Plantar Fasciitis of Both FeetTDPSFPFMRNCT06754982
Temporal Differences in Pain, Muscle Stiffness, and Function in Subjects With Plantar Fasciitis After Myofascial Release Therapy
A study testing Myofascial release in people with Plantar Fasciitis of Both Feet, run by Universidad Católica del Maule at 1 site in Chile.
Trial summary
Plantar fasciitis (PF) is a common condition in the population. One of the interventions used to resolve this condition is myofascial release (MR), which consists of massages that help reduce pain and increase mobility. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Plantar Fasciitis of Both Feet
- What is being tested?
- Myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- 31 Jan 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Study participants must be diagnosed with PF
- Age between 18 to 60 years a clinical diagnosis of unilateral PF according to the clinical practice guidelines of the orthopedic section of the American Physical Therapy Association (APTA).
- Pain intensity > 2 on the numerical pain rating scale (NPRS).
- Pain that is most intense upon awakening and decreases during walking. • Duration of pain greater than 3 months and less than 7 months.
- Both sexes.
Who cannot join
- Who have received ankle or foot interventions within the previous three months, such as physical therapy (manual therapy, exercise, physical agents), injections, long-term history of steroid use.
- History of surgery on the ankle, foot, or inner leg.
- Other causes of heel pain: arthritic (fibromyalgia, gout, rheumatoid arthritis, seronegative spondyloarthropathies), infectious (diabetic ulcers, osteomyelitis, plantar warts), neurological (lumbar radiculopathy (L4-S2), nerve entrapment (branches of posterior tibial nerve), neuroma, tarsal tunnel syndrome, (posterior tibial nerve), trauma (calcaneal stress fracture), tumor (Ewing's sarcoma, neuroma), vascular and pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Clinical Research Laboratory, Department of Physical Therapy, Faculty of Health Sciences
Talca, Maule Region, 3460000
Ignacio Andrés Gajardo Valenzuela, Magíster, +56993263470, igajardovalen@gmail.com
About this study
Plantar fasciitis (PF) is a common condition in the population. One of the interventions used to resolve this condition is myofascial release (MR), which consists of massages that help reduce pain and increase mobility. MR has shown efficacy when applied for 30 minutes, however, it is necessary to compare it with a 15-minute MR intervention, since in clinical practice optimizing time is essential. Accordingly, the present research seeks to evaluate whether there are differences in the application time of myofascial release in people with PF.
Read the detailed description
Plantar fasciitis (PF) is an acute inflammation of the fascia resulting from degenerative irritation from the median tuberosity of the heel bone to surrounding perifascial structures. Histological findings include granulation tissue, microtears, collagen disorders, and in particular a lack of normal inflammation. It is one of the most common causes of musculoskeletal pain, with a population prevalence in adults aged 50 years or older of 9.6% (95% CI: 8.8 to 10.5) and a population prevalence of disabling pain of 7.9% (95% CI: 7.1 to 8.7), slightly more present in women than in men, with a history of knee, hip, and back pain. It is characterized by pain on the first step and pain during weight-bearing tasks, particularly after periods of rest. Among the possible low-cost and noninvasive treatments that have shown efficacy Manual therapy (MT) is a popular treatment for PF. TM includes treatments such as joint and soft tissue mobilizations, manipulations, myofascial trigger point release, and stretch-contraction-relaxation. In particular, myofascial release is a gradual soft tissue stretching by the clinician that is guided entirely by feedback from the recipient's body to determine the direction, strength, and duration of the stretch to address specific soft tissue restrictions.
TM has been frequently used to treat PF, systematic reviews have reported positive results on pain, function, and pressure pain threshold, but suggest that they should be viewed with caution due to poor methodological quality, intervention heterogeneity in dosing (frequency, intensity, and duration), techniques, and outcome measures, and the frequent use of secondary manual therapy co-interventions. The application of myofascial release is varied in the number of procedures, application time of each technique and total application time of the intervention, without a clear justification regarding the decision of each of these options. A clinical trial applied a protocol for 4 weeks, where each session was performed in 30 minutes, and demonstrated that myofascial release is more effective than the control group, presenting a change in the average pressure pain threshold of 1.3 kg/cm2 at the end of the 4-week treatment. This change is considered clinically important, given that in the literature it has been reported that this difference is > 1.16 kg/cm2. However, the reason for the time used, the number of techniques and the choice of techniques is not justified. In addition, there are no investigations in the literature on the specific effect of myofascial release with a shorter application time in PF. On the other hand, studies with deep massage, a manual therapy technique, combined with flexibility exercise has proven to be effective with an execution time of 10 minutes. Under this context and considering that in clinical practice the optimization of times is essential, it is relevant to carry out a clinical equivalence trial that allows to determine the efficacy of isolated myofascial release in PF, with a 30-minute intervention protocol already carried out and that demonstrated positive effects on the pressure pain threshold, contrasted with a time of less than 15 minutes. Given the context raised, the question arises: In participants with plantar fasciitis, would the application of a myofascial release treatment for 15 minutes have equivalent effects to myofascial release applied for 30 minutes, in the pain and stiffness of the gastrocnemius muscle?
- Conditions
- Plantar Fasciitis of Both Feet
- Being tested
- Myofascial release
- Keywords
- Plantar fasciitis, Myofascial release, manual therapy
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial releaseOther
Nine myofascial release techniques will be applied to each group: Transverse hamstring play; Transverse hamstring and adductor magnus play: posterior to anterior pressure; Transverse gastrocnemius-soleus play; Tibia bone clearing: posterior tibia; Tibia bone clearing: prone grip with half chisel; Lateral fascial distraction of the tibia; Lateral elongation of the peroneal tissue; Cross-friction of the gastrocnemius-soleus musculotendinous junction; Manipulation of the plantar fascia.
| Study group | Role | What they receive |
|---|---|---|
| Group 15 minutes | Experimental | The group will receive 15 minutes of myofascial release. Each intervention will be performed only on the affected limb. 9 myofascial release techniques will be applied to each group, each procedure will last 1 minute and 40 seconds. Receives: Other: Myofascial release |
| Gruops 30 minutes | Experimental | The group will receive 30 minutes of myofascial release. Each intervention will be performed only on the affected limb. Nine myofascial release techniques will be applied to each group, each procedure will last 3 minutes and 20 seconds. Receives: Other: Myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morning pain intensity measured with the Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) measures pain intensity from 0 to 11 points (0, no pain; 10, worst pain imaginable).(18) Numeric pain scales have been shown to be reliable and valid.(25) In addition, the DCMI (minimally clinically important difference) has been reported to be 2 points.(26)
Measured: It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
Secondary outcomes (6)
Pressure pain threshold (PPT)
The pressure pain threshold (PPT), defined as the minimum pressure to induce a change from a pressure sensation to a pain sensation.(27) The score is obtained from the average of 3 repeated measurements, with a 30 second rest between each one, a method that has demonstrated validity and high reliability with ICC=0.91 (95% CI: 0.82, 0.97).(19, 28) The PPT will be evaluated with an Algometer (Wagner Instruments FPX 50). The pressure (force divided by the surface area) will be applied at a speed of approximately 1kg/cm2/s. It will be measured on the most sensitive point of the lower surface of the calcaneus, posterior surface of the calcaneus, soleus muscle and internal and lateral gastrocnemius muscle.(13, 29) To measure each of these points, the subject must be placed face down on the stretcher, with the extremity to be evaluated uncovered.
Measured: It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
Calf muscle stiffness (Silfverskiöl test)
Gastrocnemius stiffness or tightness will be assessed with the Silfverskiöld test.(20)The measurement explores the degree of passive dorsiflexion of the ankle in the supine position (with a goniometer), in two positions: with the knee extended and flexed (90°), where the hindfoot is in a neutral or varus position. A moderate force load is applied under the forefoot (it is recommended to apply the goniometric measurement with a force between 1.7 and 2kg),(30) the expected difference for the test to be positive is a minimum of 13 degrees of difference.(20) The reliability at the intra-evaluator level with ICC (95% CI) that fluctuates between 0.845 to 0.924.(31) A digital goniometer will be used (brand: baseline evaluation instruments; model: 12-1027; company: enterprises; Country: USA).
Measured: It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
Functionality (Foot Function Index (FFI))
Functionality will be assessed through the Foot Function Index (FFI), recommended for subjects who suffer from heel pain,(5) and validated in Spanish.(21) It is a self-administered index consisting of 23 items that measure pain, disability and activity restriction, which has been shown to be reliable, valid and sensitive to foot alterations.(34-36)
Measured: It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
Health-related quality of life (SF-12)
Health-related quality of life will be assessed with the SF-12 health questionnaire, which is a shortened version of the SF-36. This scale has 12 items with Likert-style response opinions (3 to 6 points) and a dichotomous scale, it has two summary components, physical (PCS) and mental (MCS), and it summarizes 8 dimensions: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health. The maximum score of the survey indicates good quality of life and is valid in Spanish (correlation with back pain PCS-12 (r= -0.405, P<0.001) and MCS-12 (r=-0.326, P=0.0001)) and reliable (Cronbach's alpha coefficient PCS-12 was 0.77 and MCS-12 was 0.8), in patients with musculoskeletal pain.
Measured: It will be measured at Baseline, at 4 weeks and at 4 weeks after the end of the treatment
Perception of change (Patient Global Impression of Change)
Satisfaction after the intervention is measured through the perception of change after the intervention, applying the scale "Patient Global Impression of Change" (PGIC). The results will reflect the patient's belief about the effect of the applied treatment. (22) The scale consists of a 7-point verbal scale, with the options "I have improved a lot", "I have improved quite a bit", "I have improved a little", "I am the same", "I have worsened a little", "I have worsened quite a bit" and "I have worsened a lot". (37, 38) A clinically significant improvement is considered to be achieved when the items "I have improved a lot", "I have improved quite a bit" are scored. The test-retest reliability of the global rating of the change scales is excellent (ICC=0.90). (39)
Measured: It will be measured at at 4 weeks and at 4 weeks after the end of the treatment
Foot health (Foot Health Status Questionnaire (FHSQ)
Foot health will be measured with the "Foot Health Status Questionnaire (FHSQ)" questionnaire, this scale is validated in Spanish. (24) In addition, it has been shown to have content validity, construct validity, reliability and good responsiveness in patients with plantar fasciitis, who were users of orthopedic physiotherapy.(40)
Measured: It will be measured at Baseline, at 4 weeks and at 4 weeks after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start31 Jan 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Plantar Fasciitis of Both FeetStudies 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
- Model description
- A randomized, two-group parallel equivalence clinical trial will be conducted. Participants will be randomly assigned to one of two groups, 15 minutes of myofascial release, 30 minutes of myofascial release. In order to establish equivalence between groups, the equivalence limit or tolerance range will be adopted so that the groups do not present more than half of the value of the main variable that can be used in a superiority test (12). Therefore, for this research the adopted value will be 0.65 kg/cm2 in the pressure pain threshold, because an average change of 1.3 kg/cm2 has been observed.(10) Randomization and evaluations will be carried out by external assistants.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica del Maule
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Gajardo Valenzuela, Universidad Católica del Maule
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754982
- Sponsor's protocol ID
- N°116/2023
- Acronym
- TDPSFPFMR
- Status last verified
- Mar 2025
- First submitted
- 15 Nov 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The demographic characteristics and the data regarding the main variable and the secondary variables of the participants will be shared.
Publications
Kinney AR, Eakman AM, Graham JE. Novel Effect Size Interpretation Guidelines and an Evaluation of Statistical Power in Rehabilitation Research. Arch Phys Med Rehabil. 2020 Dec;101(12):2219-2226. doi: 10.1016/j.apmr.2020.02.017. Epub 2020 Apr 6.
PubMed 32272106Cohen J. Statistical Power Analysis for the Behavioral Sciences: L. Erlbaum Associates; 1988.
Flight L, Julious SA. Practical guide to sample size calculations: non-inferiority and equivalence trials. Pharm Stat. 2016 Jan-Feb;15(1):80-9. doi: 10.1002/pst.1716. Epub 2015 Nov 25.
PubMed 26604186Martin RL, Irrgang JJ. A survey of self-reported outcome instruments for the foot and ankle. J Orthop Sports Phys Ther. 2007 Feb;37(2):72-84. doi: 10.2519/jospt.2007.2403.
PubMed 17366962Kamper D, Barin K, Parnianpour M, Reger S, Weed H. Preliminary investigation of the lateral postural stability of spinal cord-injured individuals subjected to dynamic perturbations. Spinal Cord. 1999 Jan;37(1):40-6. doi: 10.1038/sj.sc.3100747.
PubMed 10025694Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
PubMed 18055266Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum. 2001 Aug;45(4):384-91. doi: 10.1002/1529-0131(200108)45:43.0.CO;2-0.
PubMed 11501727Budiman-Mak E, Conrad KJ, Mazza J, Stuck RM. A review of the foot function index and the foot function index - revised. J Foot Ankle Res. 2013 Feb 1;6(1):5. doi: 10.1186/1757-1146-6-5.
PubMed 23369667Saag KG, Saltzman CL, Brown CK, Budiman-Mak E. The Foot Function Index for measuring rheumatoid arthritis pain: evaluating side-to-side reliability. Foot Ankle Int. 1996 Aug;17(8):506-10. doi: 10.1177/107110079601700814.
PubMed 8863033Budiman-Mak E, Conrad KJ, Roach KE. The Foot Function Index: a measure of foot pain and disability. J Clin Epidemiol. 1991;44(6):561-70. doi: 10.1016/0895-4356(91)90220-4.
PubMed 2037861Luo X, George ML, Kakouras I, Edwards CL, Pietrobon R, Richardson W, Hey L. Reliability, validity, and responsiveness of the short form 12-item survey (SF-12) in patients with back pain. Spine (Phila Pa 1976). 2003 Aug 1;28(15):1739-45. doi: 10.1097/01.BRS.0000083169.58671.96.
PubMed 12897502Schmidt S, Vilagut G, Garin O, Cunillera O, Tresserras R, Brugulat P, Mompart A, Medina A, Ferrer M, Alonso J. [Reference guidelines for the 12-Item Short-Form Health Survey version 2 based on the Catalan general population]. Med Clin (Barc). 2012 Dec 8;139(14):613-25. doi: 10.1016/j.medcli.2011.10.024. Epub 2012 Jan 11. Spanish.
PubMed 22244683DiGiovanni CW, Kuo R, Tejwani N, Price R, Hansen ST Jr, Cziernecki J, Sangeorzan BJ. Isolated gastrocnemius tightness. J Bone Joint Surg Am. 2002 Jun;84(6):962-70. doi: 10.2106/00004623-200206000-00010.
PubMed 12063330AlKhadhrawi N, Alshami A. Effects of myofascial trigger point dry cupping on pain and function in patients with plantar heel pain: A randomized controlled trial. J Bodyw Mov Ther. 2019 Jul;23(3):532-538. doi: 10.1016/j.jbmt.2019.05.016. Epub 2019 May 23.
PubMed 31563366Chesterton LS, Sim J, Wright CC, Foster NE. Interrater reliability of algometry in measuring pressure pain thresholds in healthy humans, using multiple raters. Clin J Pain. 2007 Nov-Dec;23(9):760-6. doi: 10.1097/AJP.0b013e318154b6ae.
PubMed 18075402
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Differences in Pain, Muscle Stiffness, and Function in Subjects With Plantar Fasciitis After Myofascial Release Therapy
- ClinicalTrials.gov ID
- NCT06754982
- Acronym / sponsor ID
- TDPSFPFMR / N°116/2023
- Conditions
- Plantar Fasciitis of Both Feet
- Keywords
- Plantar fasciitis, Myofascial release, manual therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad Católica del MauleUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 1 Jan 2025 (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 (PF) is a common condition in the population. One of the interventions used to resolve this condition is myofascial release (MR), which consists of massages that help reduce pain and increase mobility. MR has shown efficacy when applied for 30 minutes, however, it is necessary to compare it with a 15-minute MR intervention, since in clinical practice optimizing time is essential. Accordingly, the present research seeks to evaluate whether there are differences in the application time of myofascial release in people with PF.
Detailed description
Plantar fasciitis (PF) is an acute inflammation of the fascia resulting from degenerative irritation from the median tuberosity of the heel bone to surrounding perifascial structures. Histological findings include granulation tissue, microtears, collagen disorders, and in particular a lack of normal inflammation. It is one of the most common causes of musculoskeletal pain, with a population prevalence in adults aged 50 years or older of 9.6% (95% CI: 8.8 to 10.5) and a population prevalence of disabling pain of 7.9% (95% CI: 7.1 to 8.7), slightly more present in women than in men, with a history of knee, hip, and back pain. It is characterized by pain on the first step and pain during weight-bearing tasks, particularly after periods of rest. Among the possible low-cost and noninvasive treatments that have shown efficacy Manual therapy (MT) is a popular treatment for PF. TM includes treatments such as joint and soft tissue mobilizations, manipulations, myofascial trigger point release, and stretch-contraction-relaxation. In particular, myofascial release is a gradual soft tissue stretching by the clinician that is guided entirely by feedback from the recipient's body to determine the direction, strength, and duration of the stretch to address specific soft tissue restrictions.
TM has been frequently used to treat PF, systematic reviews have reported positive results on pain, function, and pressure pain threshold, but suggest that they should be viewed with caution due to poor methodological quality, intervention heterogeneity in dosing (frequency, intensity, and duration), techniques, and outcome measures, and the frequent use of secondary manual therapy co-interventions. The application of myofascial release is varied in the number of procedures, application time of each technique and total application time of the intervention, without a clear justification regarding the decision of each of these options. A clinical trial applied a protocol for 4 weeks, where each session was performed in 30 minutes, and demonstrated that myofascial release is more effective than the control group, presenting a change in the average pressure pain threshold of 1.3 kg/cm2 at the end of the 4-week treatment. This change is considered clinically important, given that in the literature it has been reported that this difference is > 1.16 kg/cm2. However, the reason for the time used, the number of techniques and the choice of techniques is not justified. In addition, there are no investigations in the literature on the specific effect of myofascial release with a shorter application time in PF. On the other hand, studies with deep massage, a manual therapy technique, combined with flexibility exercise has proven to be effective with an execution time of 10 minutes. Under this context and considering that in clinical practice the optimization of times is essential, it is relevant to carry out a clinical equivalence trial that allows to determine the efficacy of isolated myofascial release in PF, with a 30-minute intervention protocol already carried out and that demonstrated positive effects on the pressure pain threshold, contrasted with a time of less than 15 minutes. Given the context raised, the question arises: In participants with plantar fasciitis, would the application of a myofascial release treatment for 15 minutes have equivalent effects to myofascial release applied for 30 minutes, in the pain and stiffness of the gastrocnemius muscle?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, two-group parallel equivalence clinical trial will be conducted. Participants will be randomly assigned to one of two groups, 15 minutes of myofascial release, 30 minutes of myofascial release. In order to establish equivalence between groups, the equivalence limit or tolerance range will be adopted so that the groups do not present more than half of the value of the main variable that can be used in a superiority test (12). Therefore, for this research the adopted value will be 0.65 kg/cm2 in the pressure pain threshold, because an average change of 1.3 kg/cm2 has been observed.(10) Randomization and evaluations will be carried out by external assistants.
| Arm | Type | Receives |
|---|---|---|
| Group 15 minutes | Experimental | Other: Myofascial releaseThe group will receive 15 minutes of myofascial release. Each intervention will be performed only on the affected limb. 9 myofascial release techniques will be applied to each group, each procedure will last 1 minute and 40 seconds. |
| Gruops 30 minutes | Experimental | Other: Myofascial releaseThe group will receive 30 minutes of myofascial release. Each intervention will be performed only on the affected limb. Nine myofascial release techniques will be applied to each group, each procedure will last 3 minutes and 20 seconds. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Study participants must be diagnosed with PF
- Age between 18 to 60 years a clinical diagnosis of unilateral PF according to the clinical practice guidelines of the orthopedic section of the American Physical Therapy Association (APTA).
- Pain intensity > 2 on the numerical pain rating scale (NPRS).
- Pain that is most intense upon awakening and decreases during walking. • Duration of pain greater than 3 months and less than 7 months.
- Both sexes.
Key exclusion criteria (3 listed)
- Who have received ankle or foot interventions within the previous three months, such as physical therapy (manual therapy, exercise, physical agents), injections, long-term history of steroid use.
- History of surgery on the ankle, foot, or inner leg.
- Other causes of heel pain: arthritic (fibromyalgia, gout, rheumatoid arthritis, seronegative spondyloarthropathies), infectious (diabetic ulcers, osteomyelitis, plantar warts), neurological (lumbar radiculopathy (L4-S2), nerve entrapment (branches of posterior tibial nerve), neuroma, tarsal tunnel syndrome, (posterior tibial nerve), trauma (calcaneal stress fracture), tumor (Ewing's sarcoma, neuroma), vascular and pregnancy.
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 |
|---|---|---|
| Myofascial releaseNine myofascial release techniques will be applied to each group: Transverse hamstring play; Transverse hamstring and adductor magnus play: posterior to anterior pressure; Transverse gastrocnemius-soleus play; Tibia bone clearing: posterior tibia; Tibia bone clearing: prone grip with half chisel; Lateral fascial distraction of the tibia; Lateral elongation of the peroneal tissue; Cross-friction of the gastrocnemius-soleus musculotendinous junction; Manipulation of the plantar fascia. | Other | Group 15 minutes, Gruops 30 minutes |
Primary outcome
Morning pain intensity measured with the Numeric Pain Rating Scale (NPRS)
Time frame: It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
The Numeric Pain Rating Scale (NPRS) measures pain intensity from 0 to 11 points (0, no pain; 10, worst pain imaginable).(18) Numeric pain scales have been shown to be reliable and valid.(25) In addition, the DCMI (minimally clinically important difference) has been reported to be 2 points.(26)
6 secondary outcomes
Pressure pain threshold (PPT)
Time frame: It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
Calf muscle stiffness (Silfverskiöl test)
Time frame: It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
Functionality (Foot Function Index (FFI))
Time frame: It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
Health-related quality of life (SF-12)
Time frame: It will be measured at Baseline, at 4 weeks and at 4 weeks after the end of the treatment
Perception of change (Patient Global Impression of Change)
Time frame: It will be measured at at 4 weeks and at 4 weeks after the end of the treatment
Foot health (Foot Health Status Questionnaire (FHSQ)
Time frame: It will be measured at Baseline, at 4 weeks and at 4 weeks after the end of the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Background: PubMed 32272106Kinney AR, Eakman AM, Graham JE. Novel Effect Size Interpretation Guidelines and an Evaluation of Statistical Power in Rehabilitation Research. Arch Phys Med Rehabil. 2020 Dec;101(12):2219-2226. doi: 10.1016/j.apmr.2020.02.017. Epub 2020 Apr 6.
- BackgroundCohen J. Statistical Power Analysis for the Behavioral Sciences: L. Erlbaum Associates; 1988.
- Background: PubMed 26604186Flight L, Julious SA. Practical guide to sample size calculations: non-inferiority and equivalence trials. Pharm Stat. 2016 Jan-Feb;15(1):80-9. doi: 10.1002/pst.1716. Epub 2015 Nov 25.
- Background: PubMed 17366962Martin RL, Irrgang JJ. A survey of self-reported outcome instruments for the foot and ankle. J Orthop Sports Phys Ther. 2007 Feb;37(2):72-84. doi: 10.2519/jospt.2007.2403.
- Background: PubMed 10025694Kamper D, Barin K, Parnianpour M, Reger S, Weed H. Preliminary investigation of the lateral postural stability of spinal cord-injured individuals subjected to dynamic perturbations. Spinal Cord. 1999 Jan;37(1):40-6. doi: 10.1038/sj.sc.3100747.
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- Individual participant dataSharing planned: Yes. The demographic characteristics and the data regarding the main variable and the secondary variables of the participants will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial release in people with Plantar Fasciitis of Both Feet, run by Universidad Católica del Maule at 1 site in Chile.
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 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: looking for participants now, as of the sponsor's last update on 27 Mar 2025. 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 Chile. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ignacio Andrés Gajardo Valenzuela, Magíster (+56993263470, igajardovalen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morning pain intensity measured with the Numeric Pain Rating Scale (NPRS) (time frame: It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment). 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 NCT06754982, which also lists 40 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 27 Mar 2025.