CTRI Number |
CTRI/2023/03/050197 [Registered on: 01/03/2023] Trial Registered Prospectively |
Last Modified On: |
22/02/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Reducing pain & disability in plantar fasciitis with pes planus by conservative methods. |
Scientific Title of Study
|
A comparative study of reducing pain and improvement of foot function related disability in chronic plantar fasciitis with mild to moderate pes planus |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Krishnendu Roy |
Designation |
Pgt |
Affiliation |
Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH |
Address |
Room No: 7, PMR OPD, Department of Physical Medicine & Rehabilitation,
Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH,
11, lala lajpat rai sarani, kolkata-700020
Kolkata WEST BENGAL 700020 India |
Phone |
9433377303 |
Fax |
|
Email |
krishnendu.mbbs@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Jayanta Saha |
Designation |
Guide (Sr Consultant) |
Affiliation |
Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH. |
Address |
Room no:7, PMR OPD, Dept of Physical Medicine & Rehabilitation, Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH.
11, lala lajpat rai sarani, kolkata-700020
Kolkata WEST BENGAL 700020 India |
Phone |
9433094843 |
Fax |
|
Email |
djayantas@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Krishnendu Roy |
Designation |
Pgt |
Affiliation |
Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH |
Address |
Room No: 7, PMR OPD, Department of Physical Medicine & Rehabilitation,
Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH,
11, lala lajpat rai sarani, kolkata-700020
Kolkata WEST BENGAL 700020 India |
Phone |
9433377303 |
Fax |
|
Email |
krishnendu.mbbs@gmail.com |
|
Source of Monetary or Material Support
|
Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH,
11, lala lajpat rai sarani, kolkata-700020 |
|
Primary Sponsor
|
Name |
SAMBHUNATH PANDIT HOSPITAL |
Address |
11, LALA LAJPAT RAI SARANI, KOLKATA-700020 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
Name |
Address |
DR KRISHNENDU ROY |
2/O, HO CHI MINH SARANI, SANJIVPALLY, BEHALA, KOLKATA-700034 |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Krishnendu Roy |
Room No:7, PMR OPD, Dept of PMR, Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH, |
Sambhunath Pandit Hospital, Annex-2 of IPGME&R & SSKMH,
11, lala lajpat rai sarani, kolkata-700020 Kolkata WEST BENGAL |
9433377303
krishnendu.mbbs@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IPGMER RESEARCH OVERSIGHT COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M722||Plantar fascial fibromatosis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
INJECTION OF TRIAMCINOLONE ACETONIDE |
GROUP-A - Patients will receive Injection of 2ml of a suspension containing 20mg Triamcinolone acetonide(0.5 ml) and 2% solution of lignocaine (1.5 ml) without adrenaline, near the origin of plantar fascia followed by therapeutic stretching exercise and a shoe with raise medial arch and analgesic as paracetamol 500mg sos.
Dose: 20mg
Frequency: single dose
Route of administration: intra articular
Total duration: single dose
|
Comparator Agent |
ULTRA SOUND THERAPY |
GROUP-B – Patients will receive Therapeutic Ultrasound for 2 weeks followed by therapeutic starching exercise and a shoe with raise medial arch and analgesic as paracetamol (500mg) sos.
Therapeutic Ultrasound will be as follows:
Duration – 6days/week x 2Weeks,
3 minutes on each region (cacaneal medial tuberosity and on the 2cm distal to tuberosity) each session.
Intensity- 2 watt/cm2
Frequency- 1 MHZ
Mode- continuous mode
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1) Clinically confirmed cases of chronic plantar fasciitis (duration more than 3 months)
2) Pes planus (mild to moderate) confirmed by AP & weight bearing lateral X-Ray of foot and ankle.
|
|
ExclusionCriteria |
Details |
1] Patients who are not willing or not in a sound mental state to give consent
2] Infection of foot and ankle for last 6 months
3] Tumours of foot and ankle
4] Recent fracture in last 6 months
5] Uncontrolled Diabetes Mellitus
6] Uncontrolled Hypertension
7] Patients with neurological deficits (motor, sensory)
8] Charcot atrophy
9] Foot deformity other than pesplanus
10] Patients with bleeding disorders
11] Patients with Psychiatric disorders
12] Patients with implanted pacemaker
13] Patients with skin disease
14] Deformity due to advanced leprosy, buerger’s disease
15] Known hypersensitivity to lignocaine
16] Rheumatoid arthritis
17] Gout
18] Pregnancy
19] Patients on anticoagulants
20] Previous steroid injections within past 6 months
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
1)To assess any improvement in VAS score after corticosteroid injection
2)To assess any improvement in VAS score after UST
|
1) 0 WEEK
2) 4 WEEK
3) 8 WEEK
4) 12 WEEK |
|
Secondary Outcome
|
Outcome |
TimePoints |
1) To assess any improvement in FFI score.
2)To compare improvement in both the groups on the basis of those above parameters.
|
1) 0 WEEK
2) 4 WEEK
3) 8 WEEK
4) 12 WEEK |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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
|
Phase 3 |
Date of First Enrollment (India)
|
01/03/2023 |
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
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
SUMMARY OF THE PROPOSAL Plantar fasciitis, one of the most common causes of heel pain, presents a challenge and treated by health care professionals. It affects both sedentary and athletic people and is thought to result from chronic overload and biomechanical abnormalities either from lifestyle or exercise which results in pain and inflammation of plantar fascia. The exact cause remains poorly understood. Limited data from case-control studies reveal possible contributing factors of obesity, occupations with prolonged standing, pes planus, pes cavus (high arches) reduced ankle dorsiflexion less than 10°, and inferior calcaneal exostoses (heel spurs). There is a high incidence in runners, and there could be contributions from repetitive micro trauma, faulty running shoes or the running surface, but evidence is limited. In the case of flatfoot, the subtalar joint remains pronated after foot is flat before mid-stance and midtarsal joint is not locked. (5) When abnormal weight-bearing condition persists and the talocalcaneus joint gets chronically subluxed, the foot cannot support the rigid propulsion for the normal gait cycle. After heel strike during the first half of the stance phase of the gait cycle, the tibia turns inward and the foot excessively pronates to allow flattening of the foot. This mechanism stretches the plantar fascia. As the foot progresses from foot-flat to push-off, the toes dorsiflex and the plantar fascia tightens. As the plantar fascia extends distal to the metatarsal head, tension causes the head to depress and the arch to rise. The plantar fascia pulls on its medial tubercle origin with more effort to create calcaneus inversion in a flatfoot subject with heel valgus. Therefore, the repetitive traction placed on the plantar fascia during walking or running may lead to microtears and inflammatory response. Historically a broad range of conservative therapies have been used to treat plantar fasciitis. Non-surgical treatment includes rest, heat, ice pack, stretching exercise, foot orthotics, night splinting, taping, topical medications, oral non-steroidal anti-inflammatory drugs (NSAIDs), extracorporeal shock waves, laser, and percutaneous injection with steroids, autologous blood and platelet-rich plasma. Surgical options include release of plantar fascia, ultrasound-guided fasciotomy and co-ablation surgery. Several studies compared various treatment modalities with various degrees of success rate, but there is no clear-cut treatment protocol. For the majority of patients, plantar fasciitis is a self-limiting condition and can be treated effectively by nonsurgical treatments. Present study is intended for evaluating the comparative efficacy of corticosteroid injection against ultra sound therapy with stretching exercise, shoe modification with medial arch support, analgesics in SOS are common in all groups. Not many studies have been done to compare these two standard methods in treatment of Plantar Fasciitis with pes planus (mild to moderate). After taking informed written consent, the information about history taking, detailed clinical examination and investigations will be included in a predesigned study Performa. The obtained data will be analysed using appropriate statistical technique |