Plantar FascitisNCT05479500
Investigation of the Efficacy of Myofascial Chain Release Techniques on Plantar Fasciitis
A study testing Myofascial Chain Release Techniques and Local Release Techniques in people with Plantar Fascitis, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of the study is to investigate the effectiveness of Myofascial Chain Release Techniques on pain, functional limitation and quality of life in patients with Plantar Fasciitis. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Myofascial Chain Release Techniques and Local Release Techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Sep 2023
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Volunteers between the ages of 30-60
- Diagnosed with plantar fasciitis
- Not having received medical treatment and/or physiotherapy for plantar fasciitis in the last 3 months.
- The participants' definition of pain over 3 according to the Visual Analogue Scale in the first step of the morning and this pain decreases with movements
Who cannot join
- Having history of lower extremity surgery and fracture in the last 6 months
- Having additional orthopedic, neurological and rheumatological diseases that may cause biomechanical malalignment, loss of muscle strength, and deterioration of gait parameters in the lower extremities, vertebral column and pelvis
- Having static foot deformity
- Having connective tissue disease that will affect tissue properties
- Having metabolic syndromes that may affect tissue properties such as diabetes
- Using sedatives and/or muscle relaxants that may alter muscle tone.
- Being diagnosed with obesity (BMI>30)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University
Istanbul, 34862
Ayça Evkaya Acar, MSc, ayca.evkaya@gmail.com
Nilüfer Kablan, Asst. Prof.
About this study
Official title: Investigation of the Efficacy of Myofascial Chain Release Techniques on Plantar Fasciitis Pain, Lower Extremity Functional Capacity and Quality of Life - Randomized Controlled Study
The primary aim of the study is to investigate the effectiveness of Myofascial Chain Release Techniques on pain, functional limitation and quality of life in patients with Plantar Fasciitis. The secondary aim of the study is to create a future clinical projection regarding the applications to be made over the myofascial chain in addition to the generally accepted treatment protocols in the light of the findings.
There will be three groups in this study. Each group will consist of 12 patients aged 30-60 years with plantar fasciitis. A total of 36 participants will take part in the study. Conventional physiotherapy will be applied to the group 1 and, local release technique addition to conventional physiotherapy will be applied to the group 2, while myofascial release techniques will be applied to the experimental group in addition to conventional physiotherapy. Treatment programs will be applied to both groups 2 days a week for 6 weeks. Postural problems that can be seen in the superficial back myofascial chain line will be evaluated.
Read the detailed description
The plantar fascia is an important connective structure that extends from the metatarsal heads to the calcaneus and provides the continuity of the longitudinal arch of the foot. Microtraumas and the formation of chronic inflammation on the plantar surface, which is exposed to repetitive stress, thickens the fascia, making it susceptible to repetitive injuries and forming plantar fasciitis. The reasons for this repetitive stress are; excessive physical activity, obesity, age, prolonged standing, biomechanical changes, limited dorsiflexion and hamstring tension.
Studies on this subject in the literature have reported that tension in the hind leg muscles is associated with plantar fasciitis, and applications on the Achilles tendon and gastrocnemius have been shown to relieve plantar fasciitis complaints. Similarly, it has been reported that tension in the hamstring muscle may be associated with the development of plantar fasciitis.
It is known that the Plantar Fascia and Achilles tendon affect each other due to the fascial connection, and therefore these structures are considered together in the solution of their problems. On the other hand, according to the fascial meridian concept developed by Thomas Myers, it was stated that the fascial connection between these two tissues extends to the frontal region in a chain manner, and that a problem at any point in the chain may cause problems in other elements of the chain. For this reason, recently, applications related to the detection and solution of problems have come to the fore by looking at fascial problems more holistically over the fascial chain. From this point of view, there are many studies reporting the effectiveness of applications performed in any region of the myofascial chain in a different region on this chain.
Plantar Fascia; It is located in the Superficial Back Line, and as far as we know, there is no study of plantar fasciitis treatment in which the myofascial chain is considered as a whole. Based on this, our aim in this study is to investigate the effect of myofascial release techniques applied along the myofascial chain line on pain, lower extremity functionality and quality of life in patients diagnosed with Plantar fasciitis. In the light of the findings, it is to create a projection for future clinical studies regarding the treatment approaches to be applied over the myofascial chain in addition to the generally accepted treatment protocols.
- Conditions
- Plantar Fascitis
- Being tested
- Myofascial Chain Release Techniques, Local Release Techniques
- Keywords
- Plantar Fascitis, Fascia, Myofascial Release Techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial Chain Release TechniquesOther
Myofascial release is a hands on technique which stretches the fascia and releases, bonds between muscles, integuments and fascia in order to eliminate pain, improve motion and to maintain myofascial balance within the body.
Local Release TechniquesOther
Local Release Techniques are a soft tissue method that focuses on relieving tissue tension via the removal of fibrosis/adhesions which can develop in tissues as a result of overload due to repetitive use.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Control group will consist of 12 patients with diagnosed Plantar Fasciitis, aged between 30-60 years. Only conventional physiotherapy program will be applied to this group. Conventional treatment will consist of foot intrinsic muscles strengthening, plantar fascia, achilles and hamstring stretching exercises. The exercises will be performed as 10 repetitions and 3 sets. Participants will be treated for a total of 6 weeks, 2 days a week. Each treatment session will last 20-40 minutes. |
| Group 2 | Experimental | Experimental group will consist of 12 patients with diagnosed Plantar Fasciitis, aged between 30-60 years. In addition to the conventional physiotherapy program, local release techniques will be applied to this group. Local Release Techniques will be applied as Gastro-solues trigger point myofascial release and Plantar fascia myofascial release. Participants will be treated for a total of 6 weeks, 2 days a week. Each treatment session will last 20-40 minutes. Receives: Other: Local Release Techniques |
| Group 3 | Experimental | Experimental group will consist of 12 patients with diagnosed Plantar Fasciitis, aged between 30-60 years. In addition to the conventional physiotherapy program, myofascial chain release techniques will be applied to this group.
Myofascial release technique will be applied to the center of coordination points in the superficial back line myofascial chain of the body. Pressure will be applied to each point with 6 repetitions and lasting approximately 5-6 seconds.
Participants will be treated for a total of 6 weeks, 2 days a week. Each treatment session will last 20-40 minutes. Receives: Other: Myofascial Chain Release Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography
It will be used to measure the thickness of the plantar fascia. As a result of these studies, a plantar fascia greater than 4 mm appears to be abnormal and associated with plantar fasciitis. Ultrasonography (USG) evaluation is a routine method for the diagnosis of Plantar Fasciitis.
Measured: Change from baseline ultrasonography at week 6.
Plantar Fasciitis Pain
Visual Analogue Scale will be used in the assessment of pain severity. It expresses pain severity between a score of 0 (no pain) and 10 (unbearably severe pain).
Measured: Change from baseline plantar fasciitis pain at week 6.
Pes planus
Pes Planus will be evaluated with navicular drop test. The distance between the navicular bone and the ground is measured while the individual sits on the chair with the hip-knee joint in 90º flexion and the subtalar joint in neutral position. Then, the distance between the navicular bone and the ground is measured again while the individual is standing in a position with equal weight on both extremities. The difference between the two measurements is recorded. 10 mm or more difference is considered pes planus.
Measured: Change from baseline pes planus at week 6.
Foot Posture
Foot posture will be evaluated using the Foot posture index, a six item foot posture assessment tool, where each item is scored between -2 and +2 to give a sum total between -12 (highly supinated) and +12 (highly pronated). Items include: talar head palpation, curves above and below the lateral malleoli, calcaneal angle, talonavicular bulge, medial longitudinal arch, and forefoot to rearfoot alignment.
Measured: Change from baseline foot posture at week 6.
Ankle Joint Angle
Active and passive dorsi and plantar flexion angles will be measured with a goniometer.
Measured: Change from baseline ankle joint angles at week 6.
Algometer
It is used to measure the pressure pain threshold. After localization of the painful area by palpation, force is applied with an algometer until patients feel pain and discomfort. The digit displayed on the algometer is recorded. The average of 3 measurements is taken.
Measured: Change from baseline pressure pain threshold at week 6.
Passive Tone
Passive Tone will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.
Measured: Change from baseline passive tone of myofascial tissues at week 6.
Stiffness
Stiffness will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.
Measured: Change from baseline Stiffness of myofascial tissues at week 6.
Decrement
Decrement will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.
Measured: Change from baseline Decrement of myofascial tissues at week 6.
Creep
Creep will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.
Measured: Change from baseline Creep of myofascial tissues at week 6.
Relaxation time
Relaxation time will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.
Measured: Change from baseline Relaxation time of myofascial tissues at week 6.
Hamstring Muscle shortness
Hamstring length will be measured with the straight leg lift test. The patient is asked to keep the opposite leg fixed on the bed with the knee straight in the supine position, wearing suitable clothes, and to raise the leg to be tested upwards with the ankle in dorsiflexion and the knee straight. The patient is instructed to wait where the initial tension occurs, and the last degree of movement is measured.
Measured: Change from baseline Hamstring muscle shortness at week 6.
Pelvic tilt
The position of the pelvis will be evaluated with a digital pelvic inclinometer device to determine whether the pelvis has tilted anteriorly or posteriorly. The digital pelvic inclinometer is a valid and reliable method for the evaluation of pelvic tilt. The device consists of two calipers and the calipers are placed on the spina iliaca anterior superior (SIAS) and spina iliaca posterior superior (SIPS) of the pelvis. The score on the digital display is recorded. "-" values indicate posterior pelvic tilt, "+" values indicate anterior pelvic tilt.
Measured: Change from baseline pelvic tilt at week 6.
Cervical and Lumbar Lordosis
It will be determined by photographing. Side photos will be taken while the patient is standing in a free standing position in front of a bare, flat wall with the upper body. Later, the obtained photo shoots will be analyzed with the Tracker 4.11.0 (Physlets, 2017) program and cervical and lumbar lordosis angles will be determined.
Measured: Change from baseline Cervical and Lumbar Lordosis at week 6.
Skin temperature of the Plantar Fascitis area
In order to see the effectiveness of the applications, the skin temperature will be determined by thermal imaging method. This method is frequently preferred because it is a reliable and non-invasive method. The skin temperature of the plantar fascia will be measured with the P45 thermographic camera (Flir System, ThermaCAM, Sweden) with high thermal sensitivity, while the patient is in the prone position, while the feet are hanging from the bed at the level of the malleolus. The measurement will be made by placing the camera on a tripod placed 1m away from the patient. In the analysis, the area covering 1 cm distance from the point where fasciitis develops will be used. Skin temperature will be determined using the FLIR Quick-Report 1.2 software, one of the temperature indicators obtained from this region. In the calculation of skin temperature, the human skin emissivity value will be accepted as 0.98.
Measured: Change from baseline Skin temperature of the Plantar Fascitis area at week 6.
Headache
Presence of headache will be questioned and severity assessment will be made with Visual Analogue Scale. It expresses pain severity between a score of 0 (no pain) and 10 (unbearably severe pain).
Measured: Change from baseline Headache at week 6.
Windlass Test
While the patient is sitting in a chair, the big toe of the foot to be tested is brought into the dorsal flexion of the metatarsal phalangeal joint for a hard time. Pain at the junction of the plantar fascia with the calcaneus during this movement indicates a positive test.
Measured: Change from baseline Windlass Test at week 6.
SF-12 Quality of Life
An abbreviated form for assessing quality of life. SF-12, a form developed in 1994, is not specific to any age and disease type, and is a scale that evaluates the quality of life of the person during the last four weeks. SF-12; physical functionality includes physical role, pain, general health, emotional role, mental health, social functionality and vitality.
Measured: Change from baseline Quality of Life at week 6.
Lower extremity functionality
Lower extremity functional scale will be used. This scale is a valid and reliable scale used in musculoskeletal problems affecting the lower extremities. It consists of 20 items. Each item is scored between 0-4. The total score is between 0-80. Higher scores indicate better functional status.
Measured: Change from baseline lower extremity functionality at week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Model description
- There will be three groups in this study. Each group will consist of 12 patients aged 30-60 years with plantar fasciitis. A total of 36 participants will take part in the study. Conventional physiotherapy will be applied to the group 1 and, local release technique addition to conventional physiotherapy will be applied to the group 2, while myofascial release techniques will be applied to the experimental group in addition to conventional physiotherapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Evkaya Acar, Istanbul Medeniyet University
- Investigators
- Nilüfer Kablan, Asst. Prof., Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479500
- Sponsor's protocol ID
- 2022/0346
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JH, Jung HW, Jang WY. A prospective study of the muscle strength and reaction time of the quadriceps, hamstring, and gastrocnemius muscles in patients with plantar fasciitis. BMC Musculoskelet Disord. 2020 Nov 5;21(1):722. doi: 10.1186/s12891-020-03740-1.
PubMed 33153452Williams W, Selkow NM. Self-Myofascial Release of the Superficial Back Line Improves Sit-and-Reach Distance. J Sport Rehabil. 2019 Oct 18;29(4):400-404. doi: 10.1123/jsr.2018-0306. Print 2020 May 1.
PubMed 30860410Burk C, Perry J, Lis S, Dischiavi S, Bleakley C. Can Myofascial Interventions Have a Remote Effect on ROM? A Systematic Review and Meta-Analysis. J Sport Rehabil. 2019 Oct 18;29(5):650-656. doi: 10.1123/jsr.2019-0074. Print 2020 Jul 1.
PubMed 31629335Arshad Z, Aslam A, Razzaq MA, Bhatia M. Gastrocnemius Release in the Management of Chronic Plantar Fasciitis: A Systematic Review. Foot Ankle Int. 2022 Apr;43(4):568-575. doi: 10.1177/10711007211052290. Epub 2021 Nov 12.
PubMed 34766860Hoefnagels EM, Weerheijm L, Witteveen AG, Louwerens JK, Keijsers N. The effect of lengthening the gastrocnemius muscle in chronic therapy resistant plantar fasciitis. Foot Ankle Surg. 2021 Jul;27(5):543-549. doi: 10.1016/j.fas.2020.07.003. Epub 2020 Jul 12.
PubMed 32773360Martinez-Lema D, Guede-Rojas F, Gonzalez-Fernandez K, Soto-Martinez A, Lagos-Hausheer L, Vergara-Rios C, Marquez-Mayorga H, Mancilla CS. Immediate effects of a direct myofascial release technique on hip and cervical flexibility in inactive females with hamstring shortening: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:57-63. doi: 10.1016/j.jbmt.2020.12.013. Epub 2020 Dec 11.
PubMed 33992297Dhiman NR, Das B, Mohanty C, Singh OP, Gyanpuri V, Raj D. Myofascial release versus other soft tissue release techniques along superficial back line structures for improving flexibility in asymptomatic adults: A systematic review with meta-analysis. J Bodyw Mov Ther. 2021 Oct;28:450-457. doi: 10.1016/j.jbmt.2021.06.026. Epub 2021 Jun 16.
PubMed 34776177Fauris P, Lopez-de-Celis C, Canet-Vintro M, Martin JC, Llurda-Almuzara L, Rodriguez-Sanz J, Labata-Lezaun N, Simon M, Perez-Bellmunt A. Does Self-Myofascial Release Cause a Remote Hamstring Stretching Effect Based on Myofascial Chains? A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Nov 24;18(23):12356. doi: 10.3390/ijerph182312356.
PubMed 34886078
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacy of Myofascial Chain Release Techniques on Plantar Fasciitis Pain, Lower Extremity Functional Capacity and Quality of Life - Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05479500
- Acronym / sponsor ID
- 2022/0346
- Conditions
- Plantar Fascitis
- Keywords
- Plantar Fascitis, Fascia, Myofascial Release Techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 29 Jul 2022 (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.
The primary aim of the study is to investigate the effectiveness of Myofascial Chain Release Techniques on pain, functional limitation and quality of life in patients with Plantar Fasciitis. The secondary aim of the study is to create a future clinical projection regarding the applications to be made over the myofascial chain in addition to the generally accepted treatment protocols in the light of the findings.
There will be three groups in this study. Each group will consist of 12 patients aged 30-60 years with plantar fasciitis. A total of 36 participants will take part in the study. Conventional physiotherapy will be applied to the group 1 and, local release technique addition to conventional physiotherapy will be applied to the group 2, while myofascial release techniques will be applied to the experimental group in addition to conventional physiotherapy. Treatment programs will be applied to both groups 2 days a week for 6 weeks. Postural problems that can be seen in the superficial back myofascial chain line will be evaluated.
Detailed description
The plantar fascia is an important connective structure that extends from the metatarsal heads to the calcaneus and provides the continuity of the longitudinal arch of the foot. Microtraumas and the formation of chronic inflammation on the plantar surface, which is exposed to repetitive stress, thickens the fascia, making it susceptible to repetitive injuries and forming plantar fasciitis. The reasons for this repetitive stress are; excessive physical activity, obesity, age, prolonged standing, biomechanical changes, limited dorsiflexion and hamstring tension.
Studies on this subject in the literature have reported that tension in the hind leg muscles is associated with plantar fasciitis, and applications on the Achilles tendon and gastrocnemius have been shown to relieve plantar fasciitis complaints. Similarly, it has been reported that tension in the hamstring muscle may be associated with the development of plantar fasciitis.
It is known that the Plantar Fascia and Achilles tendon affect each other due to the fascial connection, and therefore these structures are considered together in the solution of their problems. On the other hand, according to the fascial meridian concept developed by Thomas Myers, it was stated that the fascial connection between these two tissues extends to the frontal region in a chain manner, and that a problem at any point in the chain may cause problems in other elements of the chain. For this reason, recently, applications related to the detection and solution of problems have come to the fore by looking at fascial problems more holistically over the fascial chain. From this point of view, there are many studies reporting the effectiveness of applications performed in any region of the myofascial chain in a different region on this chain.
Plantar Fascia; It is located in the Superficial Back Line, and as far as we know, there is no study of plantar fasciitis treatment in which the myofascial chain is considered as a whole. Based on this, our aim in this study is to investigate the effect of myofascial release techniques applied along the myofascial chain line on pain, lower extremity functionality and quality of life in patients diagnosed with Plantar fasciitis. In the light of the findings, it is to create a projection for future clinical studies regarding the treatment approaches to be applied over the myofascial chain in addition to the generally accepted treatment protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- There will be three groups in this study. Each group will consist of 12 patients aged 30-60 years with plantar fasciitis. A total of 36 participants will take part in the study. Conventional physiotherapy will be applied to the group 1 and, local release technique addition to conventional physiotherapy will be applied to the group 2, while myofascial release techniques will be applied to the experimental group in addition to conventional physiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Control group will consist of 12 patients with diagnosed Plantar Fasciitis, aged between 30-60 years. Only conventional physiotherapy program will be applied to this group. Conventional treatment will consist of foot intrinsic muscles strengthening, plantar fascia, achilles and hamstring stretching exercises. The exercises will be performed as 10 repetitions and 3 sets. Participants will be treated for a total of 6 weeks, 2 days a week. Each treatment session will last 20-40 minutes. |
| Group 2 | Experimental | Other: Local Release TechniquesExperimental group will consist of 12 patients with diagnosed Plantar Fasciitis, aged between 30-60 years. In addition to the conventional physiotherapy program, local release techniques will be applied to this group. Local Release Techniques will be applied as Gastro-solues trigger point myofascial release and Plantar fascia myofascial release. Participants will be treated for a total of 6 weeks, 2 days a week. Each treatment session will last 20-40 minutes. |
| Group 3 | Experimental | Other: Myofascial Chain Release TechniquesExperimental group will consist of 12 patients with diagnosed Plantar Fasciitis, aged between 30-60 years. In addition to the conventional physiotherapy program, myofascial chain release techniques will be applied to this group. Myofascial release technique will be applied to the center of coordination points in the superficial back line myofascial chain of the body. Pressure will be applied to each point with 6 repetitions and lasting approximately 5-6 seconds. Participants will be treated for a total of 6 weeks, 2 days a week. Each treatment session will last 20-40 minutes. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Volunteers between the ages of 30-60
- Diagnosed with plantar fasciitis
- Not having received medical treatment and/or physiotherapy for plantar fasciitis in the last 3 months.
- The participants' definition of pain over 3 according to the Visual Analogue Scale in the first step of the morning and this pain decreases with movements
Key exclusion criteria (8 listed)
- Having history of lower extremity surgery and fracture in the last 6 months
- Having additional orthopedic, neurological and rheumatological diseases that may cause biomechanical malalignment, loss of muscle strength, and deterioration of gait parameters in the lower extremities, vertebral column and pelvis
- Having static foot deformity
- Having connective tissue disease that will affect tissue properties
- Having metabolic syndromes that may affect tissue properties such as diabetes
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 Chain Release TechniquesMyofascial release is a hands on technique which stretches the fascia and releases, bonds between muscles, integuments and fascia in order to eliminate pain, improve motion and to maintain myofascial balance within the body. | Other | Group 3 |
| Local Release TechniquesLocal Release Techniques are a soft tissue method that focuses on relieving tissue tension via the removal of fibrosis/adhesions which can develop in tissues as a result of overload due to repetitive use. | Other | Group 2 |
Primary outcome
Ultrasonography
Time frame: Change from baseline ultrasonography at week 6.
It will be used to measure the thickness of the plantar fascia. As a result of these studies, a plantar fascia greater than 4 mm appears to be abnormal and associated with plantar fasciitis. Ultrasonography (USG) evaluation is a routine method for the diagnosis of Plantar Fasciitis.
Plantar Fasciitis Pain
Time frame: Change from baseline plantar fasciitis pain at week 6.
Visual Analogue Scale will be used in the assessment of pain severity. It expresses pain severity between a score of 0 (no pain) and 10 (unbearably severe pain).
Pes planus
Time frame: Change from baseline pes planus at week 6.
Pes Planus will be evaluated with navicular drop test. The distance between the navicular bone and the ground is measured while the individual sits on the chair with the hip-knee joint in 90º flexion and the subtalar joint in neutral position. Then, the distance between the navicular bone and the ground is measured again while the individual is standing in a position with equal weight on both extremities. The difference between the two measurements is recorded. 10 mm or more difference is considered pes planus.
Foot Posture
Time frame: Change from baseline foot posture at week 6.
Foot posture will be evaluated using the Foot posture index, a six item foot posture assessment tool, where each item is scored between -2 and +2 to give a sum total between -12 (highly supinated) and +12 (highly pronated). Items include: talar head palpation, curves above and below the lateral malleoli, calcaneal angle, talonavicular bulge, medial longitudinal arch, and forefoot to rearfoot alignment.
Ankle Joint Angle
Time frame: Change from baseline ankle joint angles at week 6.
Active and passive dorsi and plantar flexion angles will be measured with a goniometer.
Algometer
Time frame: Change from baseline pressure pain threshold at week 6.
It is used to measure the pressure pain threshold. After localization of the painful area by palpation, force is applied with an algometer until patients feel pain and discomfort. The digit displayed on the algometer is recorded. The average of 3 measurements is taken.
Passive Tone
Time frame: Change from baseline passive tone of myofascial tissues at week 6.
Passive Tone will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.
Stiffness
Time frame: Change from baseline Stiffness of myofascial tissues at week 6.
Stiffness will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.
Decrement
Time frame: Change from baseline Decrement of myofascial tissues at week 6.
Decrement will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.
Creep
Time frame: Change from baseline Creep of myofascial tissues at week 6.
Creep will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.
Relaxation time
Time frame: Change from baseline Relaxation time of myofascial tissues at week 6.
Relaxation time will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.
Hamstring Muscle shortness
Time frame: Change from baseline Hamstring muscle shortness at week 6.
Hamstring length will be measured with the straight leg lift test. The patient is asked to keep the opposite leg fixed on the bed with the knee straight in the supine position, wearing suitable clothes, and to raise the leg to be tested upwards with the ankle in dorsiflexion and the knee straight. The patient is instructed to wait where the initial tension occurs, and the last degree of movement is measured.
Pelvic tilt
Time frame: Change from baseline pelvic tilt at week 6.
The position of the pelvis will be evaluated with a digital pelvic inclinometer device to determine whether the pelvis has tilted anteriorly or posteriorly. The digital pelvic inclinometer is a valid and reliable method for the evaluation of pelvic tilt. The device consists of two calipers and the calipers are placed on the spina iliaca anterior superior (SIAS) and spina iliaca posterior superior (SIPS) of the pelvis. The score on the digital display is recorded. "-" values indicate posterior pelvic tilt, "+" values indicate anterior pelvic tilt.
Cervical and Lumbar Lordosis
Time frame: Change from baseline Cervical and Lumbar Lordosis at week 6.
It will be determined by photographing. Side photos will be taken while the patient is standing in a free standing position in front of a bare, flat wall with the upper body. Later, the obtained photo shoots will be analyzed with the Tracker 4.11.0 (Physlets, 2017) program and cervical and lumbar lordosis angles will be determined.
Skin temperature of the Plantar Fascitis area
Time frame: Change from baseline Skin temperature of the Plantar Fascitis area at week 6.
In order to see the effectiveness of the applications, the skin temperature will be determined by thermal imaging method. This method is frequently preferred because it is a reliable and non-invasive method. The skin temperature of the plantar fascia will be measured with the P45 thermographic camera (Flir System, ThermaCAM, Sweden) with high thermal sensitivity, while the patient is in the prone position, while the feet are hanging from the bed at the level of the malleolus. The measurement will be made by placing the camera on a tripod placed 1m away from the patient. In the analysis, the area covering 1 cm distance from the point where fasciitis develops will be used. Skin temperature will be determined using the FLIR Quick-Report 1.2 software, one of the temperature indicators obtained from this region. In the calculation of skin temperature, the human skin emissivity value will be accepted as 0.98.
Headache
Time frame: Change from baseline Headache at week 6.
Presence of headache will be questioned and severity assessment will be made with Visual Analogue Scale. It expresses pain severity between a score of 0 (no pain) and 10 (unbearably severe pain).
Windlass Test
Time frame: Change from baseline Windlass Test at week 6.
While the patient is sitting in a chair, the big toe of the foot to be tested is brought into the dorsal flexion of the metatarsal phalangeal joint for a hard time. Pain at the junction of the plantar fascia with the calcaneus during this movement indicates a positive test.
SF-12 Quality of Life
Time frame: Change from baseline Quality of Life at week 6.
An abbreviated form for assessing quality of life. SF-12, a form developed in 1994, is not specific to any age and disease type, and is a scale that evaluates the quality of life of the person during the last four weeks. SF-12; physical functionality includes physical role, pain, general health, emotional role, mental health, social functionality and vitality.
Lower extremity functionality
Time frame: Change from baseline lower extremity functionality at week 6.
Lower extremity functional scale will be used. This scale is a valid and reliable scale used in musculoskeletal problems affecting the lower extremities. It consists of 20 items. Each item is scored between 0-4. The total score is between 0-80. Higher scores indicate better functional status.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Background: PubMed 33153452Lee JH, Jung HW, Jang WY. A prospective study of the muscle strength and reaction time of the quadriceps, hamstring, and gastrocnemius muscles in patients with plantar fasciitis. BMC Musculoskelet Disord. 2020 Nov 5;21(1):722. doi: 10.1186/s12891-020-03740-1.
- Background: PubMed 30860410Williams W, Selkow NM. Self-Myofascial Release of the Superficial Back Line Improves Sit-and-Reach Distance. J Sport Rehabil. 2019 Oct 18;29(4):400-404. doi: 10.1123/jsr.2018-0306. Print 2020 May 1.
- Background: PubMed 31629335Burk C, Perry J, Lis S, Dischiavi S, Bleakley C. Can Myofascial Interventions Have a Remote Effect on ROM? A Systematic Review and Meta-Analysis. J Sport Rehabil. 2019 Oct 18;29(5):650-656. doi: 10.1123/jsr.2019-0074. Print 2020 Jul 1.
- Background: PubMed 34766860Arshad Z, Aslam A, Razzaq MA, Bhatia M. Gastrocnemius Release in the Management of Chronic Plantar Fasciitis: A Systematic Review. Foot Ankle Int. 2022 Apr;43(4):568-575. doi: 10.1177/10711007211052290. Epub 2021 Nov 12.
- Background: PubMed 32773360Hoefnagels EM, Weerheijm L, Witteveen AG, Louwerens JK, Keijsers N. The effect of lengthening the gastrocnemius muscle in chronic therapy resistant plantar fasciitis. Foot Ankle Surg. 2021 Jul;27(5):543-549. doi: 10.1016/j.fas.2020.07.003. Epub 2020 Jul 12.
- Background: PubMed 33992297Martinez-Lema D, Guede-Rojas F, Gonzalez-Fernandez K, Soto-Martinez A, Lagos-Hausheer L, Vergara-Rios C, Marquez-Mayorga H, Mancilla CS. Immediate effects of a direct myofascial release technique on hip and cervical flexibility in inactive females with hamstring shortening: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:57-63. doi: 10.1016/j.jbmt.2020.12.013. Epub 2020 Dec 11.
- Background: PubMed 34776177Dhiman NR, Das B, Mohanty C, Singh OP, Gyanpuri V, Raj D. Myofascial release versus other soft tissue release techniques along superficial back line structures for improving flexibility in asymptomatic adults: A systematic review with meta-analysis. J Bodyw Mov Ther. 2021 Oct;28:450-457. doi: 10.1016/j.jbmt.2021.06.026. Epub 2021 Jun 16.
- Background: PubMed 34886078Fauris P, Lopez-de-Celis C, Canet-Vintro M, Martin JC, Llurda-Almuzara L, Rodriguez-Sanz J, Labata-Lezaun N, Simon M, Perez-Bellmunt A. Does Self-Myofascial Release Cause a Remote Hamstring Stretching Effect Based on Myofascial Chains? A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Nov 24;18(23):12356. doi: 10.3390/ijerph182312356.
- 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.
Nilüfer Kablan, Asst. Prof. principal investigator
Istanbul Medeniyet 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 Myofascial Chain Release Techniques and Local Release Techniques in people with Plantar Fascitis, run by Istanbul Medeniyet University 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 4 inclusion and 8 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 1 Aug 2022. 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 Ayça Evkaya Acar, MSc ((0216) 280 33 33, ayca.evkaya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonography (time frame: Change from baseline ultrasonography at week 6.). The study lists 19 primary outcomes in all. 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 NCT05479500, which also lists 8 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 1 Aug 2022.