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.: PACTR202209867747025 Date of Approval: 29/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF STABILIZER PRESSURE BIOFEEDBACK ON POST THYROIDECTOMY NECK PAIN IN POSTMENOPAUSAL WOMEN
Official scientific title EFFECT OF STABILIZER PRESSURE BIOFEEDBACK ON POST THYROIDECTOMY NECK PAIN IN POSTMENOPAUSAL WOMEN
Brief summary describing the background and objectives of the trial Thyroid disease asThyroid nodules and cancer often affect women over 50 years old.Complications following thyroidectomy Patients feel discomfort with neck symptoms such as pain, stress, and pressure in their neck; stiffness in the shoulder; and limited shoulder and neck range of motion. The Deep Cervical Flexor (DCF) Training with Visual Pressure Biofeedback provides a better clinical improvement in terms of pain reduction, cervical flexion and extension ROM, DCF endurance, and Neck Disability Index score. The purpose of this study is to determine the effect of stabilizer pressure biofeedback on post thyroidectomy neck pain in postmenopausal women.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 15/09/2022
Actual trial start date
Anticipated date of last follow up 01/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 36
Recruitment status Active, not recruiting
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group active stretching exercises 3 sessions per week 6 weeks active stretching exercise for neck muscles all women will asked to perform 3 repetitions of each stretching exercise with a 15-second sustain at the end of the range, and then turn back to the neutral position, 3 times per day (morning, afternoon, and late afternoon) 18 Active-Treatment of Control Group
Experimental Group stabilizer pressure biofeedback 3 sessions per week 6 weeks deep neck flexor stabilizer biofeedback unit exercise 18
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
* women suffer from neck pain after thyroidectomy * their age range from 50-65 years * their BMI < 35 kg/m² * neck pain from any other condition * premature & surgical menopause Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 65 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 24/03/2021 Resarch Ethical Committee
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zayat St. BienElsarayat, Dokky, Giza Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain Neck pain disability scale NPDS before and after treatment program
Secondary Outcome range of motion digital geniometer before and after treatment program
Secondary Outcome muscular endurance stabilizer pressure biofeedback before and after treatment program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University hospitals El Kasr Al Ainy street Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
marian yousry abdou Al-mohawelat street, AlMatbaa,El-Haram Giza 12111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University 1 Gamaa street Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Afaf Mohamed Mahmoud botla El kanater el khairia Qaluobia 1122 Egypt
Elham Shahat Hassan Barshoom Al-Kobra,Toukh Qaluobia 13813 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marian Yousry Abdou Khalil marianyousry11@gmail.com 0201288866398 Almohawlat street,Al Matbaa,El Haram
City Postal code Country Position/Affiliation
Giza 12111 Egypt physical therapist in cairo univeristy hospitals
Role Name Email Phone Street address
Public Enquiries Afaf Mohamed mahmod drafafmohamed@yahoo.com 0201283126608 El kanater el khairia
City Postal code Country Position/Affiliation
Qaluobia 1122 Egypt faculty of physical therapy cairo univeristy
Role Name Email Phone Street address
Scientific Enquiries Elham Shahat Hassan elhamramadan70@cu.edu.eg 0201206146539 Barshoom Al-Kobra,Toukh
City Postal code Country Position/Affiliation
Qaluobia 13813 Egypt faculty of physicaltherapy cairo univeristy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in post-thyroidectomy neck pain. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e., a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Study Protocol Data requests can be submitted starting nine months after article publication, and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to a trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://bfpt.springeropen.com/ 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