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.: PACTR202305704715004 Date of Approval: 09/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of tibial nerve mobilization in patients with Tarsal tunnel syndrome
Official scientific title Short-term Effectiveness of tibial nerve flossing technique in patients with Tarsal tunnel syndrome
Brief summary describing the background and objectives of the trial PURPOSE: To investigate the short-term effect of the tibial nerve flossing technique on foot pain, NCV of the tibial nerve, and ankle dorsiflexion ROM in patients with tarsal tunnel syndrome. BACKGROUND: Tarsal tunnel syndrome (TTS) is the most common entrapment of the tibial nerve. Treating tarsal tunnel syndrome remains difficult due to diagnostic uncertainty and a lack of knowledge regarding which patients may benefit from conservative versus surgical care. Evidence showing patients with TTS benefit from neural mobilization is still limited.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2023
Actual trial start date
Anticipated date of last follow up 29/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 54
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tibial nerve gliding technique Three times per week Four weeks Patients will receive stretching exercises, TENS & US waves. Patients will receive a tibial nerve flossing technique in addition to the mentioned interventions. 27
Control Group Conventional Physiotherapy Three sessions per week Four weeks All participants will receive stretching exercises, TENS & US waves. 27 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Individuals should be diagnosed and referred by an orthopedic surgeon, presented with unilateral tarsal tunnel syndrome, and classified as not having an indication for surgery. - With at least 3-month history of pain within the tarsal tunnel or referred distally to the foot or proximally to the leg, with a minimum pain level of 2 on a 10 cm visual analog pain scale (VAS). - With limited ROM of the ankle joint on the affected side. - Patients with common symptoms of TTS as +ve Tinel’s sign and weakness of muscle innervated by branches of the tibial nerve. - To be able to understand and follow the directions of the intervention protocols. - Having comorbidities or orthopedic or postural problems that could confound the outcomes. - Patients with diabetic neuropathy or other entrapment neuropathies. - Having undergone surgery related to the lower extremity or lumbar spine. - Alcohol and/ or smoking addiction. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
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 11/12/2022 Faculty of Physical Therapy Ethical Committee
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El-Zayat St. Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Nerve conduction study: Distal latency of the posterior tibial nerve will be evaluated before interventions and just after 4 weeks of intervention duration. Before and just after end of treatment
Primary Outcome Pain intensity: will be measured using the visual analog scale before and after treatment. Before and just after end of treatment
Secondary Outcome Ankle dorsiflexion ROM: will be measured using an electro-goniometer before and after the treatment duration of 4 weeks. before and just after end of treatment
Secondary Outcome Dorsiflexion/ Eversion Test: Provocation test to reproduce tarsal tunnel syndrome symptoms of tenderness in the area of palpation, or pain/ numbness in the toe, ball of the foot, or heel. before and just after end of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy 7 Ahmed Al-Zayat St., Bein El-Sarayat, Giza, Egypt Giza 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded 7 Ahmed El Zayat St Giza 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shaymaa Salem Regional service road, New Assiut Assiut Governorate 71515 Egypt Individual
Secondary Sponsor Bassam El Nassag 177 Gisr El Sweiz St., Heliopolis Cairo 11757 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bassam El Nassag bassamesmail79@gmail.com +201009507019 177 Gisr El Sweiz St., Heliopolis
City Postal code Country Position/Affiliation
Cairo 11757 Egypt Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Amina Awad draminaawad@gmail.com +201010085342 28 Al Fardous St., Al Agouza
City Postal code Country Position/Affiliation
Giza 12654 Egypt Faculty of Physical Therapy Cairo university
Role Name Email Phone Street address
Public Enquiries Shaymaa Salem Drshymaasalem@yahoo.com +201005228820 Regional service zone, New Assuit
City Postal code Country Position/Affiliation
Assuit Governorate 71511 Egypt Sphinx university Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Study Protocol Beginning 9 months and ending 36 months the following article publication - Access to data shall be permitted to: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. - Data analysis permitted: To achieve aims in the approved proposal. - Mechanism by which data will be available: The proposal should be directed to xxx@yyy. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third-party website (Link to be included).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information