Plantar FascitisNCT03731897
Evaluation of the Efficacy of Prolotherapy Treatment in Patients With Plantar Fasciitis: a Randomized Double-blind Study
A study testing 5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine. and 9 cc salin + 1cc 2% lidocaine. in people with Plantar Fascitis, run by Ankara Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Plantar fasciitis is the most common cause of heel pain and it is diagnosed by clinically. Resting, stretching exercises, weight loss, nonsteroidal anti-inflammatory drugs and physical therapy methods are used in the treatment. Steroid injection can be applied in patients who do not respond to these treatments. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- 5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine. and 9 cc salin + 1cc 2% lidocaine.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2018to 12 Jun 2019
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-65 year-old.
- Heel pain for at least 3 months
- Plantar fasciitis which diagnosed clinically and confirmed using ultrasonography (plantar fascia thickness > 4mm)
Who cannot join
- History of chronic pain syndromes
- Patients undergoing steroid injections for the treatment of plantar fasciitis in the last 6 months
- Rheumatic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: to Evaluate the Efficacy of Prolotherapy Treatment and Compare the Control Group in Patients With Plantar Fasciitis: a Randomized Double-blind Study
Plantar fasciitis is the most common cause of heel pain and it is diagnosed by clinically.
Resting, stretching exercises, weight loss, nonsteroidal anti-inflammatory drugs and physical therapy methods are used in the treatment. Steroid injection can be applied in patients who do not respond to these treatments. But steroid injection is not a pathology-based treatment, and also can cause serious side effects, such as fat pad atrophy and plantar fascia rupture. At this stage, in patients who do not respond to conservative treatments, new methods such as dextrose prolotherapy and platelet rich plasma may be used instead of steroid injection. In the literature, there is insufficient study showing effect of prolotherapy in patients with plantar fasciitis. Because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trial to assess the effect after prolotherapy injection in patients with plantar fasciitis.
The participants evaluated with clinically and sonographically. The aim of this study is to compare the pain, function and thickness of proximal plantar fascia in prolotherapy or control group.
Read the detailed description
After obtaining written informed consent, patients of clinically and sonographically diagnosed with plantar fasciitis were randomized into intervention and control group. Participants in intervention group received two-session prolotherapy injection and control group received two-session 9cc salin + 1 cc 2% lidocaine injection in 3 weeks interval. Stretching and range of motion exercises were prescribed after treatment.
The primary outcome is visual analog scale (VAS) and secondary outcomes include Foot Function Index , ultrasonographic measurement of proximal plantar fascia. The evaluation was performed pretreatment as well as on the 1st and 3th month the treatment.
- Conditions
- Plantar Fascitis
- Being tested
- 5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine., 9 cc salin + 1cc 2% lidocaine.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine.Other
Plantar fascia will be injected to the places where it adheres to the bone.
9 cc salin + 1cc 2% lidocaine.Other
Plantar fascia will be injected to the places where it adheres to the bone.
| Study group | Role | What they receive |
|---|---|---|
| prolotherapy | Experimental | Experimental: Plantar fasciitis injection with prolotherapy total 5cc. Procedure: Plantar fascia will be injected to the places where it adheres to the bone.
Drug: 5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine. This treatment, known as regenerative injection therapy, stimulates tissue repair and reduces pain. Receives: Other: 5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine. |
| control | Placebo comparator | Placebo Comparator: Plantar fasciitis injection with 9cc salin + 1 cc 2% lidocaine total 5cc.
Procedure: Plantar fascia will be injected to the places where it adheres to the bone.
Drug: 9 cc salin + 1cc 2% lidocaine. This treatment is safe for Plantar fasciitis injection. Receives: Other: 9 cc salin + 1cc 2% lidocaine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of pain on 1st and 3th months after treatment: VAS
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. Recorded on a visual analogue scale (VAS), scores range from 0 to 100 mm, with higher scores indicating worse pain.
Measured: Pre-treatment, 1st and 3th months after treatment
Secondary outcomes (2)
Change from baseline in activity and functional status on 1st and 3th months after treatment.
Using the Foot Function Index (FFI) to measure the activity and functional status before treatment and multiple time frame after treatment. . The FFI consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation. The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week. The higher scores indicate worse pain. Both total and subcategory scores are calculated.
Measured: Pre-treatment, 1st and 3th months after treatment
Change from baseline in thickness of proximal plantar fascia on 1st and 3th months after treatment.
Using the musculoskeletal sonogram to measure the proximal plantar fascia thickness.
Measured: Pre-treatment, 1st and 3th months after treatment treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start12 Nov 2018
- Primary completion12 Mar 2019
- Study completion12 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Basak Mansiz-Kaplan, Ankara Education and Research Hospital
- Investigators
- Basak Mansiz-Kaplan, Principal investigator, Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731897
- Sponsor's protocol ID
- E171615
- Status last verified
- Jul 2019
- First submitted
- 4 Nov 2018
- Last updated
- 18 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- to Evaluate the Efficacy of Prolotherapy Treatment and Compare the Control Group in Patients With Plantar Fasciitis: a Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT03731897
- Acronym / sponsor ID
- E171615
- Conditions
- Plantar Fascitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Education and Research HospitalOther government
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 12 Mar 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 6 Nov 2018 (actual)
- 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 the most common cause of heel pain and it is diagnosed by clinically.
Resting, stretching exercises, weight loss, nonsteroidal anti-inflammatory drugs and physical therapy methods are used in the treatment. Steroid injection can be applied in patients who do not respond to these treatments. But steroid injection is not a pathology-based treatment, and also can cause serious side effects, such as fat pad atrophy and plantar fascia rupture. At this stage, in patients who do not respond to conservative treatments, new methods such as dextrose prolotherapy and platelet rich plasma may be used instead of steroid injection. In the literature, there is insufficient study showing effect of prolotherapy in patients with plantar fasciitis. Because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trial to assess the effect after prolotherapy injection in patients with plantar fasciitis.
The participants evaluated with clinically and sonographically. The aim of this study is to compare the pain, function and thickness of proximal plantar fascia in prolotherapy or control group.
Detailed description
After obtaining written informed consent, patients of clinically and sonographically diagnosed with plantar fasciitis were randomized into intervention and control group. Participants in intervention group received two-session prolotherapy injection and control group received two-session 9cc salin + 1 cc 2% lidocaine injection in 3 weeks interval. Stretching and range of motion exercises were prescribed after treatment.
The primary outcome is visual analog scale (VAS) and secondary outcomes include Foot Function Index , ultrasonographic measurement of proximal plantar fascia. The evaluation was performed pretreatment as well as on the 1st and 3th month the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prolotherapy | Experimental | Other: 5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine.Experimental: Plantar fasciitis injection with prolotherapy total 5cc. Procedure: Plantar fascia will be injected to the places where it adheres to the bone. Drug: 5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine. This treatment, known as regenerative injection therapy, stimulates tissue repair and reduces pain. |
| control | Placebo comparator | Other: 9 cc salin + 1cc 2% lidocaine.Placebo Comparator: Plantar fasciitis injection with 9cc salin + 1 cc 2% lidocaine total 5cc. Procedure: Plantar fascia will be injected to the places where it adheres to the bone. Drug: 9 cc salin + 1cc 2% lidocaine. This treatment is safe for Plantar fasciitis injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18-65 year-old.
- Heel pain for at least 3 months
- Plantar fasciitis which diagnosed clinically and confirmed using ultrasonography (plantar fascia thickness > 4mm)
Key exclusion criteria (3 listed)
- History of chronic pain syndromes
- Patients undergoing steroid injections for the treatment of plantar fasciitis in the last 6 months
- Rheumatic diseases
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 |
|---|---|---|
| 5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine.Plantar fascia will be injected to the places where it adheres to the bone. | Other | prolotherapy |
| 9 cc salin + 1cc 2% lidocaine.Plantar fascia will be injected to the places where it adheres to the bone. | Other | control |
Primary outcome
Change from baseline of pain on 1st and 3th months after treatment: VAS
Time frame: Pre-treatment, 1st and 3th months after treatment
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. Recorded on a visual analogue scale (VAS), scores range from 0 to 100 mm, with higher scores indicating worse pain.
2 secondary outcomes
Change from baseline in activity and functional status on 1st and 3th months after treatment.
Time frame: Pre-treatment, 1st and 3th months after treatment
Change from baseline in thickness of proximal plantar fascia on 1st and 3th months after treatment.
Time frame: Pre-treatment, 1st and 3th months after treatment treatment
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 18 Jun 2020.
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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.
Basak Mansiz-Kaplan principal investigator
Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine. and 9 cc salin + 1cc 2% lidocaine. in people with Plantar Fascitis, run by Ankara Education and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 18 Jun 2020. 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 Turkey (Türkiye). 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.
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?
Change from baseline of pain on 1st and 3th months after treatment: VAS (time frame: Pre-treatment, 1st and 3th months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2020.