group the participant will be sent before he / she agrees to be evaluated and sign the TCLE.
Primary Purpose: Treatment
Official Title: Effectiveness of Postural Insoles Adapted in Slippers for People With Persistent Heel Pain and Metatarsalgias: a Clinical, Controlled, Randomized and Double Blind Study
Actual Study Start Date : April 17, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 7, 2019

Arm Intervention/treatment
Experimental: Intervention Group
The intervention group volunteers will receive a pair of custom slippers with perforated synthetic leather cover with elements in insoles. They will be advised to wear the slipper for 4 hours in the first week and up to 8 hours after that period. Should any part of you feel uncomfortable, the participant should return immediately so that the appropriate adjustments are made in the slipper
Other: custom slippers with perforated synthetic leather cover.
the intervention group volunteers will receive a pair of custom slippers with perforated synthetic leather cover.

Sham Comparator: Control group

The control (sham) group volunteers will receive a pair of custom slippers with perforated synthetic leather cover as those used by GI.

The difference will be that these slippers will not have the elements in the insoles.

Other: custom slippers with perforated synthetic leather cover.
the intervention group volunteers will receive a pair of custom slippers with perforated synthetic leather cover.




Primary Outcome Measures :
  1. Change in VAS - Visual Analog Scale [ Time Frame: in baseline and 12 week ]
    Visual Analog Scale - 0 - 10. Likert scale, 0 - no pain and 10 - worst pain


Secondary Outcome Measures :
  1. Change in FFI - Foot Function Index questionnaire [ Time Frame: baseline and 12 week ]
    Foot Function Index questionnaire - To obtain the total score for each domain, the following formula was applied: sum of the score obtained from all items answered by the patient / possible total score of the domain × 100 in order to obtain the percentage value. If the patient does not do any activity indicated by one of the items (for example, do not make use of auxiliary devices), this is considered as not applicable. Thus, the scoring of these items will not be considered in the total sum of the domain. The final percentage of all domains must be summed and divided by three (total number of domains) to obtain the final result of the questionnaire. Results may range from 0 to 100% and are directly proportional to limb functional impairment. The higher the percentage, the greater is the functional alteration presented by the patient

  2. Change in FAAM - Foot and Ankle Ability Measure [ Time Frame: baseline and 12 week ]
    The scores for each of the items are added together to obtain the item score total. The total number of items with a response is then multiplied by 4 to obtain the highest potential score. If all 21 items were answered, the highest potential score would be 84. If one item was unanswered the highest potential score would be 80, if two items were unanswered the total highest score would be 76, and so forth. The total item score is divided by the highest potential score and then multiplied by 100 to produce the FAAM score, which ranges from 0 to 100. The Sports subscale is scored in a similar manner; the highest potential score is 32. As with the ADL subscale, the item score total is divided by the highest potential score and multiplied by 100. A higher score represents a higher level of physical function for both the ADL and Sports subscales.

  3. Change in 6MWT - 6-minute walk test [ Time Frame: baseline and 12 week ]
    1. The course can vary from 20 to 50 meters away, depending on the size of the aisle.
    2. Marking a line transverse to the demarcated space for the displacement at the beginning of the test.
    3. If test repeats are required, for comparison or evaluation of the outcome, subsequent tests should be performed at the same time as the 1st test day.

    (d) If a test is to be performed at least 10 minutes blood pressure, heart rate, and O 2 saturation. e) At the end of the test, the evaluator must be informed that he / she should walk slowly across the direction of the test to measure the distance by the evaluator, which should also demonstrate the scale of perceived effort and question the intensity of the test. test.




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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of both sexes with a diagnosis of persistent back pain and / or pain in the head region of the metatarsals for more than 3 months, aged 18-60 years, accustomed to wearing slippers that are not performing other types of physical therapy and sign the ICF.

Exclusion Criteria:

  • Patients with foot wounds, previous foot and ankle surgeries, rheumatic diseases and / or skin diseases and those reporting that they can not wear slippers.

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): NCT03482518


Locations
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Brazil
Marcelo Souza
Santa Cruz, Rio Grande Do Norte, Brazil, 59200-000
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
Investigators
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Principal Investigator: Marcelo Cardoso de Souza, PT,PhD Universidade Federal do Rio Grande do Norte

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Responsible Party: Marcelo Cardoso de Souza, Assistant professor, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT03482518    
Other Study ID Numbers: UFRNCHINELOS
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: there is not a plan to make individual participant data (IPD) available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metatarsalgia
Foot Diseases
Musculoskeletal Diseases
Joint Diseases
Pain
Neurologic Manifestations
Signs and Symptoms