Plantar FasciitisPhase 2/3NCT01786057
Effect of Extracorporeal Shock Wave Therapy of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis
A Phase 2/3 study testing Extracorporeal shock wave therapy 1 and Extracorporeal shock wave therapy 2 in people with Plantar Fasciitis, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
Plantar fasciitis is one of the most common causes of heel pain. This study will be performed in the purpose of determination the effects of extracorporeal shock wave therapy of gastrosoleus trigger points in patients with plantar fasciitis Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Extracorporeal shock wave therapy 1 and Extracorporeal shock wave therapy 2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteIran
- Study dates
- Nov 2012to Oct 2013
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of plantar fasciitis
- having at least one Gastrosoleus trigger point concomitantly.
- having no response to conservative treatments for at least 3 months
- willingness to participate
Who cannot join
- Dysfunction of the knee or ankle
- Neurologic abnormalities
- Bleeding tendency (hereditary or acquired)
- Nerve entrapment syndrome
- A previous operation on the heel
- Pregnancy
Show all 9Show fewer
- Evidences of Infection in lower limbs
- A medical History of tumor
- previous local corticosteroid injection within 12 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Extracorporeal Shock Wave Therapy (ESWT)of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis
Plantar fasciitis is one of the most common causes of heel pain. This study will be performed in the purpose of determination the effects of extracorporeal shock wave therapy of gastrosoleus trigger points in patients with plantar fasciitis
Read the detailed description
Plantar fasciitis is the most common cause of inferior heel pain, A great variety of therapies have been reported for the treatment of plantar fasciitis including extracorporeal shock wave therapy. Gastrosoleus muscle dysfunction is one of the most common contributing factors to this disease .Despite the long history and the fact that this is a common diagnosis made in clinical practice, the exact cause and best treatment for this condition still are being explored. Although there is lack of high-quality studies demonstrating the efficacy of extracorporeal shock wave therapy of gastrosoleus trigger points in patients with plantar fasciitis , this study will be performed to examine the effect of extracorporeal shock wave therapy of gastrosoleus trigger points in patients with plantar fasciitis
- Conditions
- Plantar Fasciitis
- Being tested
- Extracorporeal shock wave therapy 1, Extracorporeal shock wave therapy 2
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapy 1Procedure or surgery
Extracorporeal shock wave therapy , (3000 shock waves/session of 0.2 mJ/mm2) for heel region and (400 shock waves/session of 0.2 mJ/mm2 per each trigger point) for gastrosoleus trigger points , 3 sessions at weekly intervals
Extracorporeal shock wave therapy 2Procedure or surgery
Extracorporeal shock wave therapy , (3000 shock waves/session of 0.2 mJ/mm2) for heel region , 3 sessions at weekly intervals
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal shock wave therapy 1 | Active comparator | Extracorporeal shock wave therapy , (3000 shock waves/session of 0.2 mJ/mm2) for heel region and (400 shock waves/session of 0.2 mJ/mm2 per each trigger point) for gastrosoleus trigger points , 3 sessions at weekly intervals Receives: Procedure: Extracorporeal shock wave therapy 1 |
| Extracorporeal shock wave therapy 2 | Placebo comparator | Extracorporeal shock wave therapy , (3000 shock waves/session of 0.2 mJ/mm2) for heel region , 3 sessions at weekly intervals Receives: Procedure: Extracorporeal shock wave therapy 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain severity after 3 weeks
The pain score (100 mm Visual Analogue Score ) is evaluated before the first session and 4 weeks after the last session.
Measured: Up to 4 weeks
Secondary outcomes (1)
Change from baseline in pain degree after 2 months.
The pain score (100 mm Visual Analogue Score ) and the modified criteria of the Roles and Maudsley score are evaluated at baseline and then 2 months after therapy.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionAug 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farnaz Dehgan Hosseinabadi, Isfahan University of Medical Sciences
- Investigators
- Farnaz Dehghan, MD, Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786057
- Sponsor's protocol ID
- 13914022
- Status last verified
- Feb 2013
- First submitted
- 1 Feb 2013
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang CJ, Wang FS, Yang KD, Weng LH, Ko JY. Long-term results of extracorporeal shockwave treatment for plantar fasciitis. Am J Sports Med. 2006 Apr;34(4):592-6. doi: 10.1177/0363546505281811.
PubMed 16556754Cotchett MP, Landorf KB, Munteanu SE, Raspovic A. Effectiveness of trigger point dry needling for plantar heel pain: study protocol for a randomised controlled trial. J Foot Ankle Res. 2011 Jan 23;4:5. doi: 10.1186/1757-1146-4-5.
PubMed 21255460Gleitz M, Hornig K. [Trigger points - Diagnosis and treatment concepts with special reference to extracorporeal shockwaves]. Orthopade. 2012 Feb;41(2):113-25. doi: 10.1007/s00132-011-1860-0. German.
PubMed 22349369Ogden JA, Alvarez RG, Marlow M. Shockwave therapy for chronic proximal plantar fasciitis: a meta-analysis. Foot Ankle Int. 2002 Apr;23(4):301-8. doi: 10.1177/107110070202300402.
PubMed 11991474
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Extracorporeal Shock Wave Therapy (ESWT)of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT01786057
- Acronym / sponsor ID
- 13914022
- Conditions
- Plantar Fasciitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 7 Feb 2013 (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.
Plantar fasciitis is one of the most common causes of heel pain. This study will be performed in the purpose of determination the effects of extracorporeal shock wave therapy of gastrosoleus trigger points in patients with plantar fasciitis
Detailed description
Plantar fasciitis is the most common cause of inferior heel pain, A great variety of therapies have been reported for the treatment of plantar fasciitis including extracorporeal shock wave therapy. Gastrosoleus muscle dysfunction is one of the most common contributing factors to this disease .Despite the long history and the fact that this is a common diagnosis made in clinical practice, the exact cause and best treatment for this condition still are being explored. Although there is lack of high-quality studies demonstrating the efficacy of extracorporeal shock wave therapy of gastrosoleus trigger points in patients with plantar fasciitis , this study will be performed to examine the effect of extracorporeal shock wave therapy of gastrosoleus trigger points in patients with plantar fasciitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal shock wave therapy 1 | Active comparator | Procedure: Extracorporeal shock wave therapy 1Extracorporeal shock wave therapy , (3000 shock waves/session of 0.2 mJ/mm2) for heel region and (400 shock waves/session of 0.2 mJ/mm2 per each trigger point) for gastrosoleus trigger points , 3 sessions at weekly intervals |
| Extracorporeal shock wave therapy 2 | Placebo comparator | Procedure: Extracorporeal shock wave therapy 2Extracorporeal shock wave therapy , (3000 shock waves/session of 0.2 mJ/mm2) for heel region , 3 sessions at weekly intervals |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis of plantar fasciitis
- having at least one Gastrosoleus trigger point concomitantly.
- having no response to conservative treatments for at least 3 months
- willingness to participate
Key exclusion criteria (9 listed)
- Dysfunction of the knee or ankle
- Neurologic abnormalities
- Bleeding tendency (hereditary or acquired)
- Nerve entrapment syndrome
- A previous operation on the heel
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 |
|---|---|---|
| Extracorporeal shock wave therapy 1Extracorporeal shock wave therapy , (3000 shock waves/session of 0.2 mJ/mm2) for heel region and (400 shock waves/session of 0.2 mJ/mm2 per each trigger point) for gastrosoleus trigger points , 3 sessions at weekly intervals | Procedure or surgery | Extracorporeal shock wave therapy 1 |
| Extracorporeal shock wave therapy 2Extracorporeal shock wave therapy , (3000 shock waves/session of 0.2 mJ/mm2) for heel region , 3 sessions at weekly intervals | Procedure or surgery | Extracorporeal shock wave therapy 2 |
Primary outcome
Change from baseline in pain severity after 3 weeks
Time frame: Up to 4 weeks
The pain score (100 mm Visual Analogue Score ) is evaluated before the first session and 4 weeks after the last session.
1 secondary outcome
Change from baseline in pain degree after 2 months.
Time frame: Up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
- Results publication: PubMed 16556754Wang CJ, Wang FS, Yang KD, Weng LH, Ko JY. Long-term results of extracorporeal shockwave treatment for plantar fasciitis. Am J Sports Med. 2006 Apr;34(4):592-6. doi: 10.1177/0363546505281811.
- Results publication: PubMed 21255460Cotchett MP, Landorf KB, Munteanu SE, Raspovic A. Effectiveness of trigger point dry needling for plantar heel pain: study protocol for a randomised controlled trial. J Foot Ankle Res. 2011 Jan 23;4:5. doi: 10.1186/1757-1146-4-5.
- Results publication: PubMed 22349369Gleitz M, Hornig K. [Trigger points - Diagnosis and treatment concepts with special reference to extracorporeal shockwaves]. Orthopade. 2012 Feb;41(2):113-25. doi: 10.1007/s00132-011-1860-0. German.
- Results publication: PubMed 11991474Ogden JA, Alvarez RG, Marlow M. Shockwave therapy for chronic proximal plantar fasciitis: a meta-analysis. Foot Ankle Int. 2002 Apr;23(4):301-8. doi: 10.1177/107110070202300402.
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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.
Farnaz Dehghan, MD principal investigator
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Extracorporeal shock wave therapy 1 and Extracorporeal shock wave therapy 2 in people with Plantar Fasciitis, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Feb 2013. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change from baseline in pain severity after 3 weeks (time frame: Up to 4 weeks). 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 NCT01786057, which also lists 4 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 7 Feb 2013.