Protocol summary

Study aim
To compare the effectiveness subtalar mobilization with mulligan technique on pain and functional limitations versus conventional physiotherapy in patients with Planter Fasciitis
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
The data was collected from Prime Care Hospital, Faisalabad. The patients were divided into two groups by using card allocation method. In group-A patients were treated with subtalar mobilization with Mulligan Technique and in group-B patients were treated with Convention physiotherapy treatment that were include a session of therapeutic Ultrasound for 10 minutes. Patients in both the groups received rigid tapping as standard treatment. Each Patient receives two treatment sessions per week with maximum eight treatment sessions over the period of 3 weeks.
Participants/Inclusion and exclusion criteria
Enclusion Criteria Age 30–60 years. Patients of both Genders Main presenting complaint of Heel & Foot pain Limitation of Range of Motion at ankle joint due to heel pain Pain allocated at the bottom of heel and produced by pressure Pain in the morning at first steps or after prolonged non-weight bearing Exclusion criteria History of trauma, acute and chronic pathology Patients with any Systemic Illness (e.g. Rheumatism)• Fracture below knee during the last year Prior foot surgeries
Intervention groups
n group-A patients were treated with subtalar mobilization with Mulligan Technique and rigid tapping as standard treatment. Each Patient receives two treatment sessions per week with maximum 6 treatment sessions over the period of 3 weeks.
Main outcome variables
Outcomes were measured by Visual Analogue Scale and Foot & Ankle Disability Index at baseline, after 1st and 2nd week and at the end of the treatment.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200221046567N2
Registration date: 2020-04-18, 1399/01/30
Registration timing: prospective

Last update: 2020-04-18, 1399/01/30
Update count: 0
Registration date
2020-04-18, 1399/01/30
Registrant information
Name
Muhammad Kashif
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 41 8777210
Email address
kashif.shaffi@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2638-03-30, 2017/01/10
Expected recruitment end date
2638-10-02, 2017/07/10
Actual recruitment start date
2638-04-04, 2017/01/15
Actual recruitment end date
2638-10-12, 2017/07/20
Trial completion date
2638-10-12, 2017/07/20
Scientific title
Comparison of Subtalar Mobilization with Conventional Physiotherapy Treatment for the ‎Management of Planter Fasciitis
Public title
Comparison of Subtalar Mobilization with Conventional Physiotherapy Treatment for the ‎Management of Planter Fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30–60 years. Patients of both Genders Main presenting complaint of Heel & Foot pain Limitation of Range of Motion at ankle joint due to heel pain Pain allocated at the bottom of heel and produced by pressure Pain in the morning at first steps or after prolonged non-weight bearing
Exclusion criteria:
History of trauma, acute and chronic pathology Patients with any Systemic Illness (e.g. Rheumatism)• Fracture below knee during the last year Prior foot surgeries A positive diagnosis of Tarsal Tunnel Syndrome (TTS) / Fat Pad Syndrome
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 60
Actual sample size reached: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 treatment group
Blinding (investigator's opinion)
Single blinded
Blinding description
The study was single-blinded as assessors of the study was blinded of the treatment group to which the patient will be allocated.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethical Committee,Riphah College of Rehabilitation Sciences, Pakistan.
Street address
Satiana Road
City
Faisalabad
Postal code
3800
Approval date
2638-02-01, 2016/11/12
Ethics committee reference number
RCRAHS/ERB/112

Health conditions studied

1

Description of health condition studied
PLANTER FASCIITIS
ICD-10 code
M79.671
ICD-10 code description
Heel pain, plantar fasciitis, subtalar mobilization, manual therapy, rigid taping.

Primary outcomes

1

Description
Pain
Timepoint
Baseline and on 1 and 2 week and end of intervention
Method of measurement
Visual Analogue Scale

2

Description
Foot and Ankle Functional Limitations
Timepoint
Baseline and on 1 and 2 week and end of intervention
Method of measurement
Foot and Ankle Disability Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: will get subtalar mobilization (Mulligan Technique) +rigid tapping as standard ‎treatment for 40 minutes of session. Each Patient receives two treatment sessions per week ‎over the period of three weeks‎.
Category
Rehabilitation

2

Description
Control group: will get subtalar conventional physiotherapy +rigid tapping as standard ‎treatment for 40 minutes of session. Each Patient receives two treatment sessions per week ‎over the period of three weeks‎.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Prime Care Hospital Faisalabad
Full name of responsible person
Muhammad Kashif
Street address
Satiana Road
City
Faisalabad
Postal code
3800
Phone
+92 41 8777210
Email
kashif.shaffi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Kashif
Street address
Satiana Road
City
Faisalabad
Postal code
3800
Phone
+92 41 8777210
Email
kashif.shaffi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Riphah International University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Kashif
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Satiana Road
City
Faisalabad
Province
Punjab
Postal code
3800
Phone
+92 41 8777210
Email
kashif.shaffi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Kashif
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Satiana Road
City
Faisalabad
Province
Punjab
Postal code
3800
Phone
+92 41 8777210
Fax
Email
kashif.shaffi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Kashif
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Satiana Road
City
Faisalabad
Province
Punjab
Postal code
3800
Phone
+92 41 8777210
Fax
Email
kashif.shaffi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
IPD collected for the primary outcome measure only
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
who want to compare/conduct studies on comparison of subtalar mobilization with conventional treatment for the management of planter fasciitis
From where data/document is obtainable
Principal Investigator by email: kashif.shaffi@gmail.com
What processes are involved for a request to access data/document
An email request to Principal Investigator email: kashif.shaffi@gmail.com
Comments
Loading...