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CTRI Number  CTRI/2024/09/074240 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 23/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Comparing Graston Technique and Positional Release Technique: Effects on Pain, Function, and Pressure Threshold in Chronic Plantar Fasciitis 
Scientific Title of Study   Comparative Effects of Graston Technique Vs Positional Release Technique on Pain, Function and Pain Pressure Threshold in Patients with Chronic Plantar Fasciitis- an Experimental 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  Patel Hetvi Janakbhai 
Designation  Post Graduate student 
Affiliation  SPB physiotherapy college 
Address  OPD no. 1 and 4, Dept. of musculoskeletal physiotherapy, SPB Physiotherapy college, Ugat, Bhesan, Surat, Gujarat, India.

Surat
GUJARAT
395005
India 
Phone  9879863323  
Fax    
Email  patelhetvi0407@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dharti Pansala 
Designation  Associate Professor 
Affiliation  SPB Physiotherapy college 
Address  OPD no. 1 and 4, Dept. of musculoskeletal physiotherapy, SPB Physiotherapy college, Ugat, Bhesan, Surat, Gujarat, India.

Surat
GUJARAT
395005
India 
Phone  8141570075  
Fax    
Email  physiodharti@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Dharti Pansala 
Designation  Associate Professor 
Affiliation  SPB Physiotherapy college 
Address  OPD no. 1 and 4, Dept. of musculoskeletal physiotherapy, SPB Physiotherapy college, Ugat, Bhesan, Surat, Gujarat, India.

Surat
GUJARAT
395005
India 
Phone  8141570075  
Fax    
Email  physiodharti@yahoo.co.in  
 
Source of Monetary or Material Support  
SPB Physiotherapy college, Ugat- Bhesan road, Morabhagal, Rander, Surat, Gujarat, India,395005 
 
Primary Sponsor  
Name  SPB Physiotherapy college 
Address  Ugat- Bhesan road, Morabhagal, Rander, Surat, Gujarat, India,395005 
Type of Sponsor  Research institution 
 
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 
Patel Hetvi Janakbhai  SPB Physiotherapy college  OPD 1 and 4, Department of musculoskeletal physiotherapy, Ugat-Bhesan road, Morabhagal, Rander, Surat, Gujarat, India- 395005
Surat
GUJARAT 		 9879863323

patelhetvi0407@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy for Chronic Plantar Fasciitis  Towel curl up- 10 times with 5 second hold Active ankle movements (ankle dorsiflexion, plantarflexion, inversion and eversion)- 10 times in supine lying position Plantar fascia self-stretch 3 times with a 30 second hold Gastrocnemius muscle stretch- 3 times with a 30 second hold Soleus muscle stretch- 3 times with a 30 second hold 
Intervention  Graston technique  The patient lies in prone with knees bent slightly. GT cream is applied on the plantar surface of the heel and mid-foot. GT treatment (using the sweep technique) is to be given with the Graston tools. To and fro stroking with tolerable force from the medial side of the heel to the metatarsals and from the metatarsals to the medial side of the heel is to be applied for approximately 8 minutes with 60 to 70 strokes/minute with a 5 to 10 second rest interval in between and at a 60° angle on the sole of the foot. Aggressive treatment should be applied with increased force on the area where tissue restriction felt high. At the end of treatment, a cold pack should be applied for 5 minutes.  
Intervention  Positional Release Technique  Patient is placed in prone lying position with the knee flexed to approximately 90° and foot resting on the left hand of the therapist who is standing by the side of the patient. The patient is then asked to dorsiflex the foot so as to accentuate the fibers of the plantar aponeurosis for palpation. The therapist uses her right hand to glide across the aponeurosis with firm pressure from its distal insertions to its proximal origin at the medial calcaneus. The location of any tender points particularly at its origin at the calcaneus is to be noted. Once the most dominant tender point is determined, the therapist sits on the couch and places the toes of the patient in the sulcus of his left shoulder to promote phalangeal flexion. The ankle of the patient is then moved into marked plantarflexion with the left hand of the therapist. The therapist then uses her right hand to apply a light pressure with the pads of the fingers at the location of any trigger point and maintains the pressure until there is reduction in pain or held 2 minutes. Fine tuning involving calcaneal internal or external rotation by the therapist’s left hand based on the location of the pain is applied to maintain the position of most ease (position of less sensitivity). 3 repetitions of this position should be held with rest interval. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients who are ready to give consent and willing to participate in the study if they meet the following criteria.
Patients diagnosed with plantar fasciitis by clinical criteria.
Age group between 25 to 50 years.
Both male and female.
Duration of symptoms more than 6 weeks.
Tenderness of Grade I and II present on palpation on medial calcaneum.
Maximum heel pain with the 1st step in the morning or after prolonged immobilization.
Patient who is able to read and write in English or Gujarati language.
 
 
ExclusionCriteria 
Details  History of fracture, trauma or surgery in the foot or ankle before 6 months.
Congenital or acquired structural foot deformity like pes planus, pes cavus etc.
Subjects who had taken corticosteroid injection in heel before 6 months.
Subjects who are on NSAIDs.
Diabetic foot, open wound or burns.
Heel fat pad syndrome and/or Baxter nerve entrapment.
Subjects using modified footwear.
Subjects diagnosed with any infective condition of foot or any neurological, cardio-pulmonary, psychosomatic disorder.
Tumour or malignancy.
Pregnancy
Calcaneal spur on X-ray.
Subject undergoing any other treatment for the same condition from any other health practitioner.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Pain by NPRS
2. Function by Foot Function Index (FFI)
3. Pain pressure threshold by digital algometer
 		 At baseline and 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   04/10/2024 
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 Yet Recruiting 
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  
Comparative Effects of Graston Technique Vs Positional Release Technique on Pain, Function and Pain Pressure Threshold in Patients with Chronic Plantar Fasciitis- an Experimental Study


1.1 Need of the study
The main purpose of this study is to find out which technique from Graston,  positional release technique and conventional therapy gives more effective results on pain, function and pain pressure threshold in patients with chronic plantar fasciitis. 

1.2 Objective of the study
1.     To evaluate the effect of Graston technique (GT) on pain, function and pain pressure threshold in patients with chronic plantar fasciitis.

      2.     To evaluate the effect of Positional Release Technique (PRT) on pain, function and pain pressure threshold in patients with chronic plantar fasciitis.

     3.    To compare the effect of Graston technique (GT) versus Positional Release technique (PRT) on pain, function and pain pressure threshold in patients with chronic plantar fasciitis.


     1.3 Methodology:

     1. Study design: a pre-post experimental study

     2. Study population: Patients with plantar fasciitis.

     3. Study sample:  Patients of both genders between the age 25-50 years with chronic plantar fasciitis.

     4. Sampling technique: Purposive sampling.


1.4 Inclusion criteria:

Patients who are ready to give consent and willing to participate in the study if they meet the following criteria

 Patients diagnosed with plantar fasciitis by clinical criteria.

 Age group between 25-50 years.

Both male and female.

Duration of symptoms more than 6 weeks.

Tenderness of Grade I and II present on palpation on medial calcaneum.

 Maximum heel pain with the 1st step in the morning or after prolonged immobilization.

 Patient who is able to read and write in English or Gujarati language.


1.5 Exclusion criteria:

History of fracture, trauma or surgery in the foot or ankle before 6 months.

 Congenital or acquired structural foot deformity like pes planus, pes cavus etc.

Subjects who had taken corticosteroid injection in heel before 6 months.

Subjects who are on NSAIDs.

Diabetic foot, open wound or burns.

Heel fat pad syndrome and/or Baxter nerve entrapment.

Subjects using modified footwear.

Subjects diagnosed with any infective condition of foot or any neurological, cardio-pulmonary, psychosomatic disorder.

Tumour or malignancy.

Pregnancy 

Calcaneal spur on X-ray.

 Subject undergoing any other treatment for the same condition from any other health practitioner.


1.6 Procedure:

The participants will be screened on basis of inclusion and exclusion criteria for this study.

Their demographic data will be obtained. 

Assessment of all the outcome measures will be done. 

The participants will be allocated randomly into 3 groups by Computer Generated Random Numbers. 

Group A: Graston technique + Conventional treatment (experimental group)

Group B: Positional Release technique + Conventional treatment (experimental group)

Group C: Conventional treatment (control group)

Total treatment will be 3 sessions per week for 4 weeks.

On the first day of the first week, baseline measurements of pain, function and pain pressure threshold will be taken. Total treatment will be of 4 weeks with 3 sessions per week (alternate day session). Post assessment data of pain, function and pain pressure threshold will be taken at the end of 4 weeks.


 
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