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.: PACTR201812663422445 Date of Approval: 12/12/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title effect of cupping combined with neural mobilization in patients with sciatica
Official scientific title Electroneurographic response to cupping combined with neural mobilization in Patients with discogenic sciatica
Brief summary describing the background and objectives of the trial Discogenic sciatica (LBP) remains the second most common symptom-related reason for seeing a physician in the United States. Of the US population, 85% will experience an episode of mechanical LBP at some point during their lifetime. Fortunately, the LBP resolves for the vast majority within 2-4 weeks (Canale and Beaty, 2012). For individuals younger than 45 years, mechanical LBP represents the most common cause of disability and is generally associated with a work-related injury. For individuals older than 45 years, mechanical LBP is the third most common cause of disability, and a careful history and physical examination are vital to evaluation, treatment, and management (Goodman and Fuller, 2011). Because there were few researches available for cupping and nearly there is no researches that combine cupping and neural mobilization, so this study was done to answer the following questions: a) Does passive neurodynamic mobilization program have statistically significant effect in treatment of patients with discogenic sciatica? b) Does traditional cupping therapy have statistically significant effect in treatment of patients with discogenic sciatica? c) Does passive neurodynamic mobilization added cupping therapy have statistically significant effect in treatment of patients with discogenic sciatica? d) Are there any statistically significant difference between passive neurodynamic mobilization program, traditional cupping therapy and passive neurodynamic mobilization added cupping therapy in treatment of patients with discogenic sciatica? This study will conducted to investigate and compare the effect of passive neurodynamic mobilization program, traditional cupping therapy and passive neurodynamic mobilization added cupping therapy in treatment of patients with discogenic sciatica
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Discogenic sciatica
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 28/04/2018
Actual trial start date
Anticipated date of last follow up 01/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group passive neurodynamic mobilization one session The mobilization will be maintained for 30 sec then rest for 30 sec then repeat 5 times for 5 sets It is a passive technique used to mobilize common peroneal nerve and tibial nerve via applying straight spinal lateral flexion to contralateral side (towel under waist), leg raising, hip adduction, medial rotation and knee extension while patient is side lying, and the treated limb is the upper limb. Therapist is standing in front of the patient to save therapist¿s power. 15
Control Group cupping one session 20 min Patients in the intervention group will receive a single session of wet cupping intervention. Cupping will be performed by expert certified physicians, who regularly perform cupping in the clinical setting. The patient will assume a prone lying position according to the affected site fully exploring the positions for bloodletting. The cupping will be applied to the related points for 5-10 minutes. 15 Active-Treatment of Control Group
Experimental Group cupping added neural mobilization one session 60 min Every cup is applied separately, while applying passive neurodynamic mobilization over sciatic nerve with its two branches (tibial and common peroneal nerve) in the time at which the blood is letting. The patient will assume a side lying position according to the affected site fully exploring each position for bloodletting sequentially. The cupping will be applied to only one point per time 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Body mass index less than 35. ¿ Back and leg pain with duration of at least three months ago. ¿ Confirming disc with MRI or CT. ¿ Discogenic sciatica between L4-L5 with radiation of sciatic nerve. ¿ Pain is limiting hip flexion ROM with knee extension. ¿ Low back pain without sciatica. ¿ Diabetic patient. ¿ Patient with any surgical procedures. ¿ Pregnant woman. ¿ Patients with deformity of the spine and lower limb. ¿ Unconsciousness or inability to be ambulant. ¿ Pain less than 3 months. ¿ History of epilepsy. ¿ Piriformis syndrome (fair test). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 35 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
Yes 08/02/2018 ethics commetee of physical therapy faculty
Ethics Committee Address
Street address City Postal code Country
El zayat street Doki cairo 11731 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome nerve conduction studies (f wave and h reflex) for sound and affected side at the baseline and immediately after the treatment
Secondary Outcome Algometery for sound and affected side at the baseline and immediately after the treatment and after 1 week and after 1 month
Secondary Outcome rang of motion by electrogoniometer for sound and affected side at the baseline and immediately after the treatment and after 1 week and after 1 month
Secondary Outcome Disability by Modified oswestry disability questionnaire for sound and affected side at the baseline and immediately after the treatment and after 1 week and after 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Kafrelseik university El zayat street Kafrelseik 000000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Ali Torad Not available cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy cairo university El zayat street cairo 000000 Egypt University
Secondary Sponsor Kafr elsheik university El-Gam3a Street Kafr El Sheik 000000 Egypt University
COLLABORATORS
Name Street address City Postal code Country
prof Dr Amir Mohamed Saleh al obour Al3bour city 000000 Egypt
Assist Prof Dr Yasser Aneis faysal giza 000000 Egypt
Prof Dr Amr Abdullah 22 abdallah Helwan 11421 Egypt
Assist Prof Dr Amr Abo Gazia El-Gam3a Street Kafr El Sheik 000000 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ahmed torad ahmed.ali.torad@gmail.com 00201112486424 Ali Amin street
City Postal code Country Position/Affiliation
nasr city 0000 Egypt lecturer assisstant at faculty of physical therapy Kafrelseik university
Role Name Email Phone Street address
Public Enquiries ahmed torad ahmed.ali.torad@gmail.com 00201008889975 Ali Amin street
City Postal code Country Position/Affiliation
nasr city 0000 Egypt lecturer assisstant at faculty of physical therapy Kafrelseik university
Role Name Email Phone Street address
Scientific Enquiries ahmed torad ahmed.ali.torad@gmail.com 00201116811808 Ali Amin street
City Postal code Country Position/Affiliation
nasr city 0000 Egypt lecturer assisstant at faculty of physical therapy Kafrelseik university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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