Heel Pain SyndromeNCT03482518
Effectiveness of Postural Insoles Adapted in Slippers for People With Persistent Heel Pain
A study testing custom slippers with perforated synthetic leather cover. in people with Heel Pain Syndrome and Metatarsalgia, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Heel Pain Syndrome, Metatarsalgia
- What is being tested?
- custom slippers with perforated synthetic leather cover.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Apr 2018to 7 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with foot wounds, previous foot and ankle surgeries, rheumatic diseases and / or skin diseases and those reporting that they can not wear slippers.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
The evaluations for the prescription of the insoles will be made at the Physiotherapy School Clinic of FACISA / UFRN and a podoscope will be used to evaluate the foot typology and other morphological aspects, a pen to print the feet and make a mold for making the insoles. insoles, and different prosthetic parts molded previously.
The volunteers will be invited to participate in the research and, upon accepting, will be informed of the research procedures, sign the informed consent form and only then will be evaluated by the blind evaluator of the study. It will also be informed that it can be drawn for any of the two groups (intervention group or control group). Allocation in groups will be done randomly, by lot.
All volunteers, regardless of groups, will be evaluated individually, in a comfortable room, barefoot and wearing shorts or shorts.
Evaluations will occur at the baseline (T0), after 12 weeks of use of the slippers (T12) and at the follow up 4 weeks after the end of the intervention (T16).
The following evaluation tools will be used:
- Pain by Visual Analog Scale and algometer;
- The function of the foot by the FFI (Foot Function Index) questionnaire;
- Foot and ankle functionality by FAAM (Foot and Ankle Ability Measure);
- Functional ability by the 6-minute walk test;
- After this step, the volunteers will be evaluated on the podoscope using the foot pieces for the postural evaluation (fig 3). In the protocol, the volunteer's posture will be evaluated using the foot pieces to verify their influence on static balance and postural asymmetries. The volunteers will be evaluated in the frontal and sagittal planes.
- Finally, the volunteers will carry out the plantations (fig 4) that will be sent to make the slippers.
6.2 Calculation of the sample The investigators will select 66 patients from the list of patients at the Physiotherapy School Clinic of the FACISA / UFRN, with diagnosis of calcaneal spurs, fasciitis and / or metatarsalgia, according to clinical evaluation criteria. The project will also be broadcast by local radio and media.
The sample size was calculated based on the EVA variable, considering a power of 90%, a significance of 5% and a loss rate of 10%. Based on the study by Chuter, Searle and Spink (2016), where with similar methods they found a difference of 1.3 points, considering the standard deviation of this variable being equal to 1.8. Based on these data, a sample of 66 subjects with 33 in each group was necessary to detect a clinically important difference. The calculation was based on comparisons of two samples by Gpower 3.1 software. The randomization will be through a computer program, and from this result, the chips will be placed in opaque and sealed envelopes to maintain allocation secrecy.
6.3 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.
6.4 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.
6.5 Interventions Intervention Group (GI) - the intervention group volunteers will receive a pair of custom slippers with perforated synthetic leather cover. 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 disturb you, the participant should return immediately to the appropriate adjustments to be made in the slipper.
Control group (CG) - control group volunteers will receive custom slippers with the same coverage as those used by GI. The difference will be that these slippers will not have the elements podais, will be a slipper with smooth surface.
- Conditions
- Heel Pain Syndrome, Metatarsalgia
- Being tested
- custom slippers with perforated synthetic leather cover.
- Medical subject headings
- Metatarsalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
custom slippers with perforated synthetic leather cover.Other
the intervention group volunteers will receive a pair of custom slippers with perforated synthetic leather cover.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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 Receives: Other: custom slippers with perforated synthetic leather cover. |
| Control group | Sham comparator | 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. Receives: Other: custom slippers with perforated synthetic leather cover. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VAS - Visual Analog Scale
Visual Analog Scale - 0 - 10. Likert scale, 0 - no pain and 10 - worst pain
Measured: in baseline and 12 week
Secondary outcomes (3)
Change in FFI - Foot Function Index questionnaire
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
Measured: baseline and 12 week
Change in FAAM - Foot and Ankle Ability Measure
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.
Measured: baseline and 12 week
Change in 6MWT - 6-minute walk test
- The course can vary from 20 to 50 meters away, depending on the size of the aisle.
- Marking a line transverse to the demarcated space for the displacement at the beginning of the test.
- 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.
Measured: baseline and 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start17 Apr 2018
- Primary completion1 Jan 2019
- Study completion7 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heel Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Cardoso de Souza, Universidade Federal do Rio Grande do Norte
- Investigators
- Marcelo Cardoso de Souza, PT,PhD, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482518
- Sponsor's protocol ID
- UFRNCHINELOS
- Status last verified
- Jan 2019
- First submitted
- 15 Mar 2018
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is not a plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03482518
- Acronym / sponsor ID
- UFRNCHINELOS
- Conditions
- Heel Pain Syndrome, Metatarsalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The evaluations for the prescription of the insoles will be made at the Physiotherapy School Clinic of FACISA / UFRN and a podoscope will be used to evaluate the foot typology and other morphological aspects, a pen to print the feet and make a mold for making the insoles. insoles, and different prosthetic parts molded previously.
The volunteers will be invited to participate in the research and, upon accepting, will be informed of the research procedures, sign the informed consent form and only then will be evaluated by the blind evaluator of the study. It will also be informed that it can be drawn for any of the two groups (intervention group or control group). Allocation in groups will be done randomly, by lot.
All volunteers, regardless of groups, will be evaluated individually, in a comfortable room, barefoot and wearing shorts or shorts.
Evaluations will occur at the baseline (T0), after 12 weeks of use of the slippers (T12) and at the follow up 4 weeks after the end of the intervention (T16).
The following evaluation tools will be used:
- Pain by Visual Analog Scale and algometer;
- The function of the foot by the FFI (Foot Function Index) questionnaire;
- Foot and ankle functionality by FAAM (Foot and Ankle Ability Measure);
- Functional ability by the 6-minute walk test;
- After this step, the volunteers will be evaluated on the podoscope using the foot pieces for the postural evaluation (fig 3). In the protocol, the volunteer's posture will be evaluated using the foot pieces to verify their influence on static balance and postural asymmetries. The volunteers will be evaluated in the frontal and sagittal planes.
- Finally, the volunteers will carry out the plantations (fig 4) that will be sent to make the slippers.
6.2 Calculation of the sample The investigators will select 66 patients from the list of patients at the Physiotherapy School Clinic of the FACISA / UFRN, with diagnosis of calcaneal spurs, fasciitis and / or metatarsalgia, according to clinical evaluation criteria. The project will also be broadcast by local radio and media.
The sample size was calculated based on the EVA variable, considering a power of 90%, a significance of 5% and a loss rate of 10%. Based on the study by Chuter, Searle and Spink (2016), where with similar methods they found a difference of 1.3 points, considering the standard deviation of this variable being equal to 1.8. Based on these data, a sample of 66 subjects with 33 in each group was necessary to detect a clinically important difference. The calculation was based on comparisons of two samples by Gpower 3.1 software. The randomization will be through a computer program, and from this result, the chips will be placed in opaque and sealed envelopes to maintain allocation secrecy.
6.3 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.
6.4 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.
6.5 Interventions Intervention Group (GI) - the intervention group volunteers will receive a pair of custom slippers with perforated synthetic leather cover. 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 disturb you, the participant should return immediately to the appropriate adjustments to be made in the slipper.
Control group (CG) - control group volunteers will receive custom slippers with the same coverage as those used by GI. The difference will be that these slippers will not have the elements podais, will be a slipper with smooth surface.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: custom slippers with perforated synthetic leather cover.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 |
| Control group | Sham comparator | Other: custom slippers with perforated synthetic leather cover.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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with foot wounds, previous foot and ankle surgeries, rheumatic diseases and / or skin diseases and those reporting that they can not wear slippers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| custom slippers with perforated synthetic leather cover.the intervention group volunteers will receive a pair of custom slippers with perforated synthetic leather cover. | Other | Control group, Intervention Group |
Primary outcome
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
3 secondary outcomes
Change in FFI - Foot Function Index questionnaire
Time frame: baseline and 12 week
Change in FAAM - Foot and Ankle Ability Measure
Time frame: baseline and 12 week
Change in 6MWT - 6-minute walk test
Time frame: baseline and 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Individual participant dataSharing planned: No. there is not a plan to make individual participant data (IPD) available to other researchers.
Related trials for Heel Pain Syndrome
Not yet recruiting
Acupuncture for Heel Pain Syndrome
Heel Pain Syndrome
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Individualized Rehabilitation for Osgood-Schlatter or Sever Pain in Youth Athletes
Osgood-Schlatter Disease, Sever's Disease
Not yet recruiting
Baxter's Nerve Pulsed Radiofrequency Versus Platelet-Rich Plasma Injection or Both Together as a Treatment Modality of Recalcitrant Plantar Fasciitis
Plantar Fasciitis, Heel Pain
Not yet recruiting
Effect of Kaltenborn vs Mulligan Mobilization With Intrinsic Foot Strengthening in Plantar Fasciitis
Plantar Fascitis, Heel Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo Cardoso de Souza, PT,PhD principal investigator
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing custom slippers with perforated synthetic leather cover. in people with Heel Pain Syndrome and Metatarsalgia, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VAS - Visual Analog Scale (time frame: in baseline and 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.