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Plantar FascitisPLATOXNCT05218785

Treatment of Gastrocnemius Tightness and Subsequent Chronic Plantar Fasciitis with Botulinum Toxin a

An observational study of Plantar Fascitis and Gastrocnemius Tightness, run by Oslo University Hospital at 1 site in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective clinical cohort study will follow 40 patients who recieve botulinum toxin A treatment for proximal medial gastrocnemius tightness with subsequent Chronic Plantar Fasciitis for two years. Three injections of botulinum toxin (75IU) will be administered with intervals of three months. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Plantar Fascitis, Gastrocnemius Tightness
What is being tested?
Botox
Type of treatment
Injection or infusion
How many people
40 participants
Where
1 siteNorway
Study dates
13 Jan 2022to Jan 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The population consists of patients who recieve routine care at our hospital.

Who may be able to join

  • Age 18-75 years.
  • An isolated gastrocnemius contracture must be verified with the Silfverskiölds test before inclusion.
  • Diagnosis plantar fasciitis verified clinically by an orthopaedic surgeon.
  • Diagnosis verified by MRI. MRI criteria: Thickening of the plantar fascia, oedema in the calcaneus, pathological signal changes in the plantar fascia (35)
  • Duration of symptoms must be at least 12 months prior to first BTA injection.
  • Conventional Physical Therapy must have been tried at least three months without a significant reduction of symptoms in the affected foot.

Who cannot join

  • Previously undergone surgery for plantar fasciitis.
  • Patients with severe talocrural pathology or serious malalignment of foot and ankle
  • Severely reduced peripheral circulation
  • History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.
  • Patients with a contraindication/non-compliance for MRI examination.
  • History of allergic reaction/anaphylactic reaction or other contraindication to botulinum toxin.
  • Not able to read and/or speak a Scandinavian language or English adequately.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elisabet Ellingsen Husebye, MD PhD contact

+47 91 50 27 70

uxngng@ous-hf.no

Martin Riiser, MD Phd candidate contact

+47 91 50 27 70

mriise@ous-hf.no

Norway1 site, 1 recruiting

  • Oslo University Hospital, Orthopedic Department Ullevål

    Oslo, Oslo

    Elisabeth Ellingsen Husebye, MD PhD, 91 50 27 70, uxngng@ous-hf.no

    Martin Riiser, MD, +47 91 50 27 70, mriise@ous-hf.no

    Recruiting

Other trials in Norway

About this study

Official title: Botulinum Toxin Injection As Treatment for Proximal Medial Gastrocnemius Muscle Tightness with Subsequent Chronic Plantar Fasciitis - a Prospective Clinical Cohort Study

This prospective clinical cohort study will follow 40 patients who recieve botulinum toxin A treatment for proximal medial gastrocnemius tightness with subsequent Chronic Plantar Fasciitis for two years. Three injections of botulinum toxin (75IU) will be administered with intervals of three months. Participants will be followed at baseline, 3 months, 6 months, 1 year and 2 years with Patient Related Outcome Measures (PROMS) and physical test (Ergotest and ankle dorsiflexion).

Read the detailed description

The connection between gastrocnemius tightness and plantar fasciitis has been demonstrated in several clinical studies. Patients with chronic pathology, and unsatisfactory results from physical therapy, may benefit from gastrocnemius lengthening. This is usually obtained with proximal medial gastrocnemius recession surgery (PMGR), but recent studies and recent experience from our hospital suggest that similar effect may be obtained with ultrasound guided- injections of Botulinum Toxin A injections in the proximal medial gastrocnemius muscle.

This study will follow patients with gastrcnemius tightness (demonstrated by the Silferskiolds test) and subsequent chronic (MRI-verified) plantar fasciitits who has not recieved satisfactiory results from at least three months of guided physcial therapy.

Participants will recieve three ultrasound guided injections of 75IU of Botulinum Toxin A with three month intervals.

They will be followed with clinical controls for two years after the first injection.

THe main outcome is the Manchester Oxford Foot Questionnaire (MOxFQ).

Being tested
Botox
Keywords
proximal medial gastrocnemius recession, gastrocnemius tightness, botox, botulinum toxin a

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BotoxDrug

    75 U in medial gastrocbemius head. x 3

Study groups in NCT05218785
Study groupRoleWhat they receive
Botulinum toxin A injectionPatients will receive a total of 3 -three - injections of 75 IU Botulinum Toxin A in the proximal medial gastrocnemius muscle. Treatments will be performed by a specialist in neurology as a Ultra-Sound guided injection into the proximal medial gastrocnemius muscle Injections will be administered at baseline, 3 months and 6 months.
Receives: Drug: Botox

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Manchester Oxford Foot Questionnaire

    MOxFQ (Manchester Oxford Foot Questionnaire) is a PROM consisting of 16 questions in three domains (pain, walking/standing, social interaction) leading to a total score from 0-100, 0 being the best possible score. It is validated as a reliable tool to measure results of foot and ankle surgery

    Measured: 2 years

Secondary outcomes (6)

  1. Achilles function test battery

    The test battery consists of three jump tests, a counter movements jump (CMJ), a drop counter movement jump (drop CMJ) and hopping, and two strength tests, concentric toe-raises (resistance 13+23 kg), eccentric-concentric toe-raises (resistance 13+23 kg) and toe-raises for endurance. All recorded through the MuscleLab software.

    Measured: 2 years

  2. Ankle dorsiflexion

    measured by device that measures the ankle's range of motion that has been previously tested and found to be valid, reliable, and responsive in detecting isolated gastrocnemius contractures (IGCs). (40) An electric goniometer, Biometrics SG150 (Units 25-26, Biometrics Ltd, Newport, UK), with an accuracy of ±2 degrees and a repeatability of 1 degree will be used. The device will be calibrated before every new participant. Force applied directly beneath the head of the second metatarsal until the end range of dorsiflexion with a dynamometer.

    Measured: 2 years

  3. Visual Analogue Scale (VAS)

    Visual Analogue Scale for pain during use om affected leg in the last 24 hours. 0 is no pain. 10 is worst pain imaginable

    Measured: 2 years

  4. EQ5D5L

    Quality of life is measured by the EuroQol questionnaire (EQ-5D). EQ-5D is a validated generic health-related quality-of-life instrument. It consists of two parts: EQ-5D descriptive part and EQ-5D visual analogue scale. The descriptive part includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with three possible answers ("no problems", "some problems", and "major problems"). EQ5D VAS is a visual analogue scale of self-related overall health, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)

    Measured: 2 years

  5. AOFAS (American Orthopeadic Foot and Ancle Society) hindfoot score

    AOFAS score measures pain, function, movement and deformity. It ranges from 0-100, 100 being the best possible score. The score is in our opinion not especially fit to measure the symptoms and change in symptoms in plantar fasciitis patients, but we include it to be able to compare our results to Abassain et al.

    Measured: 2 years

  6. Adverse events

    . I.e. infection, nerve injury, thrombosis.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study start13 Jan 2022
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05218785
Sponsor's protocol ID
REK351430
Acronym
PLATOX
Status last verified
Mar 2025
First submitted
20 Jan 2022
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Plantar Fascitis and Gastrocnemius Tightness, run by Oslo University Hospital at 1 site in Norway.

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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Mar 2025. 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 Norway. 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elisabet Ellingsen Husebye, MD PhD (+47 91 50 27 70, uxngng@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Manchester Oxford Foot Questionnaire (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05218785.

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 30 Mar 2025.

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