Clinical trial NCT04784598: Insoles Adapted in Flip-flop Sandals in People With Heel Pain
Official title: Effects of Insoles Adapted in Flip-flop Sandals in People With Heel Pain: a Randomized, Double-blind Clinical, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heel Pain Syndrome
Heel
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1- (n=40) The participant allocated to the insoles group adapted to flip-flops and classified as having a neutral foot according to the FPI-6 will receive a flip-flop with a horseshoe-type foot element on both feet to maintain symmetry between the limbs.

If the participant is classified with the foot pronated or supinated, only the painful foot will be modified since the symmetry of the limbs will not be modified. Participants with pronated foot will receive the medial wedge as a pedal element; already the participants with supinated foot, the lateral wedge. All elements will be 3mm and produced with EVA Shore 32.

• Group 2- The control group (n=40) will receive a slipper with a 2.5mm EVA cover (Shore A 32) identical to the one used by the intervention group, but without corrective par.
Primary purpose: TREATMENT

Brief summary: Introduction: Persistent hindfoot pains are very common and prevalent complaints in the Brazilian population. One of the treatments recommended for these conditions in the literature is the use of insoles. However, to use this resource it is necessary that the individual wear closed shoes and this is an obstacle to treatment in cities with hot climate. Thinking about an alternative treatment, the customized slippers with the corrective elements of the insoles can be an alternative to increase adherence to this type of treatment. Objective: To compare different types of hindfoot elements in insoles adapted in slippers in individuals with persistent hindfoot pain.

Detailed description: Methodology: This is a protocol for a controlled, randomized, blinded clinical trial. Eighty participants with persistent hindfoot pain will be evaluated and randomized into two intervention groups: insoles adapted to flip-flops and flip-flops with sham insole. The evaluations will be carried out at baseline (T0), after six (T6) and twelve weeks (T12) of the use of flip-flops, in addition to the follow-up that will be carried out four weeks after the end of the intervention (T16). The primary outcome will be pain, using the Numerical Pain Scale and the secondary outcomes will be: foot function, using the Foot Function Index questionnaire, functional capacity in walking, using the Six-Minute Walk Test and pain catastrophizing using the Scale. of Pain Catastrophizing. Statistical analysis: Data will be analyzed by T-student, Mann-Whitney and repeated measures ANOVA tests and will be analyzed by intention to treat. Ethics and disclosure: This protocol was approved by the Ethics Committee of UFRN/FACISA (number 4,018,821). The results of the study will be disseminated to participants and submitted to a peer-reviewed journal and scientific meetings.

Eligibility criteria: Inclusion Criteria:

* Individuals of both sexes, aged 18 to 65 years;
* Persistent heel pain for at least three months based on self-reported criteria: heel pain accompanying the first steps in the morning, after a period of inactivity, and/or during prolonged weight-bearing;
* Pain intensity between 3 and 8 points, according to the Numerical Rating Scale (NRS) \[22\];
* Individuals who can wear flip-flop sandals for at least four hours per day for 12 weeks.

Exclusion Criteria:

* Clinical diagnosis of neuropathic pain or neurodegenerative disorders, persistent heel pain due to rheumatic conditions, and previous ankle and foot surgeries;
* Physical therapy treatment in the last three months;
* Corticosteroid injection into feet in the last six months;
* inability to answer study-related questionnaires;
* Individuals scheduled to travel in the next six months.

Primary outcomes:
measure: Change in Numerical pain intensity scale - NPS
timeFrame: baseline, 6 weeks after, 12 weeks after, 16 weeks folow up
Secondary outcomes:
measure: Change in Foot function - FFI
timeFrame: baseline, 6 weeks after, 12 weeks after, 16 weeks folow up
measure: Change in Functional capacity - 6MWT
timeFrame: baseline and 12 weeks after
measure: Change in Pain Catastrophizing Scale (PCS)
timeFrame: baseline and 12 weeks after
measure: Expectation for treatment
timeFrame: baseline
measure: Satisfaction with treatment
timeFrame: 16 weeks after
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Marcelo Cardoso de Souza
state: RN
Study officials:
References:
citation: Costa ARA, de Almeida Silva HJ, Mendes AAMT, Scattone Silva R, de Almeida Lins CA, de Souza MC. Effects of insoles adapted in flip-flop sandals in people with plantar fasciopathy: a randomized, double-blind clinical, controlled study. Clin Rehabil. 2020 Mar;34(3):334-344. doi: 10.1177/0269215519893104. Epub 2019 Dec 6.
citation: Fagundes MG, Teixeira Mendes AAM, Barbosa GM, de Souza MC. Effects of insoles adapted in flip-flop sandals for persistent heel pain: a protocol for a sham-controlled randomised trial. BMJ Open. 2022 Nov 7;12(11):e062523. doi: 10.1136/bmjopen-2022-062523.