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CTRI Number  CTRI/2024/07/070263 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 05/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Which works better for plantar fasciitis: muscles training or stretching 
Scientific Title of Study   Efficacy of muscles training versus stretching in plantar fascitis management-A comparative study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pandhare Pratiksha Shanthkumar 
Designation  Postgraduate student 
Affiliation  SDM College of physiotherapy 
Address  OPD NO 5, Ortho physiotherapy Department SDM college of Physiotherapy, SDM college of Medical Sciences and Hospital Manjushree Nagar Dharwad KARNATAKA 580009 India

Dharwad
KARNATAKA
580009
India 
Phone  9663805575  
Fax    
Email  pratikshapandhare321@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pandhare Pratiksha Shanthkumar 
Designation  Postgraduate student 
Affiliation  SDM College of physiotherapy 
Address  OPD NO 5, Ortho physiotherapy Department SDM college of Physiotherapy, SDM college of Medical Sciences and Hospital Manjushree Nagar Dharwad KARNATAKA 580009 India

Dharwad
KARNATAKA
580009
India 
Phone  9663805575  
Fax    
Email  pratikshapandhare321@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajeev Kumar Lal 
Designation  vice Principal, Professor and PG Guide, SDM college of physiotherapy 
Affiliation  SDM College of Physiotherapy 
Address  OPD NO 5, Ortho physiotherapy Department SDM college of Physiotherapy, SDM college of Medical Sciences and Hospital Manjushree Nagar Dharwad KARNATAKA 580009 India

Dharwad
KARNATAKA
580009
India 
Phone  9986202056  
Fax    
Email  lalrk@yahoo.com  
 
Source of Monetary or Material Support  
SDM College of medical sciences and hospital SDM college of Physiotherapy Manjushree Nagar sattur Dharwad 580009 karnataka India 
 
Primary Sponsor  
Name  Pandhare Pratiksha Shanthkumar 
Address  SDM college of medical sciences and hospital SDM college of Physiotherapy Manjushree nagar Sattur Dharwad 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Pandhare Pratiksha Shanthkumar  Shri Dharmasthala Manjunatheshwara college of medical sciences and hospital dharwad  Ortho Physiotherapy Department OPD number 5 Manjushree Nagar Sattur Dharwad karnataka
Dharwad
KARNATAKA 		 9663805575

pratikshapandhare321@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SDM college of medical sciences and hospital Dharwad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A is receiving stretching of plantar fascia and gastro-soleus with ultrasound.  To stretch plantar fascia subject will be in sitting position with one hand he stabilizes heel and with other hand asked to pull back the toes towards shin until stretch is felt. To stretch gastro-soleus subject will be in standing position asked to face wall with hands against at shoulder level participant stride forward with one foot keeping heel of back foot flat. 3 repeitions with 30seconds to 1 minute hold twice daily for 6 weeks.  
Intervention  Group B is receiving training of hip abductors, soleus and plantar fascia with ultrasound.  To perform intrinsic foot muscles Sit with the affected foot flat, knee bent at 90 degrees, and a napkin under the toes. Curl the toes to gather the napkin for 1-2 minutes, three times daily for 6 weeks, adding weight as needed for progression. For seated calf raises, sit with feet flat, knees bent at 100 degrees, and feet in slight dorsiflexion. Lift and lower heels for 50 reps, 3 sets, 3 times daily for 6 weeks, adding weight on thighs for progression. For hip abductor training, lie on the unaffected side with body straight and bottom knee bent for stability. Lift the top leg to a comfortable height, lower it gradually, and perform 5 reps per side (or 5 on one side with 30-second rests), twice per session, 3 times daily for 6 weeks, adding ankle weights for progression.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Unilateral/ Bilateral involvement.
2.Subjects with PF diagnosed by medical practitioners.
3.Age range from 20 to 60 years.35
4.Pain in the heel on the first step in the morning.
5.Pain with tenderness on palpation of the medial calcaneal tubercle
 
 
ExclusionCriteria 
Details  1.Individuals not willing to participate.
2.Any deformity in the affected lower limb.
3.Earlier episodes of PF treated surgically/ corticosteroids injections at heel.
4.Any fracture in the affected lower limbs within past 6 months.
5.Patients who has/had neurological problems affecting the involved lower limb.
6.Pregnant women.
7.Having undergone physiotherapy intervention for affected lower limb in the previous six months
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual analog scale (VAS)
Foot Function Index (FFI) 		 at 0 day 3rd week and 6th week 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The feet are essential support to the body in weight transmission, balance, posture maintenance and gait. They are responsible for the autonomy, independence and wellbeing of the individual. Foot posture and function are closely linked to the development of specific foot disorders. Currently, there is an increase in the prevalence of foot pathologies, ranging between 61 and 79%, which is why they constitute an important public health problem.1,2

Feet is the complex anatomical structure, understanding the foot and ankle conditions is important, as these conditions can significantly impact patients quality of life and mobility.3 Foot impairments, such as pain and weakness, are associated with functional limitations and disability, particularly in older adults.4

Heel pain is a common presenting symptom and has an extensive differential diagnosis such as plantar heel pain includes plantar fasciitis/fasciosis, Heel spur, Calcaneal stress fracture. Posteriorly includes Achilles tendinopathy, Retrocalcaneal bursitis, Haglaund deformity. Midfoot(medial) includes posterior tibialis tendinopathy, Tarsal tunnel syndrome, Flexor digitorum longus tendinopathy, Flexor hallucis longus tendinopathy. Midfoot(lateral) includes Peroneal tendinopathy, Sinus tarsi syndrome.5  Plantar fasciitis (PF) is recognized as the most common cause of heel pain, contributing significantly to foot pain cases.6

PF is also known as plantar fasciopathy, is a painful heel condition caused by inflammation of the plantar fascia aponeurosis at its origin on the calcaneous7 and normally occurs during the first few steps in the morning or after a prolonged non-weight bearing activity. The condition presents  as  sharp  pain  in  the heel that extends  from the medial border of the plantar fascia at the medial  tuberosity  of  the  calcaneus.8 The condition is associated with degeneration of the plantar fascia, often exacerbated by factors such as obesity, over-pronation of the foot, overuse injuries9 and by repetitive trauma, excessive stretching, which can result in inflammation and tears in the plantar fascia.10

PF is prevalent in the United States, with millions experiencing heel pain annually. PF occurs in about 10% of the general population, with 83% of these patients being active working adults between 25 and 65 years. The peak incidence is among the general population of 40 to 60 years.  11% to 15% of all foot symptoms requiring professional medical care. This condition accounts for about 10% of runner-related injuries. A higher prevalence of PF was observed in women compared to men.11

Risk factors for developing PF can be divided into anatomical, biomechanical, and environmental. Anatomical factor includes Pes planus, Pes cavus, Obesity, Fat pad atrophy, Shortened Achilles tendon. Biomechanical factors are Equinus, weak plantar flexor muscles, weak intrinsic muscles of foot, Excessive subtalar joint pronation, limited ankle dorsiflexion   and Environmental risk factor are trauma, hard surfaces, walking barefoot etc12.  

Diagnosis of PF can be made through the patient history, clinical symptoms, foot questionnaires, and objective assessments such as pain level, palpation, muscle tightness, joint range of motion, or muscle strength. In addition, diagnostic imaging may be used to exclude other causes of pain such as heel spurs or tissue inflammation.13 Ultrasonography may be diagnostically useful but routinely it is not used. Here the thickness of the plantar fascia will be increased.14

Early recognition and management of PF leads to short course of treatment and greater chance of success with conservative therapies. Generally, these patients start with non-surgical or conservative treatment. If this treatment cannot improve the symptoms after 6–12 months, surgical treatment will be considered.13  Numerous interventions have been described for treatment of  PF, which include: Oral analgesia,  non-steroidal anti-inflammatory drugs (NSAIDS), rest, heat, ice pack, heel pads, magnetic insole, night splints, walking cast, steroid injection, platelet-rich plasma injection, and surgery.15

The physiotherapy treatment techniques for PF include passive joint manipulation of the ankle and foot; myofascial manuevers of the gastrocnemius, soleus muscles, and plantar fascia; neural mobilization of the tibial nerve, stretching of plantar fascia and triceps surae; strengthening of hip abductors and external rotators. Electrotherapy modalities like cryotherapy, ultrasound, laser and kinesio taping are found to be effective in reducing plantar heel pain.16

Ultrasound (US) is the Electrotherapy modality used in treating pain in PF. US is a high frequency sound wave with an affinity for tendons and ligaments (highly organized, without high water content). US enhances to increase chemical activity in tissues, increase cell membrane permeability, deform molecular structures, and alter diffusion and protein synthesis rates, all potentially affecting the speed of tissue repair.17 A study conducted by Hana Hronkova on PF in which group received US for PF showed significant reduction in pain18,19. Another study conducted by Nipapron Konjen MD et al in 2015, concluded that in chronic PF treatment both rESWT and US groups found to be effective in reducing pain and increasing mobility.36

 

Even though PF has several risk factors, an abnormal biomechanical structure is considered to play an important role. Abnormalities include tightness in the Achilles tendon and plantar fascia and reduced foot and ankle muscle strength.21 Patients with  PF often also have myofascial restrictions and muscle stiffness or tightness in the gastro-soleus complex and plantar fascia.22,23 Among several conservative treatments, plantar fascia–specific and gastrocnemius/soleus stretching have shown to have moderate treatment effects which provide short-term (1 week to 4 months) pain relief for individu­als with heel pain/ PF. They are often used in the treatment programs for the patients with PF.24,25 In 2006, Digiovanni et al.26 reported that specific stretches of the plantar fascia for 8 weeks had the long-term benefit of reducing pain and function limitations, with high rate of patient satisfaction. A more recent sys­tematic review by Sweeting and colleagues concluded that the main pain-relieving benefits of stretching appear to occur within the first 2 weeks to 4 months, but could not support one method of stretching over another as being more effec­tive for reducing pain or improving function27.

On the other hand, strengthening exercises focus on enhancing the strength of the foot and lower leg muscles, which can help support the arch of the foot and reduce strain on the plantar fascia (Barredo et al., 2007).28

Reduced strength of the plantar flexors, toe flexors and abductor hallucis muscles as well as a reduction in muscle volume in the forefoot are reported to contribute to  PF.35 In 2015, Sullivan et al29 identified musculoskeletal factors in patients with PF compared to normal healthy people, and they found weakness in various muscles such as ankle evertors (peroneus brevis and longus) and toe flexors (flexor hallucis longus and brevis, flexor digitorum longus and brevis).29 In addition, weakness of the tibialis posterior muscle was also reported in previous studies.25,30

Weakness of the intrinsic and extrinsic muscles of the foot may result in the recurrent symptoms of PF due to improper functioning of the muscle and joint positioning during walking.20,25,29  Results of the univariate analysis showed that the following factors predicted a higher rate of  PF: being 40 to 55 years old; being 56 to 65 years old; having weakness of the gastrocnemius, soleus, and intrinsic foot muscles31. Weakness and tightness of the gastrocnemius soleus and the intrinsic foot muscles were found in 0.9% of the participants. Similar findings were reported in the study conducted by Huerta et al., in which tightness of the gastrocnemius muscle was found to be linked with PF in most of the participants31. According to a 2014 study by Rathleff et al., daily heel-raising activities are more helpful than plantar-specific stretching after three months. At 1, 2, 6, or 12 months following this intervention, however, these exercises did not demonstrate any difference in foot function13.

Research has shown that a combination of stretching and strengthening exercises can be effective in managing  PF. Studies have compared different physiotherapy methods, including calf stretching and plantar fascia-specific stretching, and have found positive outcomes in terms of pain reduction and improved function (Ersen et al., 2017)

The closed kinetic chain theory suggests that proximal core hip strength is needed for control of distal segments to prevent injury. If one joint of the lower extremity is not functioning properly, injuries can be manifested in other joints or structures, particularly those that are distal to the affected joint.  So hip muscles weakness may play a role in knee and ankle overuse injuries. Studies identifying various diagnoses and treatment findings in injured runners experiencing anterior knee pain,  Achilles tendinosis,  PF and stress fractures have focused examination findings and biomechanical risk factors directly on or distal to the site of pain but have not included proximal risk factors such as hip weakness. Recent studies have reported that foot postures such as apparent low-arch foot (pronated) and high-arch foot (supinated) were associated with weakness of the hip abductor muscles, since the hip muscles play an important role in lower limb biomechanics. Increased compensatory mechanisms of the ankle joint caused by weakness of the hip abductor muscles may have caused the intractable heel pain. Weakness of the hip abductor muscles during walking may result in plantar flexion muscle overuse, which can increase the load on the plantar fascia.33,34

The exercise regimens mentioned earlier play a role in promoting PF recovery by enhancing muscle strength and alleviating muscle tightness. However, due to a scarcity of comparative studies evaluating the efficacy of muscles training versus stretching exercises, it remains unclear which type of exercise yields greater improvement in PF symptoms. Therefore, this study aimed to investigate the effects of muscles training and stretching exercise programs combined with a physical therapy intervention on pain intensity, disability and activity restriction in patients with PF. 
 
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