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.: PACTR201811496048196 Date of Approval: 29/11/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title IMMEDIATE EFFECT OF SUSTAINED NATURAL APOPHYSEAL GLIDE ON BALANCE AND PAIN IN CHRONIC NON-SPECIFIC LOW BACK PAIN
Official scientific title Immediate effect of sustained natural apophyseal glide (SNAG) on balance and pain in chronic non-specific low back pain
Brief summary describing the background and objectives of the trial Background :The back region is an important part of the human body. It is formed of different anatomical structures and provides multiple functions. LBP, the worldwide health problem, may not only cause just simple pain that recovers with analgesics however it may cause balance problems that will definitely interfere with activities of daily living.The physical therapy field contains wide variety of traditional and recent approaches all of them directed to solve this heterogeneous problem despite none of those techniques can be said to be the most effective among others. One of the promising manual therapy techniques used successfully in the treatment of LBP is the Mulligan`s lumbar “SNAG”. Unfortunately, most of these promising results were depending on clinical observations and experience. Lack of research supporting these clinical findings encouraged many researchers to investigate different effects of SNAG on a variety of back conditions as LBP. And for the continuation of research this study is obtained for discovering more about the effects of low back pain and Mulligan’s lumber SNAG on LBP for better and more promising health life. Objective of trial :To investigate the immediate effect of the Mulligan’s lumbar “SNAG” on balance in patients with chronic nonspecific low back pain (CNSLBP)
Type of trial CCT
Acronym (If the trial has an acronym then please provide) SNAG
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 09/04/2018
Actual trial start date 09/04/2018
Anticipated date of last follow up 01/10/2018
Actual Last follow-up date 01/10/2018
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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 Non-randomised Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Immediate effect of SNAG 3 sets of 6 repetitions 15 mins Mulligan concept lumbar SNAG and Sham technique were performed by the same physical therapist. Eligibility test for SNAG treatment was determined by applying SNAG for 3 repetitions during the initial screening session; patients who experienced no worsening or showed improvement of pain and ROM were considered good candidates. The technique was considered safe for patients who did not have immediate improvement. If adverse effects resulted after the application of SNAG even of its direction, force, or handling, the patient would have been excluded from the study Mulligan SNAG technique for lumbar spine were applied for patient in the experimental group only. Participants were assuming stride standing. The therapist was standing behind the participant as described by Mulligan to support the patient during application of the technique and allow easy performance of the required movement.The therapist applied the mobilizing force parallel to the facet joint plane (cephalic direction) and over the spinous processes of the respective symptomatic spinal levels in a sustained manner over the spinous process while the patient performing flexion trunk flexion. Flexion position was maintained for few seconds then the participant returned to starting position while the therapist maintaining the mobilizing force. .Three sets of 6 repetitions were used in each lumbar spinal level. 15
Control Group sham comparator 3 sets of 6 repetitions 15 mins Sham SNAG mobilization is a Placebo technique were applied to the participants from stride standing. The therapist was standing behind the participant to support the participant during application of the technique and allow easy performance of the required movement then The therapist applied the mobilizing force parallel to the facet joint plane different direction other than that of mulligan group over the spinous processes of the respective symptomatic spinal levels in a sustained manner over the spinous process while the patient performing flexion trunk flexion. Three sets of 6 repetitions were used in each lumbar spinal level 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients suffering from continuous or intermittent pain for 3 months or more. • Pain with no obvious organic or pathological cause. • Patients were eligible to Mulligan SNAG • Back pain due to a definite cause such as: Radicular pain, disc herniation, spinal stenosis, serious spinal complications, arthritis, degenerative joint diseases, disk lesion, inflammation and facet joint disease. • Obese patients with body mass index (BMI) above 28 kg/m2, • pregnant females • Balance problems due to vestibular or visual systems • Patient who received physical therapy through the last 6 months Adult: 19 Year-44 Year 18 Year(s) 25 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 10/04/2018 Cairo university faculty of physical therapy research ethical committee
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Ad Doqi, Giza, Giza Governorate 11432 giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome investigating the immediate effect of mulligan SNAG technique on balance in patients with chronic non specific low back pain ,so i measured the postural stability through static balance of both limb stance and dynamic balance of both limb stance and other dynamic balance testing of single limb stance . 20 secs for each balance test
Secondary Outcome investigating the immediate effect of mulligan SNAG on pain intensity in patients with chronic non specific low back pain 20 sec pretesting and post testing
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Misr university for science and technology physical therapy out clinic souad kafafi street 6 october city 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki giza 11432 Egypt University
Secondary Sponsor Misr university for science and technology Al-Motamayez District 6th october city Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Neveen Abdellatif Abdel Raoof 20 Eid Mostafa St. Giza 11432 Egypt
Dr.Hisham Mohamed Abdel Raheem Hussien 1st district 6th october 6th october 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amal abdel baky amal.morsi@must.edu.eg +201111102279 376 ahmed hamdy st. motamayz district
City Postal code Country Position/Affiliation
6th october 11432 Egypt demonstrator in faculty of physical therapy basic science department Misr university for science and technology
Role Name Email Phone Street address
Public Enquiries neveen abdel raoof nevein.abdellatif@pt.cu.edu.eg +201064615553 20 Eid Mostafa St.
City Postal code Country Position/Affiliation
Giza 111432 Egypt vice dean faculty of physical therapy Cairo university
Role Name Email Phone Street address
Scientific Enquiries Hisham Hussien drhisham3000@yahoo.com +201020936303 18 1st district
City Postal code Country Position/Affiliation
6th october 111432 Egypt lecturer of physical therapy basic science department Cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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