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Comparison of the Effectiveness of USG and Palpation Guidance Steroid Injection in Patients With Plantar Fasciitis

Comparison of the Effectiveness of USG and Palpation Guidance Steroid Injection in Patients With Plantar Fasciitis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04709484
Enrollment
66
Registered
2021-01-14
Start date
2021-03-11
Completion date
2021-08-01
Last updated
2021-10-20

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

Conditions

Plantar Fasciitis

Keywords

Plantar Fasciitis, USG, Steroid, Injection

Brief summary

Plantar fasciitis, often described as overloading of the plantar fascia, is the most common cause of heel pain in adults. It is characterized by a sharp pain along the medial aspect of the heel, which is worse with the first step taken in the morning or at the beginning of an activity and decreases as the person warms up. The etiology of plantar fasciitis is multifactorial and not well understood. Poor biomechanics and changes in the structure of the foot can lead to repeated micro-trauma at the beginning of the plantar fascia, causing inflammation and degeneration. Plantar fasciitis is more common in sedentary individuals and athletes and those participating in running sports. Other risk factors associated with plantar fasciitis include reduced ankle dorsiflexion, increased body mass index (BMI), and work-related weight loss activities. Current treatments for plantar fasciitis, such as plantar fascia stretching exercises, strapping, extracorporeal shock wave therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), arch braces, and heel pads are mainly aimed at reducing inflammation. Corticosteroid injections are usually reserved for refractory plantar fasciitis after conservative noninvasive attempts have failed. It has been shown to effectively reduce heel pain in patients with plantar fasciitis. The strong anti-inflammatory effect of corticosteroids can speed up the process of pain relief. In our study, we aimed to compare the effectiveness of USG and palpation guidance blind steroid injection in patients diagnosed with plantar fasciitis.

Detailed description

It is planned to enroll 60 (sixty) patients in the study. Patients diagnosed with plantar fasciitis, between the ages of 18-75, who have failed conservative treatment (stretching exercises, non-steroidal anti-inflammatory drugs and heel pads) for at least 3 months, and those with a Visual Anolog Scale value of 5 and above will be included in the study. Any local injection therapy and physical therapy for heel pain in the last 4 months, any surgery history for heel pain, history of tarsal tunnel syndrome, ankle effusion showing intra-articular disease, healed calcaneal fracture, Achilles tendinopathy, foot including pes and any deformity of the ankle, planus or pes cavus deformity; Patients with systemic disorders such as diabetes mellitus, rheumatoid arthritis, hematological disease or gout, pregnancy, history of aspirin or aspirin-like medication, and mental insufficiency will be excluded from the study. In the study, the patients will be filled in Visual Analogue Scale (VAS) and Foot Function Indez (FFI) questionnaires. Patients will be randomized into 2 groups according to the Random Number Generation. The first group will be the USG-guided steroid injection group, and the second group will be the palpation-guided steroid injection group. In the USG-guided group, steroid injection will be made to the area where the fascia is thickened under the guidance of USG. In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone. There will be pre-injection, 1st month and 3rd month controls after injection.

Interventions

DRUGUSG-guided steroid injection

In the palpation-guided group, the most painful point will be found by palpation on the calcaneus boIn the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.ne and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.

DRUGPalpation-guided steroid injection

In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.

Sponsors

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

double(participant, outcomes assesor double)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Patients diagnosed with plantar fasciitis 2. Between the ages of 18-75 3. Who have failed conservative treatment (stretching exercises, non-steroidal anti-inflammatory drugs and heel pads) for at least 3 months 4. Visual Anolog Scale value of 5 and above will be included in the study.

Exclusion criteria

1. Having received any local injection therapy and physical therapy for heel pain within the last 4 months, 2. Any history of surgery for heel pain, tarsal tunnel syndrome, calcaneal fracture, Achilles tendinopathy, any deformity of the foot and ankle including pes, planus or pes cavus deformity 3. with systemic disorders such as diabetes mellitus, rheumatoid arthritis, hematological disease, or gout 4. Pregnancy 5. A recent history of aspirin or aspirin-like medication 6. mental disability

Design outcomes

Primary

MeasureTime frameDescription
Pain Severityday 0 (before intervention)visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain. Higher values represent a worse outcome.

Secondary

MeasureTime frameDescription
Foot Function Indexday 0 (before intervention)Foot Function Index(FFI) is a self-report questionnaire concerning foot function and pain. The FFI consists of 23 questions with scores 0-10 in three domains concerning foot pain, function and disability resulting in a total score range from 0 to 230. The score is validated for patients with plantar fasciitis with a minimal clinical important difference being 7 points. Higher values represent a worse outcome.

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

ArmCount
USG-guided Steroid Injection Group
In the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone. USG-guided steroid injection: In the palpation-guided group, the most painful point will be found by palpation on the calcaneus boIn the USG-guided group, steroid injection will be made to the area where the fascia is thickened under USG guidance. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.ne and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.
34
Palpation-guided Steroid Injection Group
In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone. Palpation-guided steroid injection: In the palpation-guided group, the most painful point will be found by palpation on the calcaneus bone and steroid injection will be made to that part. The content of the steroid solution will be 1 ml of 1% Lidocaine + 1 ml (40 mg) methylprednisolone.
32
Total66

Baseline characteristics

CharacteristicTotalUSG-guided Steroid Injection GroupPalpation-guided Steroid Injection Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants3 Participants1 Participants
Age, Categorical
Between 18 and 65 years
62 Participants31 Participants31 Participants
Age, Continuous47.92 years
STANDARD_DEVIATION 9
47.12 years
STANDARD_DEVIATION 8.29
48.78 years
STANDARD_DEVIATION 9.76
Body Mass Index29.82 kg/m^2
STANDARD_DEVIATION 4.61
29.92 kg/m^2
STANDARD_DEVIATION 4.47
29.71 kg/m^2
STANDARD_DEVIATION 4.81
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
66 Participants34 Participants32 Participants
Region of Enrollment
Turkey
66 participants34 participants32 participants
Sex: Female, Male
Female
58 Participants29 Participants29 Participants
Sex: Female, Male
Male
8 Participants5 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Pain Severity

visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain. Higher values represent a worse outcome.

Time frame: day 0 (before intervention)

Population: intent to treat population(all participants)

ArmMeasureValue (MEAN)Dispersion
USG-guided Steroid Injection GroupPain Severity8.50 score on a scaleStandard Deviation 0.9
Palpation-guided Steroid Injection GroupPain Severity8.31 score on a scaleStandard Deviation 0.9
Primary

Pain Severity

visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain. Higher values represent a worse outcome.

Time frame: 1 month after intervention

Population: intent to treat population(all participants)

ArmMeasureValue (MEAN)Dispersion
USG-guided Steroid Injection GroupPain Severity1.50 score on a scaleStandard Deviation 1.83
Palpation-guided Steroid Injection GroupPain Severity1.53 score on a scaleStandard Deviation 2.29
Primary

Pain Severity

visual analog scale (0-10) minimum score: 0 maximum score: 10. Higher scores reflect more severe pain. Higher values represent a worse outcome.

Time frame: 3 month after intervention

Population: intent to treat population(all participants)

ArmMeasureValue (MEAN)Dispersion
USG-guided Steroid Injection GroupPain Severity1.44 score on a scaleStandard Deviation 2.08
Palpation-guided Steroid Injection GroupPain Severity1.75 score on a scaleStandard Deviation 2.46
Secondary

Foot Function Index

Foot Function Index(FFI) is a self-report questionnaire concerning foot function and pain. The FFI consists of 23 questions with scores 0-10 in three domains concerning foot pain, function and disability resulting in a total score range from 0 to 230. The score is validated for patients with plantar fasciitis with a minimal clinical important difference being 7 points. Higher values represent a worse outcome.

Time frame: day 0 (before intervention)

Population: intent to treat population(all participants)

ArmMeasureValue (MEAN)Dispersion
USG-guided Steroid Injection GroupFoot Function Index65.41 score on a scaleStandard Deviation 12.78
Palpation-guided Steroid Injection GroupFoot Function Index63.78 score on a scaleStandard Deviation 13.8
Secondary

Foot Function Index

Foot Function Index(FFI) is a self-report questionnaire concerning foot function and pain. The FFI consists of 23 questions with scores 0-10 in three domains concerning foot pain, function and disability resulting in a total score range from 0 to 230. The score is validated for patients with plantar fasciitis with a minimal clinical important difference being 7 points. Higher values represent a worse outcome.

Time frame: 1 month after intervention

Population: intent to treat population(all participants)

ArmMeasureValue (MEAN)Dispersion
USG-guided Steroid Injection GroupFoot Function Index8.06 score on a scaleStandard Deviation 13.46
Palpation-guided Steroid Injection GroupFoot Function Index7.47 score on a scaleStandard Deviation 13.66
Secondary

Foot Function Index

Foot Function Index(FFI) is a self-report questionnaire concerning foot function and pain. The FFI consists of 23 questions with scores 0-10 in three domains concerning foot pain, function and disability resulting in a total score range from 0 to 230. The score is validated for patients with plantar fasciitis with a minimal clinical important difference being 7 points. Higher values represent a worse outcome.

Time frame: 3 month after intervention

Population: intent to treat population(all participants)

ArmMeasureValue (MEAN)Dispersion
USG-guided Steroid Injection GroupFoot Function Index9.32 score on a scaleStandard Deviation 14.15
Palpation-guided Steroid Injection GroupFoot Function Index8.41 score on a scaleStandard Deviation 14.53

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026