Plantar FascitisNCT03367468
Conservative Therapy Interventions in Plantar Fasciitis
A study testing Exercise and Mobilization in people with Plantar Fascitis and Pain, run by Sulenur Yildiz at 1 site in Turkey (Türkiye).
Trial summary
Plantar fasciitis is seen common in clinics and responsible from most of foot related pain problems. There are many treatment modalities in the literature as well as there is no golden standard to treat plantar fasciitis in non-surgical ways. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plantar Fascitis, Pain
- What is being tested?
- Exercise and Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2018to 15 Mar 2020
- 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
- Older than 18 years, Baseline Roles and Maudsley score > 2, Accepting and signing consent form Daily usage of insoles which was prescribed by doctor No history of systemic disease and surgery that affects foot biomechanics No history of cognitive, mental, neurological or psychological problems.
Who cannot join
- Presence of chronic or active infection in treatment site, Not accepting to participate in the study Systemic, neurologic, rheumatologic,and vascular disease history, Pregnancy, BMI > 35 kg/m2, History of foot and/or ankle surgery.
Trial locations and contacts
1 site in 1 country.
Nilgun BEK, PT, PhD, Professor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, 06100
Sulenur YILDIZ, PT, MSc, sulenur.subasi@hacettepe.edu.tr
About this study
Official title: Comparison of the Different Conservative Therapy Interventions in Plantar Fasciitis
Plantar fasciitis is seen common in clinics and responsible from most of foot related pain problems. There are many treatment modalities in the literature as well as there is no golden standard to treat plantar fasciitis in non-surgical ways. The aim of this study is to compare intensive physiotherapy program, home based exercise program and control group decide the most effective rehabilitation program in plantar fasciitis.
Read the detailed description
Plantar fasciitis is frequently seen in adult population as a pain related problem of the foot. Pain, as a most prominent symptom, is caused from repetitive microtraumas and inflammation where plantar fascia attaches to the calcaneus. Pain starts from heel pad or medial tubercule of the calcaneus and spreads through plantar fascia and medial longitudinal arch.
Obesity, increased foot pronation, difference in extremity length, long standing duration and Achilles tendon tightness are some of the factors which stress plantar fascia and sometimes cause degenerative changes on it. Weakness of intrinsic muscle is also another factor which is thought to be related with plantar fasciitis.
Diagnosis is mostly depends on history and physical examination. First steps in the morning, walking after long rest, and palpation of medial tubercule of calcaneus are painful.
According to the literature, non-surgical treatment modalities relieve symptoms of patients successfully. Orthotics, night splints, manipulation interventions with conventional methods are effective to decrease pain and improve function. There are various physiotherapy treatment approaches in plantar fasciitis but there is no consensus about most effective treatment program. Stretching of plantar flexor muscles and plantar fascia is one of the core elements of the treatment plan. Strengthening exercises together with stretching were shown more effective than only stretching. Foot orthoses are thought to prevent increased pronation and relieving stress on plantar fascia in patients with plantar fasciitis. Usage of insoles with night splints is found more effective. Taping is also helpful to acute pain control. Short foot exercises as isolated intrinsic foot muscles strengthening helps to providing subtalar foot position and supports plantar fascia and foot arches. Manual techniques improve lower extremity joint mobility and decreases related pain. Extracorporeal Shock Wave Therapy is suggested to try after at least six month ineffective conservative treatments. If symptoms resist more than six months and non-conservative treatments are found ineffective, invasive approaches as steroid injections are applicable.
Treatment of this common problem in population is important to ensure patients returning in earliest period to daily life with full physical capacity. There are many conservative options to treat plantar fasciitis but best treatment program combination was not clear The aim of this study is to compare intensive physiotherapy program, home based exercise program and control group decide the most effective rehabilitation program in plantar fasciitis.
- Conditions
- Plantar Fascitis, Pain
- Being tested
- Exercise, Mobilization
- Keywords
- Plantar fascitis, Pain, Exercise, Physiotherapy, Quality of life
- Medical subject headings
- Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Strengthening exercises ( extrinsic and intrinsic foot muscles) Stretcthing exercises (plantar fascia, plantar flexor muscles)
MobilizationOther
Antero-posterior gliding, talocrural traction, metatarsal mobilization
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy group | Active comparator | Strengthening and stretching exercises,cross friction massage (supervised by physiotherapist) Mobilization techniques Daily usage of prescribed orthotic insole Receives: Other: Exercise; Other: Mobilization |
| Home exercise group | Active comparator | Strenthening and stretching exercises Daily usage of prescribed orthotic insole Receives: Other: Mobilization |
| Control group | No intervention | Follow ups Daily usage of prescribed orthotic insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of pain
Perception of pain with Visual Analog Scale (VAS) with palpation, first steps in the morning and after long walk.
The Visual Analog Scale is a valid and reliable measure of pain intensity. To rate pain intensity a mark is placed on a 100-mm VAS. The VAS is horizontally positioned with the extremes labeled''least possible pain'' and ''worst possible pain. Using a ruler, the score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Subjects will be asked to rate pain in three different conditions as palpation, first steps in the morning and after long walk.
Measured: 6 weeks
Secondary outcomes (1)
Perception of quality of life
The World Health Organization (WHO) Quality of Life - Bref Questionnaire is a 26-item self-administered instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. Higher score presents better quality of life.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start15 Jul 2018
- Primary completion15 Dec 2019 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sulenur Yildiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sulenur Yildiz, Hacettepe University
- Investigators
- Nilgun BEK, PT, PhD, Professor, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367468
- Sponsor's protocol ID
- 06144834
- Status last verified
- Oct 2019
- First submitted
- 10 Nov 2017
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pfeffer G, Bacchetti P, Deland J, Lewis A, Anderson R, Davis W, Alvarez R, Brodsky J, Cooper P, Frey C, Herrick R, Myerson M, Sammarco J, Janecki C, Ross S, Bowman M, Smith R. Comparison of custom and prefabricated orthoses in the initial treatment of proximal plantar fasciitis. Foot Ankle Int. 1999 Apr;20(4):214-21. doi: 10.1177/107110079902000402.
PubMed 10229276Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.
PubMed 21916393Podolsky R, Kalichman L. Taping for plantar fasciitis. J Back Musculoskelet Rehabil. 2015;28(1):1-6. doi: 10.3233/BMR-140485.
PubMed 24867905Thomas JL, Christensen JC, Kravitz SR, Mendicino RW, Schuberth JM, Vanore JV, Weil LS Sr, Zlotoff HJ, Bouche R, Baker J; American College of Foot and Ankle Surgeons heel pain committee. The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. J Foot Ankle Surg. 2010 May-Jun;49(3 Suppl):S1-19. doi: 10.1053/j.jfas.2010.01.001.
PubMed 20439021Martin RL, Davenport TE, Reischl SF, McPoil TG, Matheson JW, Wukich DK, McDonough CM; American Physical Therapy Association. Heel pain-plantar fasciitis: revision 2014. J Orthop Sports Phys Ther. 2014 Nov;44(11):A1-33. doi: 10.2519/jospt.2014.0303.
PubMed 25361863Digiovanni BF, Nawoczenski DA, Malay DP, Graci PA, Williams TT, Wilding GE, Baumhauer JF. Plantar fascia-specific stretching exercise improves outcomes in patients with chronic plantar fasciitis. A prospective clinical trial with two-year follow-up. J Bone Joint Surg Am. 2006 Aug;88(8):1775-81. doi: 10.2106/JBJS.E.01281.
PubMed 16882901Sweeting D, Parish B, Hooper L, Chester R. The effectiveness of manual stretching in the treatment of plantar heel pain: a systematic review. J Foot Ankle Res. 2011 Jun 25;4:19. doi: 10.1186/1757-1146-4-19.
PubMed 21703003Cheung RT, Sze LK, Mok NW, Ng GY. Intrinsic foot muscle volume in experienced runners with and without chronic plantar fasciitis. J Sci Med Sport. 2016 Sep;19(9):713-5. doi: 10.1016/j.jsams.2015.11.004. Epub 2015 Nov 22.
PubMed 26655866Moon DC, Kim K, Lee SK. Immediate Effect of Short-foot Exercise on Dynamic Balance of Subjects with Excessively Pronated Feet. J Phys Ther Sci. 2014 Jan;26(1):117-9. doi: 10.1589/jpts.26.117. Epub 2014 Feb 6.
PubMed 24567688McKeon PO, Fourchet F. Freeing the foot: integrating the foot core system into rehabilitation for lower extremity injuries. Clin Sports Med. 2015 Apr;34(2):347-61. doi: 10.1016/j.csm.2014.12.002. Epub 2015 Jan 24.
PubMed 25818718Bennett PJ, Patterson C, Wearing S, Baglioni T. Development and validation of a questionnaire designed to measure foot-health status. J Am Podiatr Med Assoc. 1998 Sep;88(9):419-28. doi: 10.7547/87507315-88-9-419.
PubMed 9770933
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Different Conservative Therapy Interventions in Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT03367468
- Acronym / sponsor ID
- 06144834
- Conditions
- Plantar Fascitis, Pain
- Keywords
- Plantar fascitis, Pain, Exercise, Physiotherapy, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Sulenur YildizUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 8 Dec 2017 (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 seen common in clinics and responsible from most of foot related pain problems. There are many treatment modalities in the literature as well as there is no golden standard to treat plantar fasciitis in non-surgical ways. The aim of this study is to compare intensive physiotherapy program, home based exercise program and control group decide the most effective rehabilitation program in plantar fasciitis.
Detailed description
Plantar fasciitis is frequently seen in adult population as a pain related problem of the foot. Pain, as a most prominent symptom, is caused from repetitive microtraumas and inflammation where plantar fascia attaches to the calcaneus. Pain starts from heel pad or medial tubercule of the calcaneus and spreads through plantar fascia and medial longitudinal arch.
Obesity, increased foot pronation, difference in extremity length, long standing duration and Achilles tendon tightness are some of the factors which stress plantar fascia and sometimes cause degenerative changes on it. Weakness of intrinsic muscle is also another factor which is thought to be related with plantar fasciitis.
Diagnosis is mostly depends on history and physical examination. First steps in the morning, walking after long rest, and palpation of medial tubercule of calcaneus are painful.
According to the literature, non-surgical treatment modalities relieve symptoms of patients successfully. Orthotics, night splints, manipulation interventions with conventional methods are effective to decrease pain and improve function. There are various physiotherapy treatment approaches in plantar fasciitis but there is no consensus about most effective treatment program. Stretching of plantar flexor muscles and plantar fascia is one of the core elements of the treatment plan. Strengthening exercises together with stretching were shown more effective than only stretching. Foot orthoses are thought to prevent increased pronation and relieving stress on plantar fascia in patients with plantar fasciitis. Usage of insoles with night splints is found more effective. Taping is also helpful to acute pain control. Short foot exercises as isolated intrinsic foot muscles strengthening helps to providing subtalar foot position and supports plantar fascia and foot arches. Manual techniques improve lower extremity joint mobility and decreases related pain. Extracorporeal Shock Wave Therapy is suggested to try after at least six month ineffective conservative treatments. If symptoms resist more than six months and non-conservative treatments are found ineffective, invasive approaches as steroid injections are applicable.
Treatment of this common problem in population is important to ensure patients returning in earliest period to daily life with full physical capacity. There are many conservative options to treat plantar fasciitis but best treatment program combination was not clear The aim of this study is to compare intensive physiotherapy program, home based exercise program and control group decide the most effective rehabilitation program in plantar fasciitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy group | Active comparator | Other: Exercise, Other: MobilizationStrengthening and stretching exercises,cross friction massage (supervised by physiotherapist) Mobilization techniques Daily usage of prescribed orthotic insole |
| Home exercise group | Active comparator | Other: MobilizationStrenthening and stretching exercises Daily usage of prescribed orthotic insole |
| Control group | No intervention | –Follow ups Daily usage of prescribed orthotic insole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Older than 18 years, Baseline Roles and Maudsley score > 2, Accepting and signing consent form Daily usage of insoles which was prescribed by doctor No history of systemic disease and surgery that affects foot biomechanics No history of cognitive, mental, neurological or psychological problems.
Key exclusion criteria (1 listed)
- Presence of chronic or active infection in treatment site, Not accepting to participate in the study Systemic, neurologic, rheumatologic,and vascular disease history, Pregnancy, BMI > 35 kg/m2, History of foot and/or ankle surgery.
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 |
|---|---|---|
| ExerciseStrengthening exercises ( extrinsic and intrinsic foot muscles) Stretcthing exercises (plantar fascia, plantar flexor muscles) | Other | Physiotherapy group |
| MobilizationAntero-posterior gliding, talocrural traction, metatarsal mobilization | Other | Home exercise group, Physiotherapy group |
Primary outcome
Perception of pain
Time frame: 6 weeks
Perception of pain with Visual Analog Scale (VAS) with palpation, first steps in the morning and after long walk. The Visual Analog Scale is a valid and reliable measure of pain intensity. To rate pain intensity a mark is placed on a 100-mm VAS. The VAS is horizontally positioned with the extremes labeled''least possible pain'' and ''worst possible pain. Using a ruler, the score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Subjects will be asked to rate pain in three different conditions as palpation, first steps in the morning and after long walk.
1 secondary outcome
Perception of quality of life
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Background: PubMed 10229276Pfeffer G, Bacchetti P, Deland J, Lewis A, Anderson R, Davis W, Alvarez R, Brodsky J, Cooper P, Frey C, Herrick R, Myerson M, Sammarco J, Janecki C, Ross S, Bowman M, Smith R. Comparison of custom and prefabricated orthoses in the initial treatment of proximal plantar fasciitis. Foot Ankle Int. 1999 Apr;20(4):214-21. doi: 10.1177/107110079902000402.
- Background: PubMed 21916393Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.
- Background: PubMed 24867905Podolsky R, Kalichman L. Taping for plantar fasciitis. J Back Musculoskelet Rehabil. 2015;28(1):1-6. doi: 10.3233/BMR-140485.
- Background: PubMed 20439021Thomas JL, Christensen JC, Kravitz SR, Mendicino RW, Schuberth JM, Vanore JV, Weil LS Sr, Zlotoff HJ, Bouche R, Baker J; American College of Foot and Ankle Surgeons heel pain committee. The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. J Foot Ankle Surg. 2010 May-Jun;49(3 Suppl):S1-19. doi: 10.1053/j.jfas.2010.01.001.
- Background: PubMed 25361863Martin RL, Davenport TE, Reischl SF, McPoil TG, Matheson JW, Wukich DK, McDonough CM; American Physical Therapy Association. Heel pain-plantar fasciitis: revision 2014. J Orthop Sports Phys Ther. 2014 Nov;44(11):A1-33. doi: 10.2519/jospt.2014.0303.
- Background: PubMed 16882901Digiovanni BF, Nawoczenski DA, Malay DP, Graci PA, Williams TT, Wilding GE, Baumhauer JF. Plantar fascia-specific stretching exercise improves outcomes in patients with chronic plantar fasciitis. A prospective clinical trial with two-year follow-up. J Bone Joint Surg Am. 2006 Aug;88(8):1775-81. doi: 10.2106/JBJS.E.01281.
- Background: PubMed 21703003Sweeting D, Parish B, Hooper L, Chester R. The effectiveness of manual stretching in the treatment of plantar heel pain: a systematic review. J Foot Ankle Res. 2011 Jun 25;4:19. doi: 10.1186/1757-1146-4-19.
- Background: PubMed 26655866Cheung RT, Sze LK, Mok NW, Ng GY. Intrinsic foot muscle volume in experienced runners with and without chronic plantar fasciitis. J Sci Med Sport. 2016 Sep;19(9):713-5. doi: 10.1016/j.jsams.2015.11.004. Epub 2015 Nov 22.
- Background: PubMed 24567688Moon DC, Kim K, Lee SK. Immediate Effect of Short-foot Exercise on Dynamic Balance of Subjects with Excessively Pronated Feet. J Phys Ther Sci. 2014 Jan;26(1):117-9. doi: 10.1589/jpts.26.117. Epub 2014 Feb 6.
- Background: PubMed 25818718McKeon PO, Fourchet F. Freeing the foot: integrating the foot core system into rehabilitation for lower extremity injuries. Clin Sports Med. 2015 Apr;34(2):347-61. doi: 10.1016/j.csm.2014.12.002. Epub 2015 Jan 24.
- Background: PubMed 9770933Bennett PJ, Patterson C, Wearing S, Baglioni T. Development and validation of a questionnaire designed to measure foot-health status. J Am Podiatr Med Assoc. 1998 Sep;88(9):419-28. doi: 10.7547/87507315-88-9-419.
- Individual participant dataSharing planned: No
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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.
Nilgun BEK, PT, PhD, Professor contact
Nilgun BEK, PT, PhD, Professor study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Mobilization in people with Plantar Fascitis and Pain, run by Sulenur Yildiz 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 1 inclusion and 1 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 10 Oct 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sulenur YILDIZ, PT, MSc (+903123051576 ext. 139, sulenur.subasi@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of pain (time frame: 6 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 NCT03367468, which also lists 11 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 10 Oct 2019.