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.: PACTR201611001851413 Date of Approval: 05/11/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Neurophysiological and Biomechanical Effect of Spinal Mobilization with Arm Movement in Cervical Radiculopathy: Randomized Controlled Trial
Official scientific title Effect of spinal mobilization with arm movement on dermatomal somatosensory, pain, proprioception, range of motion and function in cervical radiculopathy
Brief summary describing the background and objectives of the trial Cervical radiculopathy (CR) is a common neuromusculoskeletal disorder which lead to a significant reduction in health related quality of life.Spinal mobilization with arm movement is one of Mulligan techniques used to reduce nerve mechanosensitivity, restore function and resolve symptoms. Mulligan purported a biomechanical basis for the efficacy of MWM in reducing pain and improving ROM, but there may be other explanations for their effects including neurophysiologic mechanisms. Cervical mobilization with arm movement has therefore been chosen as the focus of this study with the expectation that an enhanced understanding of its neurophysiological, biological and biomechanical effects may stimulate informed discussion about the proper treatment plan when dealing with patients suffers from cervical radiculopathy. Purpose of the study: To determine the effect of spinal mobilization with arm movement on the amplitude and latency of dermatomal somatosensory evoked potential, neck pain, functional performance, ROM and proprioception in patient with cervical radiculopathy. A pilot study will be conducted to detect the sample size. The patients of both gender with chronic CR will participate in the study with age ranging from 30 to 50 years old. The patients will be assigned randomly into two equal group A&B. Dermatomal somatosensory evoked potential for level C5-6, C6-7, and C7-8 will be assessed, pain will be assesed by VAS, functional disability will be assesed by NDI, ROM and neck proprioception will be assesed by CROM.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SMWAM MWM ROM
Disease(s) or condition(s) being studied cervical radiculopathy,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 04/12/2016
Actual trial start date
Anticipated date of last follow up 05/02/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Not yet 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised The patients were assigned randomly by random generator and by using permuted blocks of different sizes which was done by third person into two equal group A and B The allocation will be determined by a third person (the holder of the sequence who is situated off site) Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group traditional program for cervical radiculopathy 12 sessions, session each other day 1 month hot pad over cervical area for 20 minutes, active Range of motion, stretching and isometric strengthening deep neck flexors 40
Experimental Group spinal mobilization with arm movement 12 sessions, session each other day 1 month hot pad over cervical area for 20 minutes, active Range of motion, stretching and isometric strengthening deep neck flexors, and spinal mobilization with arm movement to the affected level 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. All patients suffer from cervical radiculopathy of lower cervical spine(C5-C6 and/ or C6-C7) as confirmed with MRI (Young etal., 2009). 2. The patient has to get ;positive sign in at least 3 out of the following testing (1- cervical distraction test, 2- upper limb tension test (ULTT), 3- Spurling test, and 4- ipsilateral cervical rotation reduced by more than 60°) (Straus et al., 2005) 3. Duration of symptoms more than 3 months to avoid acute stage of inflammation. 4. Pain is radiated in lateral aspect of arm and forearm 1. Posterior osteophytes 2. Spinal canal stenosis 3. Rheumatoid arthritis 4. Vestibular insufficiency 5. Vertebrobasilar insufficiency 6. Osteoprosis 7. Any signs or symptoms of mylopathy 8. Any abnormalities of deep sensation 9. Associated pathologies of upper cervical region or the upper limb that may cause overlapping with clinical findings as referred pain from costotransverse joint, rotator cuff tendonitis, cervical rib syndrome and entrapment neuropathy (Donald, 2000) 30 Year(s) 50 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
No 13/11/2016 faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
giza Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 13/11/2016 faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zyad street, Dooki, Giza , Egypt giza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The peak amplitude and latency of dermatomal somatosensory evoked potential before treatment and after completion of the sessions.
Primary Outcome cervical proprioception before treatment and after completion of the sessions.
Secondary Outcome neck pain before treatment and after completion of the sessions.
Secondary Outcome cervical range of motion before treatment and after completion of the sessions.
Secondary Outcome functional performance before treatment and after completion of the sessions.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
the clinic of faculty of physical therapy 7 Ahmed El Zayad street, Dooki , Giza , Egypt giza Egypt
the clinic of El-Qasr El Einy hospital. El- Qasr el Einy street, Giza, Egypt giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university University
Primary Sponsor faculty of physical therapy 7 Ahmed el zayad street, Dooki giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
DR. Fatma seddik 9 Dr. Mostafa Mosharafa street, El Maboossein city Giza Egypt
DR. Soheir Shehata 11 Ahmed El taieb street, Saint Treize, Shoupra Cairo Egypt
Dr. Ahmed Azzam 8 El tal street, el Warak Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator soheir shehata karasameh@gmail.com 01222968728 11 El Tayeb Street, Saint treize, Shoupra
City Postal code Country Position/Affiliation
cairo Egypt
Role Name Email Phone Street address
Public Enquiries sameh senyout karasameh@gmail.com 01224071673 8 abd Rabo Street, El Qawmeia
City Postal code Country Position/Affiliation
Giza Egypt
Role Name Email Phone Street address
Scientific Enquiries soheir shehata soheirsamaan@yahoo.com 01222968728 11 El Tayeb Street, Saint treize, Shoupra
City Postal code Country Position/Affiliation
cairo Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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