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Effects of Gastrocnemius recession versus physical therapy in chronic plantar fasciitis

Protocol summary

Study aim
The study aims to evaluate the effects of gastrocnemius recession versus physiotherapy in chronic plantar fasciitis.
Design
Parallel, 40 Sample size, Randomized Controlled Trial, single-blinded
Settings and conduct
The trial will be conducted in the Physiotherapy Department of Punjab Social Security Health Management Company Hospital. Assessor will be completely blind to outcomes.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age 30-50 years individuals, Male and female both, Heel pain lasting > 3 months, Pain in the morning, Tenderness over medial plantar fascia insertion, Positive Silfverskiöld test Exclusion Criteria: Degenerative arthritis of the hindfoot joints, Systemic joint disease, Previous injury or surgery to the foot or ankle, Inoperable due to comorbidity
Intervention groups
Group A. PHYSICAL THERAPY PHONOPHORESIS, STRETCHING, and MANUAL THERAPY were done on alternate days for 4 weeks. The calf muscle and/or plantar fascia–specific stretching will be used to provide pain relief and improvement in calf muscle flexibility 3 times a day (3 minutes) stretching time, for three months in-home plan. Group B. GASTROCNEMIUS RECESSION Patients randomized to surgery will be operated on with a proximal medial gastrocnemius recession (PMGR) as described by Barouk. Patients were instructed to continue the stretching exercises and fully weight-bear from the first postoperative day. If needed, the patients were allowed to use crutches during the first 2 weeks after surgery.
Main outcome variables
numeric rating scale, Foot and Ankle Ability Measure (FAAM)Activities of Daily Living Subscale, ankle hindfoot scale, The Short Form–36 (SF-36)

General information

Reason for update
Acronym
RCT
IRCT registration information
IRCT registration number: IRCT20210704051785N3
Registration date: 2023-08-05, 1402/05/14
Registration timing: retrospective

Last update: 2023-08-05, 1402/05/14
Update count: 0
Registration date
2023-08-05, 1402/05/14
Registrant information
Name
Sarwat Anees
Name of organization / entity
Sharif medical and dental college
Country
Pakistan
Phone
+92 42 35397101
Email address
sarwatasifmehmood@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-01, 1402/04/10
Expected recruitment end date
2023-07-01, 1402/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Gastrocnemius recession versus physical therapy in chronic plantar fasciitis
Public title
surgery versus physiotherapy which treatment is better for heel pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Heel pain lasting > 3 months Pain in morning(morning stiffness) Tenderness over medial plantar fascia insertion Positive Silfverskiöld test not recieved physiotherapy session
Exclusion criteria:
Degenerative arthritis of the hindfoot joints Systemic joint disease Previous injury or surgery to the foot or ankle Inoperable due to comorbidity
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The sealed envelope method will be used for random allocation. 40 sealed envelopes (20 for Group A and 20 for Group B) will be prepared. 20 envelopes will contain the letter A, and 20 will include the letter B on a card. The patient will be asked to choose one envelope. Treatment will be given according to treatment group (Group A: control, Group B: experiment).
Blinding (investigator's opinion)
Single blinded
Blinding description
Senior physiotherapists will assess the patient before and after treatment. Senior physiotherapist/assessor will be blinded entirely about patient allocation group (control/intervention).
Placebo
Not used
Assignment
Parallel
Other design features
no

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
the superior university ethics committee
Street address
raiwind road, lahore
City
lahore
Postal code
55150
Approval date
2023-06-10, 1402/03/20
Ethics committee reference number
Ref:03-PEAC-1-23

Health conditions studied

1

Description of health condition studied
Plantar fasciitis, heel pain
ICD-10 code
M72.2
ICD-10 code description
Plantar fascial fibromatosis

Primary outcomes

1

Description
pain intensity
Timepoint
numeric pain rating scale will be measured at basline and at 3 months and at 6 months
Method of measurement
measured by numeric pain rating scale

2

Description
foot and ankle function involving a range of daily activities
Timepoint
foot and ankle function involving a range of daily activities will be assessed at baseline and at 3 months and at 6 months.
Method of measurement
foot and ankle function involving a range of daily activities(FAAM-ADL) scale used

3

Description
the american orthopedic foot and ankle society ANKLE-HINDFOOT scale
Timepoint
will be assessed at baseline and at 3 months and at 6 months.
Method of measurement
AOFAS ankle hindfoot scale used

Secondary outcomes

1

Description
health related quality of life
Timepoint
will be assessed at baseline and at 3 months and at 6 months.
Method of measurement
the short form SF-36 used.

Intervention groups

1

Description
Intervention group: Phonophoresis with ketoprofen gel will reduce pain on alternate days for 4 weeks. Stretching Calf muscle and plantar fascia–specific stretching will be used to relieve pain and improve calf muscle flexibility 3 times a day (3 minutes) stretching time, for three months in the home plan. Manual therapy procedures include talocrural joint posterior glide, subtalar joint lateral glide, anterior and posterior glides of the first tarsometatarsal joint, and subtalar joint distraction manipulation, done on alternate days for 4 weeks
Category
Treatment - Other

2

Description
Intervention group: Patients randomized to surgery will be operated with a proximal medial gastrocnemius recession(PMGR) as described by Barouk(17)(Figure 1). No additional procedures will be performed. The operation will be performed with the patients in a prone position under local anesthetic or general anesthesia. A 3-cm transverse skin incision was made in the popliteal fossa, the fascia was opened, and the medial gastrocnemius with its tendon was located. The tendon was then cut while lifting the gastrocnemius with clamps, and care was taken to cut only the white tendon while sparing the underlying muscle. While performing a dorsiflexion movement of the ankle, careful palpation of the muscle was done to ensure that all tendon strands were cut completely. The incision was closed in layers, and only soft dressings were applied. Patients were instructed to continue the stretching exercises and fully weight-bear from the first postoperative day. If needed, the patients were allowed to use crutches during the first 2 weeks after surgery. Sutures were removed 2 weeks after surgery.Calf muscle and plantar fascia–specific stretching will be used to relieve pain and improve calf muscle flexibility 3 times a day (3 minutes) stretching time, for three months in the home plan
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Punjab Social Security Health Management Company Hospital, Raiwind, Lahore
Full name of responsible person
Sarwat Anees
Street address
8km manga road, raiwind
City
lahore
Postal code
55150
Phone
+92 303 4846498
Email
psshmc@0rg.pk
Web page address

2

Recruitment center
Name of recruitment center
the sharif city polyclinic raiwind
Full name of responsible person
Sarwat Anees
Street address
Sharif polyclinic, near Muzammil Mart, railway road, raiwind
City
lahore
Postal code
55150
Phone
+92 303 4846498
Fax
+92 303 4846498
Email
sharifmedicalcity@org.edu.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
sharif medical and dental college
Full name of responsible person
Sarwat Anees
Street address
Sharif polyclinic, near doce bakers, railway road, raiwind
City
raiwind
Postal code
55150
Phone
+92 303 4846498
Fax
+92 42 37860122
Email
sarwatasifmehmood@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
funding
Proportion provided by this source
1
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Punjab Social Security Health Management Company Hospital
Full name of responsible person
Sarwat Anees
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Sharif Polyclinic, near Doce Bakers, Railway Road, Raiwind
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 303 4846498
Email
sarwatasifmehmood@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sharif medical and dental college
Full name of responsible person
Sarwat Anees
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Sharif polyclinic, near Muzammil Mart, railway road, raiwind
City
Raiwind
Province
Punjab
Postal code
55150
Phone
+92 303 4846498
Fax
Email
sarwatasifmehmood@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sharif medical and dental college
Full name of responsible person
Sarwat Anees
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Sharif polyclinic, near doce bakers, railway road raiwind
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 42 35397101
Fax
Email
sarwatasifmehmood@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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