Plantar Calcaneal SpurNCT01439932
Effectiveness of Manual Therapy Combined With Standard Treatment in the Management of Plantar Fasciitis
A study testing algometer in people with Plantar Calcaneal Spur and Fasciitis, Plantar, run by Meir Medical Center at 1 site in Israel.
Trial summary
Background: Plantar fasciitis (PF) is a common problem that tends to attack about 10% of the population during life. This is a degenerative condition of the plantar fascia at its insertion at the bottom of the heel. Pain appears mainly on the first steps in the morning or after prolonged lack of weight bearing. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plantar Calcaneal Spur, Fasciitis, Plantar
- What is being tested?
- algometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2011to Feb 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75
- Pain allocated at the bottom of heel and produced by pressure
- Pain in the morning at first steps or after prolonged non-weight bearing
- NPRS morning pain score of 3 or higher
Who cannot join
- Tumors
- Prolonged use of steroids
- Fracture below knee during the last year
- Prior foot surgeries
- A positive diagnosis of Tarsal Tunnel Syndrome (TTS) / Fat Pad Syndrome
- Pregnancy
- Lack of availability in the coming month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Manual Therapy Combined With Standard Treatment in the Management of Plantar Fasciitis, a Randomized Control Trial
Background: Plantar fasciitis (PF) is a common problem that tends to attack about 10% of the population during life. This is a degenerative condition of the plantar fascia at its insertion at the bottom of the heel. Pain appears mainly on the first steps in the morning or after prolonged lack of weight bearing. The pain intensity can be very high and this can cause functional limitations and reduce quality of life.
Despite the high prevalence of the PF, treatment is controversial and not supported by extensive research. Review of the previous studies on various treatments, mentioned steroid injections, shock waves, night splint, orthotics, heel padding and stretching exercises.
Read more
Limitation of ankle dorsi flexion is a common finding and thought to be a contributing factor to the development of pathology. So far, this issue had been addressed mainly by soft tissue therapy techniques to improve ankle range of motion in patients with PF. Only one study (Joshua et al 2009) evaluated the effect of ankle joint mobilizations of PF. However, in this study mobilizations were part of complex therapy and therefore the effect of treatment cannot be attributed solely to them.
The purpose of this study is to evaluate the effectiveness of ankle and mid-foot joints mobilization on pain and function of patients with PF.
The hypothesis is that manual mobilizations of ankle and midfoot joints in addition to conventional physical therapy will improve pain and function significantly more than conventional treatment, in patients with PF.
Methods: 50 patients, age 18-75 with a diagnosis of PF that meet the inclusion criteria will be recruited and randomly divided into two groups. Both groups will receive commonly accepted physical therapy treatment that includes stretching exercise of the plantar fascia and triceps surae muscles and ultrasound therapy at the site of symptoms. The study group will receive in addition manual mobilizations to the ankle and midfoot joints. The procedures will take place at the physiotherapy clinic Bat-Yamon of General Health Services and will last four weeks, twice a week.
Read the detailed description
A prospective randomized double-blinded controlled clinical trial. Setting: Bat-Yamon physical therapy clinic of Clalit health services in Bat Yam.
Ethical considerations: The research proposal will be submitted for the approval of the Helsinki Committee at Meir Hospital in Kefar Saba. All patients will sign informed consent form according to the laws of medical ethics.
Subjects will be recruited from all the population of patients who are referred to physical therapy for the treatment of PF with diagnosis of plantar fasciitis or calcaneal spur.
Randomization will be carried out using envelopes that will be prepared in advance. Each patient will receive at the end of the baseline examination envelope with the type of treatment for which will be delivered only to the therapist so that the examiner and the patient will be blind to the treatment group.
Baseline and final evaluations will be performed by the examiner-therapist and treatments performed by three physical therapists at the Bat-Yamon clinic with experience of at least 3 years which will receive proper instruction and training.
Baseline examination will be performed after completing informed consent form and will include demographic information to be filled by patient, clinical interview and examination by the examiner. Demographic information includes age, gender, weight, BMI (calculated by the examiner), history of the problem, habits related to physical activity and occupation and general health.
The interview will refer to etiology and nature of symptoms. The clinical examination will include observation of foot structure and gait pattern, the presence of hit or swelling. Palpation for pain location and for ruling out fat pad Syndrome, clunk test and neurodynamic of tibial nerve will be performed to rule out tarsal tunnel syndrome (TTS). Patients with suspicion for one of these diagnoses will not be recruited. Dorsi flexion range of motion in both legs will be measured and compared to the range at the end of treatment. Measurement will be taken in two ways, once weight bearing with inclinometer - the patient stands in lounge position while tested leg in front and asked to bend the knee of this leg as possible without lifting the heel off the floor. The angle measured is the angle between the tibia and a vertical line to the floor.Second time without weight bearing with Goniometer- the patient lies on his back with a pillow under the tested knee , the therapist performs maximum dorsi flexion passively and asks the patient to add an active movement in the same direction. The angle measured is between fibula and fifth metatarsus
- Conditions
- Plantar Calcaneal Spur, Fasciitis, Plantar
- Being tested
- algometer
- Keywords
- plantar fasciitis, heel pain, manual treatment, dorsi flexion
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
algometerDevice
Also called SBMEDIC Electronics
Pressure algometer (Algometry) - This is an instrument that measures pain threshold (the minimum pressure required to produce pain). The instrument consists of a flat disk size centimeter square attached to pressure transducer and measuring electrodes. The disk is placed vertically on the point of pain and therapist increases the intensity of the pressure until initial pain appears (when sense of pressure becomes sense of pain.) Score is determined by average of three repeated measurements with 30 seconds break between each.
The algometer allows an objective assessment of pain in addition to LEFS score which is a subjective tool. The algometer test was found to be valid and reliable in repeated measurements (interrater, intrarater) by Andrew A. Fischerin 1987 with healthy people [Andrew 1987]. In another study high reliability was found for averaging between three repeated tests: ICC = 0.91 (CI 0.82; 0.97 95%). [Linda et al 2007]
| Study group | Role | What they receive |
|---|---|---|
| ankle mobilization for pain release | Experimental | stretching exercise for the plantar fascia and triceps surae muscles three times a day throughout the study period.
During each visit the exercise performance will be checked by the therapist. In addition, participants from both groups will get ultra sound therapy in frequency of 1 MHz, power of 1.5 watts per centimeter-squared, pulses of 50% for 5 minutes.
The study group will receive the same treatment and a number of manual techniques that include antero-posterior (AP) mobilization for talocrural joint in two variations (weight baring and non-weight baring) to improve the range of dorsi flexion, subtalar joint mobilization to improve range of eversion and mid-tarsal mobilization to improve pronation / supination of the forefoot. Each technique will be carried out for 1 to 1.5 minutes for a total of 5 minutes of manual treatment.
All patients will receive information and guidance to practice at home. Receives: Device: algometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale 0-10
The participant will rate his pain intensity at first step in the morning on a scale of numbers between 0-10 when 0 means "no pain" and 10 means "very severe pain". NPRS is a valid and reliable tool for assessment of pain intensity and is a common tool in studies on PF.
Measured: one year and two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar Calcaneal SpurStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services
- Responsible party
- Sponsor
- Investigators
- Anat Shashua, BPT, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439932
- Sponsor's protocol ID
- MMC11XXX-XXKCTIL
- Other IDs
- PF-001-ISR
- Status last verified
- Sep 2011
- First submitted
- 20 Sep 2011
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Shashua A, Flechter S, Avidan L, Ofir D, Melayev A, Kalichman L. The effect of additional ankle and midfoot mobilizations on plantar fasciitis: a randomized controlled trial. J Orthop Sports Phys Ther. 2015 Apr;45(4):265-72. doi: 10.2519/jospt.2015.5155. Epub 2015 Mar 4.
PubMed 25739844
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Manual Therapy Combined With Standard Treatment in the Management of Plantar Fasciitis, a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01439932
- Acronym / sponsor ID
- MMC11XXX-XXKCTIL
- Conditions
- Plantar Calcaneal Spur, Fasciitis, Plantar
- Keywords
- plantar fasciitis, heel pain, manual treatment, dorsi flexion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Clalit Health Services
- Study start
- Oct 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 23 Sep 2011 (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.
Background: Plantar fasciitis (PF) is a common problem that tends to attack about 10% of the population during life. This is a degenerative condition of the plantar fascia at its insertion at the bottom of the heel. Pain appears mainly on the first steps in the morning or after prolonged lack of weight bearing. The pain intensity can be very high and this can cause functional limitations and reduce quality of life.
Despite the high prevalence of the PF, treatment is controversial and not supported by extensive research. Review of the previous studies on various treatments, mentioned steroid injections, shock waves, night splint, orthotics, heel padding and stretching exercises.
Limitation of ankle dorsi flexion is a common finding and thought to be a contributing factor to the development of pathology. So far, this issue had been addressed mainly by soft tissue therapy techniques to improve ankle range of motion in patients with PF. Only one study (Joshua et al 2009) evaluated the effect of ankle joint mobilizations of PF. However, in this study mobilizations were part of complex therapy and therefore the effect of treatment cannot be attributed solely to them.
The purpose of this study is to evaluate the effectiveness of ankle and mid-foot joints mobilization on pain and function of patients with PF.
The hypothesis is that manual mobilizations of ankle and midfoot joints in addition to conventional physical therapy will improve pain and function significantly more than conventional treatment, in patients with PF.
Methods: 50 patients, age 18-75 with a diagnosis of PF that meet the inclusion criteria will be recruited and randomly divided into two groups. Both groups will receive commonly accepted physical therapy treatment that includes stretching exercise of the plantar fascia and triceps surae muscles and ultrasound therapy at the site of symptoms. The study group will receive in addition manual mobilizations to the ankle and midfoot joints. The procedures will take place at the physiotherapy clinic Bat-Yamon of General Health Services and will last four weeks, twice a week.
Detailed description
A prospective randomized double-blinded controlled clinical trial. Setting: Bat-Yamon physical therapy clinic of Clalit health services in Bat Yam.
Ethical considerations: The research proposal will be submitted for the approval of the Helsinki Committee at Meir Hospital in Kefar Saba. All patients will sign informed consent form according to the laws of medical ethics.
Subjects will be recruited from all the population of patients who are referred to physical therapy for the treatment of PF with diagnosis of plantar fasciitis or calcaneal spur.
Randomization will be carried out using envelopes that will be prepared in advance. Each patient will receive at the end of the baseline examination envelope with the type of treatment for which will be delivered only to the therapist so that the examiner and the patient will be blind to the treatment group.
Baseline and final evaluations will be performed by the examiner-therapist and treatments performed by three physical therapists at the Bat-Yamon clinic with experience of at least 3 years which will receive proper instruction and training.
Baseline examination will be performed after completing informed consent form and will include demographic information to be filled by patient, clinical interview and examination by the examiner. Demographic information includes age, gender, weight, BMI (calculated by the examiner), history of the problem, habits related to physical activity and occupation and general health.
The interview will refer to etiology and nature of symptoms. The clinical examination will include observation of foot structure and gait pattern, the presence of hit or swelling. Palpation for pain location and for ruling out fat pad Syndrome, clunk test and neurodynamic of tibial nerve will be performed to rule out tarsal tunnel syndrome (TTS). Patients with suspicion for one of these diagnoses will not be recruited. Dorsi flexion range of motion in both legs will be measured and compared to the range at the end of treatment. Measurement will be taken in two ways, once weight bearing with inclinometer - the patient stands in lounge position while tested leg in front and asked to bend the knee of this leg as possible without lifting the heel off the floor. The angle measured is the angle between the tibia and a vertical line to the floor.Second time without weight bearing with Goniometer- the patient lies on his back with a pillow under the tested knee , the therapist performs maximum dorsi flexion passively and asks the patient to add an active movement in the same direction. The angle measured is between fibula and fifth metatarsus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ankle mobilization for pain release | Experimental | Device: algometerstretching exercise for the plantar fascia and triceps surae muscles three times a day throughout the study period. During each visit the exercise performance will be checked by the therapist. In addition, participants from both groups will get ultra sound therapy in frequency of 1 MHz, power of 1.5 watts per centimeter-squared, pulses of 50% for 5 minutes. The study group will receive the same treatment and a number of manual techniques that include antero-posterior (AP) mobilization for talocrural joint in two variations (weight baring and non-weight baring) to improve the range of dorsi flexion, subtalar joint mobilization to improve range of eversion and mid-tarsal mobilization to improve pronation / supination of the forefoot. Each technique will be carried out for 1 to 1.5 minutes for a total of 5 minutes of manual treatment. All patients will receive information and guidance to practice at home. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75
- Pain allocated at the bottom of heel and produced by pressure
- Pain in the morning at first steps or after prolonged non-weight bearing
- NPRS morning pain score of 3 or higher
Key exclusion criteria (7 listed)
- Tumors
- Prolonged use of steroids
- Fracture below knee during the last year
- Prior foot surgeries
- A positive diagnosis of Tarsal Tunnel Syndrome (TTS) / Fat Pad Syndrome
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 |
|---|---|---|
| algometerAlso: SBMEDIC ElectronicsPressure algometer (Algometry) - This is an instrument that measures pain threshold (the minimum pressure required to produce pain). The instrument consists of a flat disk size centimeter square attached to pressure transducer and measuring electrodes. The disk is placed vertically on the point of pain and therapist increases the intensity of the pressure until initial pain appears (when sense of pressure becomes sense of pain.) Score is determined by average of three repeated measurements with 30 seconds break between each. The algometer allows an objective assessment of pain in addition to LEFS score which is a subjective tool. The algometer test was found to be valid and reliable in repeated measurements (interrater, intrarater) by Andrew A. Fischerin 1987 with healthy people [Andrew 1987]. In another study high reliability was found for averaging between three repeated tests: ICC = 0.91 (CI 0.82; 0.97 95%). [Linda et al 2007] | Device | ankle mobilization for pain release |
Primary outcome
Numeric Pain Rating Scale 0-10
Time frame: one year and two months
The participant will rate his pain intensity at first step in the morning on a scale of numbers between 0-10 when 0 means "no pain" and 10 means "very severe pain". NPRS is a valid and reliable tool for assessment of pain intensity and is a common tool in studies on PF.
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 20 Feb 2013.
- Derived from this study: PubMed 25739844Shashua A, Flechter S, Avidan L, Ofir D, Melayev A, Kalichman L. The effect of additional ankle and midfoot mobilizations on plantar fasciitis: a randomized controlled trial. J Orthop Sports Phys Ther. 2015 Apr;45(4):265-72. doi: 10.2519/jospt.2015.5155. Epub 2015 Mar 4.
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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.
Anat Shashua, BPT study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing algometer in people with Plantar Calcaneal Spur and Fasciitis, Plantar, run by Meir Medical Center at 1 site in Israel.
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 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: finished, as of the sponsor's last update on 20 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 Israel. 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?
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?
Numeric Pain Rating Scale 0-10 (time frame: one year and two months). 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 NCT01439932, which also lists 1 linked publication.
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 20 Feb 2013.