To compare the effects in concentric and eccentric progressive resistive exercises on pain and disability in posterior tibial tendon dysfunction.
Design
A concealed, randomized, single blinded, clinical trial with a parallel group design of 30 patients. Lottery method will be used for Randomization.
Settings and conduct
Haq Orthopedic Hospital, Rabia Welfare hospital, Kanaan Physiotherapy and Spine Clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Age: 40–60 years
• Current complaint of foot and ankle pain that has lasted for three months or more
• Flexible pes planovalgus deformity in the clinical assessment
• Pes planovalgus foot deformity with longitudinal arch flattening verified by radiograph
Exclusion criteria:
• Rigid foot deformity
• Acute infection or alcohol addiction limiting participation in study protocol Acute use of local or systemic analgesics
• Acute overuse or traumatic injury to the lower leg (excluding pes planovalgus associated pathology)
• Prior surgery to the lower limb
Intervention groups
Group 1 will receive stretching exercises and foot orthosis and concentric progressive resistive exercises (CPR Group) including plantar flexion and eversion of ankle joint.
Group 2 will receive stretching exercises and foot orthosis eccentric progressive exercises (OE Group) including dorsiflexion and inversion of ankle joint.
Main outcome variables
Pain and Disability: Pain will be measured through Numeric Pain Rating Scale (NPRS) and disability will be measured through Pain disability index (PDI) scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190715044216N6
Registration date:2022-02-10, 1400/11/21
Registration timing:registered_while_recruiting
Last update:2022-02-10, 1400/11/21
Update count:0
Registration date
2022-02-10, 1400/11/21
Registrant information
Name
Naveed Anwar
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
naveedanwar982@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-01, 1400/10/11
Expected recruitment end date
2022-06-30, 1401/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of concentric and eccentric progressive resistive exercises on pain and disability in posterior tibial tendon dysfunction
Public title
comparison of concentric and eccentric progressive resistive exercises on pain and disability in posterior tibial tendon dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 40–60 years •
Current complaint of foot and ankle pain that has lasted for three months or more
Flexible pes planovalgus deformity in the clinical assessment
Pes planovalgus foot deformity with longitudinal arch flattening verified by radiograph
Exclusion criteria:
Rigid foot deformity
Acute infection or alcohol addiction limiting participation in study protocol Acute use of local or systemic analgesics
Acute overuse or traumatic injury to the lower leg (excluding pes planovalgus associated pathology)
Prior surgery to the lower limb
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Taking into account the above mentioned inclusion and exclusion criteria, patients will be recruited in the study through convenient sampling technique and then will be randomly assigned to each group according to consort guideline 2010. Written informed consent will be taken. After enrollment into study, patient will be allocated either to Group 1 and Group 2 by lottery method. No. of Chits will be equal to total sample size. Each patients will be requested to draw a chit from the box and after that patient will be recruited into either Group 1 and Group 2
Blinding (investigator's opinion)
Single blinded
Blinding description
1. It will be a single blinded study
2. Participants of both groups will be kept unfamiliar to the treatment protocol by lottery method.
3. Participants of both groups will be called for treatment on alternate days in a week.
4. The health care provider (physical therapist) will be aware to the whole treatment procedure that will be provided to the participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Riphah international research and ethics committe
Street address
28M Quid e azam industrial estate kot lakhpat lahore
City
Lahore
Postal code
57400
Approval date
2021-06-07, 1400/03/17
Ethics committee reference number
REC/RCR & AHS/21/0106
Health conditions studied
1
Description of health condition studied
Posterior Tibial Tendon Dysfunction
ICD-10 code
M76.82
ICD-10 code description
Posterior tibial tendinitis
Primary outcomes
1
Description
Pain
Timepoint
Intervention treatment will be given to subjects 2 sessions per week and 2 sets per day, 1 set in clinical setup and 2nd for home plan. Total intervention period will be of 6 weeks.
Method of measurement
Pain Disability Index (PDI)
2
Description
Disability
Timepoint
Intervention treatment will be given to subjects 2 sessions per week and 2 sets per day, 1 set in clinical setup and 2nd for home plan. Total intervention period will be of 6 weeks.
Method of measurement
Numeric Pain Rating Scale (NPRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:will perform posterior tibialis exercise with ankle in planter flexion and eversion in supine lying position +heating packs for 20 minutes and A Thera-band will be place under the Ankle and advice the patient to extend their ankle by pushing the downward of ankle into thera-band while keep your ankle in planter flexion during exercise.The hold time for isometric contraction will be 10 sec follow by a rest period of 5 sec in between the contractions. Each patient will be complete 2 sessions in a day , in each session consist of 1 set of 10 repetitions of planter flexion perform once at the hospital and once at home for the 2 days/6-week time for testing up:
Category
Rehabilitation
2
Description
Intervention group 2:will perform posterior tibialis exercise with ankle in dorsiflexion and inversion in supine lying position + heating packs for 20 minutes and A Thera-band will be place above the Ankle and advice the patient to flex their ankle by pushing the upward of ankle into thera-band while keep your ankle in dorsiflexion during exercise.The hold time for isometric contraction will be 10 sec follow by a rest period of 5 sec in between the contractions. Each patient will be complete 2 sessions in a day , in each session consist of 1 set of 10 repetitions of planter flexion perform once at the hospital and once at home for the 2 days/6-week time for testing up:
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rabia Welfare Hospital
Full name of responsible person
Mr. Jameel
Street address
house # 9, street # 21, Mohala Neewa chah mira lahore
City
Lahore
Postal code
54900
Phone
+92 348 4266429
Email
drabduljabbar743725@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Jabbar
Street address
house # 9, street # 21, Mohala Neewa chah mira lahore
City
Lahore
Postal code
54900
Phone
+92 348 4266429
Email
drabduljabbar743725@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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 Jabbar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house # 9, street # 21, Mohala Neewa chah mira lahore
City
Lahore
Province
punjab
Postal code
54900
Phone
+92 348 4266429
Email
drabduljabbar743725@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Jabbar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house # 9, street # 21, Mohala Neewa chah mira lahore
City
Lahore
Province
Punjab
Postal code
54900
Phone
+92 348 4266429
Email
drabduljabbar743725@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Jabbar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house # 9, street # 21, Mohala Neewa chah mira lahore
City
Lahore
Province
Punjab
Postal code
54900
Phone
+92 348 4266429
Email
drabduljabbar743725@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
comparison of concentric and eccentric progressive resistive exercises on pain and disability in posterior tibial tendon dysfunction
When the data will become available and for how long
30-6-2022
To whom data/document is available
people working in academic situation
Under which criteria data/document could be used
Author will review the request
From where data/document is obtainable
drabduljabbar743725@gmail.com
What processes are involved for a request to access data/document
request will be entertained through email after which people working in academic institutions will be granted request