Skip to content

Effect of different Insoles in patients with Plantar Fasciitis

Effect of different Insoles hardness in patients with Plantar Fasciitis: Randomized control trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9dbpb8n
Enrollment
Unknown
Registered
2023-02-13
Start date
2021-09-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plantar Fasciítis

Interventions

The study is blind and the intervention will be carried out with the use of insoles. Participants will undergo a Screening zero (T0) screening and evaluation. After that, they will be divided into 3 g
Group 1: Insoles 21 Shore A, Group 2: Insoles 35 Shore A, Group 3: Insoles 50 Shore A. After 8 weeks of intervention they will be reassessed in person, and in the 12th and 16th week follow up by phone
kinesiophobia, catastrophization, and self-perception in patients with plantar fasciitis.

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: Participants must be between 30 and 65 years old, both sexes. Participants must present pain for at least twelve weeks and grading at least 3 on the numerical pain scale, in the following situations: in the first steps of the morning and on palpation at the insertion of the plantar fascia located in the medial tubercle of the calcaneus. In addition to at least one of the following criteria: pain after a period of inactivity; pain in the plantar fascia after a recent increase in activities beyond the usual; or Positive Windlass Test.

Exclusion criteria

Exclusion criteria: volunteers who have: Fibromyalgia; musculoskeletal and neuromuscular disorder of a systemic nature; have used custom insoles; have undergone physiotherapy sessions; and have presented musculoskeletal injuries in the lower limbs in the last six months.

Design outcomes

Primary

MeasureTime frame
Will be considered the primary outcome pain intensity in the 8th week after randomization, evaluated by the 11-point numerical pain scale. A change of 1 point, on this scale, between the initial assessment and the 8th week after randomization will be considered a clinically significant change.

Secondary

MeasureTime frame
The following will be evaluated as secondary outcomes: function (assessed by the Foot Functions Index) at 8, 12, and 16 weeks after randomization. It will be verified if the phenomenon occurred by identifying at least 5% variation in the measurements at the 8th, 12th, and 16th weeks after randomization.;The following will be evaluated as secondary outcomes:comfort (assessed by the Likert scale); at 8, 12, and 16 weeks after randomization. It will be verified if the phenomenon occurred by identifying at least 5% variation in the measurements at the 8th, 12th, and 16th weeks after randomization. ;The following will be evaluated as secondary outcomes: catastrophizing (assessed by The Pain Catastrophizing Scale) at 8, 12, and 16 weeks after randomization. It will be verified if the phenomenon occurred by identifying at least 5% variation in the measurements at the 8th, 12th, and 16th weeks after randomization.;The following will be evaluated as secondary outcomes: kinesiophobia (assessed by the Tampa Scale for Kinesiophobia) at 8, 12, and 16 weeks after randomization. It will be verified if the phenomenon occurred by identifying at least 5% variation in the measurements at the 8th, 12th, and 16th weeks after randomization.

Countries

Brazil

Contacts

Public ContactVanderlei Brito Junior

Universidade Federal de São Paulo

vanderlei.brito@unifesp.br+55 19 32333007

Outcome results

None listed

Source: REBEC (via WHO ICTRP)