Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202408921930700 Date of Registration: 08/08/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of hamstring flexibility on foot function in plantar fasciopathy
Official scientific title Effects of Hamstring Flossing on Balance and Foot Function in patients with plantar fasciopathy: A Randomized controlled study
Brief summary describing the background and objectives of the trial PURPOSE To investigate the effect of hamstring flossing on the Foot Function Index (FFI) score and overall stability index (OASI) in patients with Plantar Fasciopathy (PF). BACKGROUND Plantar Fasciopathy is one of the most common pathologies evaluated and treated by foot and ankle specialists. Correlation between hamstring tightness and PF has been reported in the literature. Additionally, maintenance of good balance requires adequate muscle flexibility. However, the functional assessment after performing hamstring flexibility exercise in patients with PF has not been studied before. HYPOTHESES There will be no effect of hamstring flossing on the FFI score and OASI in patients with PF. RESEARCH QUESTION Will there be any effect of hamstring flossing on the FFI score and OASI in patients with PF.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Flossing Hamstring Plantar fasciopathy
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/07/2024
Actual trial start date 03/07/2024
Anticipated date of last follow up 03/07/2024
Actual Last follow-up date 03/07/2024
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 31
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Hamstring Flossing in plantar fasciopathy three times per week for three weeks Procedure: Group (A): Control group consisted of fifteen participants, received only the classical treatment protocol for PF (Therapeutic Ultrasound, Moist heat, Stretching of Achilles tendon, stretching of the plantar fascia, and Strengthening exercises for intrinsic foot Muscles). Group (B): study group consisted of fifteen participants, received the classical treatment protocol in addition to hamstring flossing. outcome measure: Foot pain and function was measured by Foot Function Index (FFI). While balance was measured by OASI. 31 Active-Treatment of Control Group
Control Group Effect of hamstring flossing on balance and foot function in plantar fasciopathy three times per week three weeks Patients with plantar fasciopathy with inclusion criteria of hamstring tightness were recruited to receive hamstring flossing band on the thigh aiming to improve hamstring flexibility to investigate effect of hamstring flexibility in addition to conventional physical therapy on foot function and balance 31 Active-Treatment of Control Group
Control Group The effect of conventional physical therapy program on Balance and function in plantar fasciopathy three times per week three weeks Patients with plantar fasciopathy with inclusion criteria of hamstring tightness recieved classical treatment inform of therapeutic ultrasound, moist heat, Achiiles tendon stretch, plantar fascia stretch, and strengthening of intrinsic foot muscles 15 Active-Treatment of Control Group
Experimental Group Effect of hamstring flossing on balance and foot function in plantar fasciopathy three times per week three weeks patients with plantar fasciopathy with inclusion criteria of hamstring tightness recieved hamstring flossing intervention in addition to conventional treatment and measure balance using Over All Stability Index and foot pain and function using Foot Function Index 16
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
They had heel pain and tenderness in the plantar fascia insertion. · They had positive Windlass test. · Their pain score was > 4 out of 10 by using the Visual Analog Scale (VAS). · Their pain was at its highest level during first steps in the morning after waking up and during the walking after period of resting. · Had decreased pain at the onset of activity but worsening as the activity continues. · Their pain level increased by increasing the duration of weight bearing activities. · They had limited hamstring muscle flexibility. · They had been treated for PF with muscle stretching exercises or night splints during the study. · They received another treatment for PF during the study. · They had history of any trauma or strain at hamstring muscle or the plantar area within the last six months. · Their body Mass Index (BMI) was greater than 35 kg/m². · They had recent ankle sprain. · They had radiating pain confused with neurological pain resulting from spinal problems. · They had Osseous structural changes in the foot (pes planus or pes cavus). · They had been diagnosed with systemic inflammatory disease such as Gout, rheumatoid arthritis, fibromyalgia or neuropathy, neurological diseases, and diseases of the central or peripheral nervous system. · Have latex allergy, hypertension, or venous thrombotic disease. Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 60 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/07/2023 FACULTY OF PHYSICAL THERAPY APPLICATION FOR ETHICAL REVIEW
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zaiat Street, Bein El Sarayat, Giza, Egypt, Giza 002376176 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Foot Function Index to measure effect of intervention on foot pain and function after three weeks
Secondary Outcome Balance measured by OverAll Stability Index three weeks
Primary Outcome Foot Function Index three weeks during intervention
Secondary Outcome Over All Stability Index three weeks during intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University 7 Ahmed El Zaiat Street, Bein El Sarayat, Giza, Egypt, Giza 002376176 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded 1/3 ElLassilki Street, El Maadi, Cairo, Egypt Cairo 123456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Cairo University 7 Ahmed El Zaiat Street, Bein El Sarayat, Giza, Egypt, Giza 002376176 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Ahmed eman3ahmed@yahoo.com 00201122211657 7 Ahmed El Zaiat Street, Bein El Sarayat, Giza, Egypt
City Postal code Country Position/Affiliation
Giza 002376176 Egypt Assisstant lecturer
Role Name Email Phone Street address
Public Enquiries Yassmin Mohamed dryassminessam@gmail.com 00201110882022 7 Ahmed El Zaiat Street, Bein El Sarayat, Giza, Egypt,
City Postal code Country Position/Affiliation
Giza 002376176 Egypt Assisstant professor
Role Name Email Phone Street address
Scientific Enquiries Amal Elborady dr_mouly@hotmail.com 00201141441008 7 Ahmed El Zaiat Street, Bein El Sarayat, Giza, Egypt
City Postal code Country Position/Affiliation
Giza 002376176 Egypt Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will individual participant data be available (including data dictionaries)? Yes What data will be shared? Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). What other documents will be available? Not available When will data be available (start and end date)? Beginning 9 months and ending 36 months following article publication Informed Consent Form Data will be available 36 months following publication and ending 6 months following article publication. who will access data? With who? Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose. For what types of analyses? Any purpose By what mechanism will date be made available? Proposal should be directed to eman.ahmed@pt.cu.edu.eg. To gain access, data requestors will need to sign a data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
eth.com@pt.cu.edu.eg…… Yes 29/07/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 29/07/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information