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CTRI Number  CTRI/2024/04/065988 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 16/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Comparison of Extracorporeal shockwave therapy versus Matrix rhythm therapy in individuals having plantar fasciitis. 
Scientific Title of Study   Comparison of Extracorporeal shockwave therapy versus Matrix rhythm therapy on pain, range of motion and functional recovery in individuals having chronic plantar fasciitis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
divyagohil28@gmail.com  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishna Katkar 
Designation  Post graduate student 
Affiliation  Dr. D.Y. Patil College of Physiotherapy 
Address  Dr D Y Patil College Of Physiotherapy,Third floor, Cardio respiratory Department, Sant Tukaram Nagar, Pimpri, Pune
Dr D Y Patil College Of Physiotherapy,Third floor, Cardio respiratory Department, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India 
Phone  9867374947  
Fax    
Email  katkarkrishna99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Divya Gohil 
Designation  Associate professor  
Affiliation  Dr. D.Y.Patil College Of Physiotherapy 
Address  Dr D Y Patil College Of Physiotherapy,Third floor, Cardio respiratory Department, Sant Tukaram Nagar, Pimpri, Pune
Dr D Y Patil College Of Physiotherapy,Third floor, Cardio respiratory Department,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India 
Phone  7767828290  
Fax    
Email  divyagohil28@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Divya Gohil 
Designation  Associate professor  
Affiliation  Dr. D.Y.Patil College Of Physiotherapy 
Address  Dr D Y Patil College Of Physiotherapy, Third floor,Cardiorespiratory Department, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  7767828290  
Fax    
Email  divyagohil28@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil College Of Physiotherapy 
 
Primary Sponsor  
Name  Dr D Y Patil College Of Physiotherapy 
Address  Dr D Y Patil College Of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune 411018 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Divya Gohil  Dr D Y Patil College Of Physiotherapy   OPD, Ground floor, Dr D Y Patil College Of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune 411018.
Mumbai
MAHARASHTRA 
7767828290

divyagohil28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics committee of Dr. D. Y. Patil College of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Plantar fasciitis  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Extracorporeal shockwave therapy   Four sessions of Radial-(Extracorporeal Shockwave Therapy) over two weeks. Frequency of 10.0 Hz with 2000 shocks per treatment session at a 3.0 bar pressure. Exercise protocol: i.Stretching: calf muscles (30 sec hold- 3 repetitions) plantar fascia (30 sec hold- 3 repetitions) ii.Strengthening exercises for intrinsic foot muscles: Towel toe curls (15 reps – 3 sets) Ankle invertors and evertors (10 reps – 3 sets) Heel raise (10 reps-3 sets) Total Duration is 45 Minutes  
Intervention  Matrix rhythm therapy   Four sessions of Matrix rhythm therapy for two weeks. Frequency:10Hz to 4Hz Duration :45 mins Exercise protocol: 15 mins i.Stretching : calf muscles (30 sec hold- 3 repetitions) plantar fascia (30 sec hold- 3 repetitions) ii.Strengthening exercises for intrinsic foot muscles: Towel toe curls (15 reps – 3 sets) Ankle invertors and evertors (10 reps – 3 sets) Heel raise (10 reps-3 sets) Total Duration is 60 Minutes 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The presence of ‘start-up heel pain’ ≥3 months duration,
Positive Windlass test,
Moderate pain intensity(3-7) on the Visual Analog Scale (VAS)
 
 
ExclusionCriteria 
Details  Ankle/foot fracture,
Ankle/foot infections,
Neurological deficits of the lower limb (eg. hypoesthesia, neuropathy),
Bleeding disorders,
Pes cavus/ pes planus
•Local steroid injection within the previous 3 months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Visual analog scale for pain
2) Ankle range of motion
3) Foot function index for functional recovery 
1) Baseline
2) After 2 weeks intervention
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/05/2024 
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="5"
Days="15" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Those who contact PI

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

INTRODUCTION:

Plantar fasciitis is one of the most common causes of under-surface heel pain, with a lifetime prevalence of 10%.It is a condition that is caused by biomechanical overuse resulting in degenerative changes at its attachment to the calcaneus  It most commonly affects people aged 40–60 years and affects both sedentary and active populations.

The plantar fascia is comprised of 3 bands of dense, fibrous connective tissue on the plantar aspect of the foot. It is a tendinous aponeurosis or sheet of connective tissue that incorporates the muscles on the sole of the foot .The bands originate in the medial tubercle of the calcaneus and terminate at the base of the proximal phalanges. These 3 bands (medial, central, and lateral) are the main parts of the longitudinal arch, connecting the 3 points of weight-bearing in the foot.

The pathogenesis of plantar fasciitis is like tendinosis. When there is an overload or excessive strain on the plantar facia, this produces microtears, activating the inflammatory response. Since the traumas are repeated at each step, inflammation becomes chronic, and degenerative changes occur in the plantar fascia, especially in the collagen fiber.

Risk factors for developing plantar fasciitis can be intrinsic or extrinsic. Intrinsic factors include age, gender, body weight, heel spurs, nerve entrapment, systemic disease, biomechanical dysfunction, and genetics. Extrinsic factors include footwear, sport, lifestyle, foot/ankle/leg deformities, and occupation. Diagnosis for plantar fasciitis is clinical and patients typically present with ‘start-up pain’, sharp pain at the plantar medial aspect of the heel on first walking in the morning and after a period of rest that gets better after walking for a while. Pain usually worsens at the end of the day and also with impact sports and activities. Tenderness on examination is located at the plantar aspect of the medial calcaneal tuberosity.

This condition usually has a significant impact on a patient’s quality of life during the time of their symptoms, and although the majority of cases settle over a period of six to twelve months, at least 10–20 % of patients have ongoing symptoms that limit them beyond the one year.

A wide variety of conservative therapies can be used to treat patients with plantar fasciitis. Conservative therapies include rest or activity modification, stretches, tension night splints, taping, orthotics proper footwear, footwear inserts such as heel cups or arch supports, and oral anti-inflammatory agents, it also includes modalities such as shockwave therapy, ultrasound, and laser therapy.

Extracorporeal shockwave therapy (ESWT) might have a role in treating patients with chronic plantar fasciitis before consideration of more invasive procedures. ESWT is the use of inaudible, high-energy sound waves generated from an external machine placed on the skin that passes through tissue layers and is thought to promote a healing response.

 ESWT has been used in a range of musculoskeletal disorders, including chronic tendinopathies, and some evidence of benefit has been shown in patients with chronic plantar fasciitis.

In ESWT, electrohydraulic, piezoelectrical, and electromagnetic processes produce shock waves. This may disrupt sensory non-myelinated nerve fibers and induce neovascularization and production of collagen in degenerative tissues  Due to its non-invasive nature, rapid recovery, and comfort for patients’ daily lives, extracorporeal shock wave therapy (ESWT) has been commonly used as an alternative treatment choice for PF for decades.

As treatment options for Plantar Fascitis, both centered shock wave (FSW) and radial shock wave (RSW) treatments have recently been introduced. RSW spread from the applicator is

not tissue-focused relative to FSW. (i) The radial technique can be used to treat the painful region instead of a point, and the advantage of RSW therapy is the ended treatment area, although there is evidence showcasing the  usefulness of focused shockwave therapy for treatment of plantar fasciitis too.

Matrix Rhythm Therapy (MRT) is the latest advancement in physiotherapy which uses the basic concept of vibration and massage. MRT was founded by Dr. Ulrich G. Randoll. It is directly derived from the clinical and fundamental video microscopic research of Erlangen University ithe n 1990s.

MRT is a cell biological therapy that activates and rebalances special physiological vibrations of skeletal muscles and the nervous system. During any disease or derailment, energy metabolism is deficient at the cellular level and it must be normalized before any adequate therapy. MRT reactivates the cell metabolism and normalizes the physiological process by depth-effective rhythmical phase synchronous magneto-mechanical oscillations. MRT is modulated between 8-12 Hz of frequency. In this process of oscillation and vibration, cells are stimulated and entire re tissue is rhythmically resynchronized.The contracted areas of musculature will be inductively relaxed by increased circulation which increases oxygenated blood followed by ATP synthesis and dissolution of the tension. The immediate effect can be seen as relaxation of tissue, muscle and fascia. This relaxation remains longer and maintained as the metabolic process at the cellular level are regulated and oxygen supply to cells is improved.

This therapy is simple and carries no side effects. Therapy is administered via an electrically powered oscillator (resonator) with an asymmetric treatment head (cam-type) which produces the mechanical oscillations that are generated by magnetic sinusoidal phase-synchronized field, and these oscillations are then supplied by the treatment head to the affected area.

In summary, this study aims to contribute valuable insights to the field of musculoskeletal medicine by evaluating and comparing Extracorporeal Shock Wave Therapy and Matrix Rhythm Therapy in the context of plantar fasciitis treatment. The results of this research endeavor will potentially inform healthcare practitioners and patients alike, guiding them toward the most appropriate and effective treatment choice for this debilitating condition.

 NEED FOR STUDY:

There are various treatment options available for plantar fasciitis, including physical therapy, orthotics, corticosteroid injections, and surgical interventions. Shockwave therapy and matrix rhythm therapy are two emerging non-invasive treatments in the field of physiotherapy.While both shockwave therapy and matrix rhythm therapy have been used to treat plantar fasciitis, there is lacunae of well-designed, comparative studies that directly compare these therapies in terms of pain reduction, range of motion and functional recovery in individuals with this condition.

A comparative study can provide robust evidence to inform healthcare professionals, leading to more informed and effective treatment choices.The findings of the study can empower patients by providing them with information about the relative benefits and risks of different treatment options, allowing them to make more informed decisions about their care.

 
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