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

NCT03482518 | Completed DMC

• 1 other identifier: UFRNCHINELOS
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Heel Pain Syndrome; Metatarsalgia

Outcome Measures

Primary Outcomes (1)

• Change in VAS - Visual Analog Scale

  Visual Analog Scale - 0 - 10. Likert scale, 0 - no pain and 10 - worst pain

  in baseline and 12 week

Secondary Outcomes (3)

• Change in FFI - Foot Function Index questionnaire

  baseline and 12 week

• Change in FAAM - Foot and Ankle Ability Measure

  baseline and 12 week

• Change in 6MWT - 6-minute walk test

  baseline and 12 week

Study Arms (2)

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

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.

Other: custom slippers with perforated synthetic leather cover.

Interventions

custom slippers with perforated synthetic leather cover. OTHER

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

Control group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Marcelo Souza

Santa Cruz, Rio Grande do Norte, 59200-000, Brazil

Location

MeSH Terms

Conditions

Metatarsalgia

Condition Hierarchy (Ancestors)

Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcelo Cardoso de Souza, PT,PhD

  Universidade Federal do Rio Grande do Norte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: A randomized controlled trial

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 29, 2018
• Study Start: April 17, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 7, 2019
• Last Updated: January 8, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)