Investigation of the Efficacy of Myofascial Chain Release Techniques on Plantar Fasciitis

NCT05479500 | Unknown

• 1 other identifier: 2022/0346
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Plantar Fascitis

Keywords

Plantar Fascitis; Fascia; Myofascial Release Techniques

Outcome Measures

Primary Outcomes (19)

• 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.

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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.

  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.

  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.

  Change from baseline lower extremity functionality at week 6.

Study Arms (3)

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.

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.

Other: Myofascial Chain Release Techniques

Interventions

Myofascial Chain Release Techniques OTHER

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.

Group 3

Local Release Techniques OTHER

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.

Group 2

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, 34862, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 33153452 BACKGROUND

• Williams 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.

  PMID: 30860410 BACKGROUND

• Burk 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.

  PMID: 31629335 BACKGROUND

• Arshad 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.

  PMID: 34766860 BACKGROUND

• Hoefnagels 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.

  PMID: 32773360 BACKGROUND

• Martinez-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.

  PMID: 33992297 BACKGROUND

• Dhiman 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.

  PMID: 34776177 BACKGROUND

• Fauris 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.

  PMID: 34886078 BACKGROUND

Study Officials

• Nilüfer Kablan, Asst. Prof.

  Istanbul Medeniyet University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayça Evkaya Acar, MSc

CONTACT

(0216) 280 33 33; ayca.evkaya@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be divided into three groups using block randomization method. Participants will be randomly allocated into 3 blocks of 12 participants in each group using a random number generation technique by computer. All assessments will be done by researcher who were not in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 29, 2022
• Study Start: September 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)