Plantar FasciitisPhase 4NCT02448316
Plantar Fasciitis, Operation or Conservative Treatment
A Phase 4 study testing endoscopic surgery, methylprednisolon and lidokaine in people with Plantar Fasciitis, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to compare in a randomized controlled trial the effect of endoscopic operation with the standard conservative treatmentprotocol with training supplemented with 1-3 injections of glucocorticoids in patients with chronic plantar fasciopathia. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- endoscopic surgery, methylprednisolon and lidokaine
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2015to 1 Nov 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pain at the medial attachment of fascia plantaris
- first step pain in the morning
- symptoms for at least 3 months
- ultrasound scanning at the first visit shows thickness of the proximal fascia above 4 mm
- patient can read and understand danish
Who cannot join
- known arthritis inflammatory bowl disease, psoriasis or clinical signs of any of these.
- leg ulcerations
- long lasting oedema of the leg and foot
- palpatory decreased puls in the foot
- diabetes
- reduced sensibility in the foot
Show all 12Show fewer
- infections in the foot
- daily use of pain killers
- pregnancy or planning to become pregnant
- earlier operations on the foot, that is judged to complicate training.
- patients assessed not to be able to participate in the training for other reasons
- Glucocorticosteroid injection to the diseased plantar fascia within the last 6 months
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
Copenhagen, 2400
About this study
Official title: Randomized Clinical Trial Comparing Conventional Conservative Treatment for Plantar Fasciopathia With Endoscopic Surgery With Fascial Release.
The purpose of this study is to compare in a randomized controlled trial the effect of endoscopic operation with the standard conservative treatmentprotocol with training supplemented with 1-3 injections of glucocorticoids in patients with chronic plantar fasciopathia.
Read the detailed description
Plantars fasciitis (PF) is a frequently diagnosed condition, defined as pain at the medial tubercle of the calcaneus, and 10% of the population will at some points in their life experience this condition. Accumulated loading of the plantar fascia seems to relate to development of PF, as it is commonly seen in runners and those who are overweight, and number of daily steps or simply time of standing has been shown to be a predisposing factor for PF development ( Orthosis and glucocorticoid injections are 2 widely used treatments and in most clinics the standard treatment, despite the fact that a recent Cochrane review found limited evidence for treatment of plantar heelpain.
Once the condition gets chronic the response to several kinds of treatment is less predictable. However it has been demonstrated that endoscopic surgery for plantar fasciitis using a deep-fascial approach was successful in individuals with an active sports anamnesis, and all patients returned with this treatment to full athletic activities within 8-15 weeks. This high succesrate is not seen in conservative treatment with decrease in activity, training and injections of glucocorticosteroid, eventhough they had shorter disease duration. Therefore the investigators think it would be interesting to offer this minimal invasive operation to patients much earlier in the disease, especially as there is no reported severe sideeffects .
However, surgery is very seldom compared with results of other treatment modalities, and no randomized studies exist on the effect of operation vs the normal conservative standard-treatment.
The purpose of this study is to compare in a randomized controlled trial the effect of endoscopic operation with the standard conservative treatmentprotocol with training supplemented with 1-3 injections of glucocorticoids in patients with chronic plantar fasciopathia.
- Conditions
- Plantar Fasciitis
- Being tested
- endoscopic surgery, methylprednisolon, lidokaine, Training
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic surgeryProcedure or surgery
Also called Fascial release, Heel spur resection, Training
Through 2 portals profound for the fascia plantaris (deep-fascial) lateral and medial a heel-spur will be resected and the medial half of the fascia is released from its attachment to the calcaneus.
A mikroskopic X-ray sensitive pearle (Tantalum-pearle) will be inserted in the fascia in the proximal end of the distal part of the remaining fascia for measuring distance (resorbtion).
Three weeks after operation, the patients are instructed to start a specific training program. Training is supervised every third week by a physiotherapist (week 3,6,9,12 after operation), and daily training is carried out at home. Sutures are removed after 10 days,
methylprednisolonDrug
Also called Depo-medrol, Glucocorticosteroid injection
1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible
lidokaineDrug
Also called Xylocain
1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible
TrainingBehavioural
Also called strength training, stretching
the patient is instructed in reduction in impact. strength training 3 times weekly and stretching exercises daily are recommended.
| Study group | Role | What they receive |
|---|---|---|
| endoscopic surgery | Active comparator | Endoscopic operation through 2 portals profound for the fascia plantaris Receives: Procedure: endoscopic surgery |
| conservative treatment | Active comparator | The standard treatment here acting as controle treatment . All patients are informed to decrease activity level, use shoes with good shock absorption and are recommended to use insoles (standard orthoses) for increased shock absorption. Training is supervised every third week by a physiotherapist (week 1,3,6,9), and daily training is carried out at home. Glucocorticoid injections of 1 ml Glucocorticosteroid (methylprednisolon 40 mg) and 1 ml of Lidokaine 5mg/ml from the medial side profound to the thickened part of the fascia plantaris are given every month until the fascia thickness is below 4 mm (max 3 injections). Receives: Drug: methylprednisolon; Drug: lidokaine; Behavioral: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Function Index
Foot Function Index (FFI) is a validated score usefull for plantar fasciitis. It consists of 23 questions concerning pain, function and impact on daily life. Each question is answered on a box scale 0-10, giving a score range: 0-230
Measured: 6 months
Foot Function Index
Foot Function Index (FFI) is a validated score usefull for plantar fasciitis. It consists of 23 questions concerning pain, function and impact on daily life. Each question is answered on a box scale 0-10, giving a score range: 0-230
Measured: 12 months
Secondary outcomes (12)
100 mm VAS score for morning pain
Measured: 3 months
100 mm VAS score for morning pain
Measured: 6 months
100 mm VAS score for morning pain
Measured: 12 months
100 mm VAS score for morning pain
Measured: 24 months
100 mm VAS score for pain at function
Measured: 3 months
100 mm VAS score for pain at function
Measured: 6 months
100 mm VAS score for pain at function
Measured: 12 months
100 mm VAS score for pain at function
Measured: 24 months
single leg jumping length
Standing on the diseased leg, the patient jumps as far as possible landing on the same leg. the best of 3 trials.
Measured: 12 months
positionel MR scanning (pMRI)
only for the operated patients the change in bone position in standing is measured using a pMRI, where bone position is measured in supine and standing before and 12 months after the operation. This will also include patients referred directly to operation and therefore not included in the RCT
Measured: 12 months
Tantalum pearle-calcaneus distance
only for operated patients the distance from calcaneus to a Tantalum pearle inserted in the plantar fascia during operation is measured by lying and standing X-ray. This will also include patients referred directly to operation and therefore not included in the RCT
Measured: 12 months
Foot Function Index
Foot Function Index (FFI) is a validated score usefull for plantar fasciitis. It consists of 23 questions concerning pain, function and impact on daily life. Each question is answered on a box scale 0-10, giving a score range: 0-230
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study start1 Apr 2015
- Primary completion1 Nov 2016
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Rheumatism Association
- Responsible party
- Principal investigator, Finn Elkjær Johannsen, Bispebjerg Hospital
- Investigators
- Finn MD Johannsen, MD, Principal investigator, Institute of Sports Medicine Copenhagen, Bispebjerg Hospital Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448316
- Sponsor's protocol ID
- H-2-2012-151
- Status last verified
- Mar 2017
- First submitted
- 10 May 2015
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Baldassin V, Gomes CR, Beraldo PS. Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for noncomplicated plantar fasciitis: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Apr;90(4):701-6. doi: 10.1016/j.apmr.2008.11.002.
PubMed 19345789Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.
PubMed 12917892Neufeld SK, Cerrato R. Plantar fasciitis: evaluation and treatment. J Am Acad Orthop Surg. 2008 Jun;16(6):338-46. doi: 10.5435/00124635-200806000-00006.
PubMed 18524985Tsai WC, Hsu CC, Chen CP, Chen MJ, Yu TY, Chen YJ. Plantar fasciitis treated with local steroid injection: comparison between sonographic and palpation guidance. J Clin Ultrasound. 2006 Jan;34(1):12-6. doi: 10.1002/jcu.20177.
PubMed 16353228Uden H, Boesch E, Kumar S. Plantar fasciitis - to jab or to support? A systematic review of the current best evidence. J Multidiscip Healthc. 2011;4:155-64. doi: 10.2147/JMDH.S20053. Epub 2011 May 24.
PubMed 21655342Komatsu F, Takao M, Innami K, Miyamoto W, Matsushita T. Endoscopic surgery for plantar fasciitis: application of a deep-fascial approach. Arthroscopy. 2011 Aug;27(8):1105-9. doi: 10.1016/j.arthro.2011.02.037. Epub 2011 Jun 24.
PubMed 21704466Bazaz R, Ferkel RD. Results of endoscopic plantar fascia release. Foot Ankle Int. 2007 May;28(5):549-56. doi: 10.3113/FAI.2007.0549.
PubMed 17559761Jerosch J, Schunck J, Liebsch D, Filler T. Indication, surgical technique and results of endoscopic fascial release in plantar fasciitis (E FRPF). Knee Surg Sports Traumatol Arthrosc. 2004 Sep;12(5):471-7. doi: 10.1007/s00167-004-0496-6. Epub 2004 Apr 14.
PubMed 15088083Kalaci A, Cakici H, Hapa O, Yanat AN, Dogramaci Y, Sevinc TT. Treatment of plantar fasciitis using four different local injection modalities: a randomized prospective clinical trial. J Am Podiatr Med Assoc. 2009 Mar-Apr;99(2):108-13. doi: 10.7547/0980108.
PubMed 19299346
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Conventional Conservative Treatment for Plantar Fasciopathia With Endoscopic Surgery With Fascial Release.
- ClinicalTrials.gov ID
- NCT02448316
- Acronym / sponsor ID
- H-2-2012-151
- Conditions
- Plantar Fasciitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- The Danish Rheumatism Association
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare in a randomized controlled trial the effect of endoscopic operation with the standard conservative treatmentprotocol with training supplemented with 1-3 injections of glucocorticoids in patients with chronic plantar fasciopathia.
Detailed description
Plantars fasciitis (PF) is a frequently diagnosed condition, defined as pain at the medial tubercle of the calcaneus, and 10% of the population will at some points in their life experience this condition. Accumulated loading of the plantar fascia seems to relate to development of PF, as it is commonly seen in runners and those who are overweight, and number of daily steps or simply time of standing has been shown to be a predisposing factor for PF development ( Orthosis and glucocorticoid injections are 2 widely used treatments and in most clinics the standard treatment, despite the fact that a recent Cochrane review found limited evidence for treatment of plantar heelpain.
Once the condition gets chronic the response to several kinds of treatment is less predictable. However it has been demonstrated that endoscopic surgery for plantar fasciitis using a deep-fascial approach was successful in individuals with an active sports anamnesis, and all patients returned with this treatment to full athletic activities within 8-15 weeks. This high succesrate is not seen in conservative treatment with decrease in activity, training and injections of glucocorticosteroid, eventhough they had shorter disease duration. Therefore the investigators think it would be interesting to offer this minimal invasive operation to patients much earlier in the disease, especially as there is no reported severe sideeffects .
However, surgery is very seldom compared with results of other treatment modalities, and no randomized studies exist on the effect of operation vs the normal conservative standard-treatment.
The purpose of this study is to compare in a randomized controlled trial the effect of endoscopic operation with the standard conservative treatmentprotocol with training supplemented with 1-3 injections of glucocorticoids in patients with chronic plantar fasciopathia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoscopic surgery | Active comparator | Procedure: endoscopic surgeryEndoscopic operation through 2 portals profound for the fascia plantaris |
| conservative treatment | Active comparator | Drug: methylprednisolon, Drug: lidokaine, Behavioral: TrainingThe standard treatment here acting as controle treatment . All patients are informed to decrease activity level, use shoes with good shock absorption and are recommended to use insoles (standard orthoses) for increased shock absorption. Training is supervised every third week by a physiotherapist (week 1,3,6,9), and daily training is carried out at home. Glucocorticoid injections of 1 ml Glucocorticosteroid (methylprednisolon 40 mg) and 1 ml of Lidokaine 5mg/ml from the medial side profound to the thickened part of the fascia plantaris are given every month until the fascia thickness is below 4 mm (max 3 injections). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pain at the medial attachment of fascia plantaris
- first step pain in the morning
- symptoms for at least 3 months
- ultrasound scanning at the first visit shows thickness of the proximal fascia above 4 mm
- patient can read and understand danish
Key exclusion criteria (12 listed)
- known arthritis inflammatory bowl disease, psoriasis or clinical signs of any of these.
- leg ulcerations
- long lasting oedema of the leg and foot
- palpatory decreased puls in the foot
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic surgeryAlso: Fascial release, Heel spur resection, TrainingThrough 2 portals profound for the fascia plantaris (deep-fascial) lateral and medial a heel-spur will be resected and the medial half of the fascia is released from its attachment to the calcaneus. A mikroskopic X-ray sensitive pearle (Tantalum-pearle) will be inserted in the fascia in the proximal end of the distal part of the remaining fascia for measuring distance (resorbtion). Three weeks after operation, the patients are instructed to start a specific training program. Training is supervised every third week by a physiotherapist (week 3,6,9,12 after operation), and daily training is carried out at home. Sutures are removed after 10 days, | Procedure or surgery | endoscopic surgery |
| methylprednisolonAlso: Depo-medrol, Glucocorticosteroid injection1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible | Drug | conservative treatment |
| lidokaineAlso: Xylocain1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible | Drug | conservative treatment |
| TrainingAlso: strength training, stretchingthe patient is instructed in reduction in impact. strength training 3 times weekly and stretching exercises daily are recommended. | Behavioural | conservative treatment |
Primary outcome
Foot Function Index
Time frame: 6 months
Foot Function Index (FFI) is a validated score usefull for plantar fasciitis. It consists of 23 questions concerning pain, function and impact on daily life. Each question is answered on a box scale 0-10, giving a score range: 0-230
Foot Function Index
Time frame: 12 months
Foot Function Index (FFI) is a validated score usefull for plantar fasciitis. It consists of 23 questions concerning pain, function and impact on daily life. Each question is answered on a box scale 0-10, giving a score range: 0-230
12 secondary outcomes
100 mm VAS score for morning pain
Time frame: 3 months
100 mm VAS score for morning pain
Time frame: 6 months
100 mm VAS score for morning pain
Time frame: 12 months
100 mm VAS score for morning pain
Time frame: 24 months
100 mm VAS score for pain at function
Time frame: 3 months
100 mm VAS score for pain at function
Time frame: 6 months
100 mm VAS score for pain at function
Time frame: 12 months
100 mm VAS score for pain at function
Time frame: 24 months
single leg jumping length
Time frame: 12 months
positionel MR scanning (pMRI)
Time frame: 12 months
Tantalum pearle-calcaneus distance
Time frame: 12 months
Foot Function Index
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Background: PubMed 19345789Baldassin V, Gomes CR, Beraldo PS. Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for noncomplicated plantar fasciitis: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Apr;90(4):701-6. doi: 10.1016/j.apmr.2008.11.002.
- Background: PubMed 12917892Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.
- Background: PubMed 18524985Neufeld SK, Cerrato R. Plantar fasciitis: evaluation and treatment. J Am Acad Orthop Surg. 2008 Jun;16(6):338-46. doi: 10.5435/00124635-200806000-00006.
- Background: PubMed 16353228Tsai WC, Hsu CC, Chen CP, Chen MJ, Yu TY, Chen YJ. Plantar fasciitis treated with local steroid injection: comparison between sonographic and palpation guidance. J Clin Ultrasound. 2006 Jan;34(1):12-6. doi: 10.1002/jcu.20177.
- Background: PubMed 21655342Uden H, Boesch E, Kumar S. Plantar fasciitis - to jab or to support? A systematic review of the current best evidence. J Multidiscip Healthc. 2011;4:155-64. doi: 10.2147/JMDH.S20053. Epub 2011 May 24.
- Background: PubMed 21704466Komatsu F, Takao M, Innami K, Miyamoto W, Matsushita T. Endoscopic surgery for plantar fasciitis: application of a deep-fascial approach. Arthroscopy. 2011 Aug;27(8):1105-9. doi: 10.1016/j.arthro.2011.02.037. Epub 2011 Jun 24.
- Background: PubMed 17559761Bazaz R, Ferkel RD. Results of endoscopic plantar fascia release. Foot Ankle Int. 2007 May;28(5):549-56. doi: 10.3113/FAI.2007.0549.
- Background: PubMed 15088083Jerosch J, Schunck J, Liebsch D, Filler T. Indication, surgical technique and results of endoscopic fascial release in plantar fasciitis (E FRPF). Knee Surg Sports Traumatol Arthrosc. 2004 Sep;12(5):471-7. doi: 10.1007/s00167-004-0496-6. Epub 2004 Apr 14.
- Background: PubMed 19299346Kalaci A, Cakici H, Hapa O, Yanat AN, Dogramaci Y, Sevinc TT. Treatment of plantar fasciitis using four different local injection modalities: a randomized prospective clinical trial. J Am Podiatr Med Assoc. 2009 Mar-Apr;99(2):108-13. doi: 10.7547/0980108.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Finn MD Johannsen, MD principal investigator
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing endoscopic surgery, methylprednisolon and lidokaine in people with Plantar Fasciitis, run by Bispebjerg Hospital at 1 site in Denmark.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 11 Jul 2018. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot Function Index (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02448316, which also lists 9 linked publications.
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 11 Jul 2018.