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.: PACTR202201807752672 Date of Approval: 11/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The influence of neurodynamic median nerve mobilization techniques on pain, grip strength, and function in women with bilateral carpal tunnel syndrome
Official scientific title The influence of neurodynamic median nerve mobilization techniques on pain, grip strength, and function in women with bilateral carpal tunnel syndrome. A single-blind randomized controlled trial.
Brief summary describing the background and objectives of the trial The effectiveness of neurodynamic median nerve mobilization techniques on pain, grip strength, and upper limb function has been the subject of several previous studies. This technique has often been studied in combination with conservative or physiotherapeutic treatment. However, no previous study has attempted to assess the effectiveness of this technique in Africa. The aims of this study are to evaluate the effectiveness of this technique on pain, grip strength, and functional status in women with bilateral carpal tunnel syndrome.
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 04/03/2019
Actual trial start date 04/03/2019
Anticipated date of last follow up 09/11/2020
Actual Last follow-up date 14/12/2020
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 124
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Neurodynamic mobilization of the median nerve 20 sessions (2 sessions per week) 10 weeks The intervention was made by a neurodynamic mobilization by sliding the median nerve between the wrist and the elbow so that when the joint position of one joint increases the nerve tension the other relaxes it and alternates after the previous joint positions. Concretely, we slid the nerve distally by an extension of the wrist and flexion of the elbow simultaneously and alternate by flexion of the wrist and an extension of the elbow for the proximal sliding of the median nerve and this for 45 repetitions for each series for three series. We gave the patient a minute of rest between every two series. After 15 sessions of sliding the median nerve between the wrist and the elbow, we transitioned to mobilization with the tension of the median nerve and in this case, we mobilized the wrist from flexion to extension while the elbow was held in extension and the other joints in the same position of the ULNT1 test described by Butler in 1991. 62
Control Group Placebo mobilization of the elbow and the wrist 20 sessions (2 per week) 10 weeks The control was done by a joint mobilization not requesting the median nerve as a placebo treatment. This mobilization was to hold the wrist in permanent palmar flexion and to mobilize the elbow from flexion to extension for 45 repetitions, for 3 sets and one-minute rest was given to the patient between every two sets. The other joints were maintained in the same position of the ULNT1 described by Butler in 1991. 62 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Aged more than 18 and diagnosed bilateral carpal tunnel syndrome on the base of nerve conduction studies by a neurologist. A patient diagnosed with SCC already operated; Patient diagnosed with SCC following conservative treatment; Patient diagnosed with SCC presenting with systemic disease; Patient diagnosed with SCC presenting with degenerative joint injury to the upper limbs; Pregnant women diagnosed with SCC Patient diagnosed with SCC presenting with a musculoskeletal lesion in the upper limbs; Patients diagnosed with SCC refusing to be part of the study 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 20/12/2018 CERB Rabat
Ethics Committee Address
Street address City Postal code Country
Souissi Rabat 10000 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain, using visual analogic scale. Before treatement, after 10 sessions and after 20 sessions of treatement.
Primary Outcome Grip strength using a JAMAR Plus Dynamometer Before treatement, after 10 sessions and after 20 sessions
Primary Outcome Functional status using Boston Carpal Tunnel Syndrome questionnaire Before treatement, after 10 session and after 20 sessions
Secondary Outcome Comparison of the results between intervention group and control group concerning Pain, Grip strength and functional status Before treatement, after 10 sessions and after 20 sessions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Neurophysiology departement of Rabat Speciality Hospital Souissi Rabat 10000 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
Hassan BEDDAA 210, J5 AMAL 1 Rabat 10053 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor BEDDAA Hassan 210, J5 AMAL 1 CYM Rabat 10053 Morocco Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hassan BEDDAA hassanbeddaa@gmail.com 212669781658 210, J5 AMAL 1 CYM
City Postal code Country Position/Affiliation
Rabat 10053 Morocco PhD Student at Mohamed 5th University
Role Name Email Phone Street address
Scientific Enquiries NAZHA BIROUK nazha.birouk@gmail.com 212661216327 Souissi
City Postal code Country Position/Affiliation
Rabat 10000 Morocco Professor at Mohamed 5th University and neurologist at Neurophysiologie departement of Rabat specialty hospital
Role Name Email Phone Street address
Public Enquiries Abdelghafour MARFAK ab.marfak@gmail.com 212678344278 Souissi
City Postal code Country Position/Affiliation
Rabat 10000 Morocco National School of Public Health Rabat
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Data are available indefinitely at (Link to be included) 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