Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001298505
Ethics application status
Approved
Date submitted
26/08/2015
Date registered
27/11/2015
Date last updated
24/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Mulligan`s lumbar “SNAG” on chronic non-specific low back pain
Scientific title
Effect of Mulligan`s lumbar "SNAG" on proprioception, pain, range of Motion and functional level in chronic non-specific low back pain patients
Secondary ID [1] 287356 0
NIL
Universal Trial Number (UTN)
U1111-1173-6848
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic non-specific low back pain 296017 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296298 296298 0 0
Physiotherapy
Musculoskeletal 296941 296941 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1- standard physiotherapy (including infrared heating of the low back for 15 minutes, stretching exercises for back, hamstrings, iliopsoas muscles - 3 repetitions X 30 seconds hold X 30 seconds rest , strengthening exercises for abdominal muscles 1 set X 10 repetitions X 5 seconds hold.
- frequency of standard treatment sessions: 3 x 40 minutes per week for 4 weeks.
- (estimated total session duration is: 40 mins,
2- "SNAG" Mulligan technique applied from setting position on the L4, and L5 spinous processes in a cephalic direction for 3 sets X 5 repetitions (for about 10 mins / session . 3 session /week for 4 weeks). SNAG technique will be applied by physiotherapist.
- SNAG will be applied at the end of the session for the study group only (the total study group session time will be 50 mins. (the 10 minutes lack in control group session time will be filled with examination and history talking to achieve equality in time involved in patients treatment and caring)
Note: first program will be introduced to the control group, the first and second program will be both introduced to the experimental (study) group
Intervention code [1] 292694 0
Treatment: Other
Intervention code [2] 292695 0
Rehabilitation
Comparator / control treatment
standard physiotherapy treatment:including infrared heating of the low back for 15 minutes, stretching exercises for back, hamstrings, iliopsoas muscles - 3 repetitions X 30 seconds hold X 30 seconds rest , strengthening exercises for abdominal muscles 1 set X 10 repetitions X 5 seconds hold.
total session time is 40 mins (plus 10 minutes for history taking and talking with the patient and preparation to assure spending the same time in both control and study groups patients)
3 sessions per week for 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 295952 0
lumbar spine proprioception in the form of measuring the repositioning accuracy
Timepoint [1] 295952 0
before and immediately after the end of one month of treatment application
measured by Biodex System 3 Pro Isokinetic Dynamometer (Biodex Medical Inc., Shirley, New York, USA).
Secondary outcome [1] 317013 0
pain level measured by non-numerical 100mm VAS
Timepoint [1] 317013 0
before and immediately after the end of the one month of treatment application
Secondary outcome [2] 317014 0
range of movement of the lumbar spine : flexion and extension
will be measured by inclinometer
Timepoint [2] 317014 0
immediately after the end of the last session of the one month treatment application (after the 12th session)
Secondary outcome [3] 317015 0
functional level
Timepoint [3] 317015 0
Oswestry Disability Index
before and immediately after the end of one month of the treatment application

Eligibility
Key inclusion criteria
1- patients diagnosed (by physician) with chronic non-specific low back pain.
2- signs and symptoms lasts more than 3 months.
3- patient must be able to assume at least more than 30 degrees of trunk flexion to be able to perform the task required for repositioning accuracy on the isokinetic machine.
4- patients with moderate Oswestry Disability Index results only will be included.
Minimum age
17 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- Any low back pain due to a definite cause as; arthritis, degenerative joint diseases, disc lesion, inflammation and facet joint disease.
2- Patients with a history of head trauma or other neurological manifestations.
3- Obese patients with body mass index (BMI) above 25, and pregnant females.
4- Any patients having the common contraindications for manual therapy as joint hyperlaxity, instability, acute infection.
5-Severe disabling LBP.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
the included subjects will be selected systematically from a list of the patients attending the faculty of physical therapy out-patient clinic, Cairo, Egypt.
after applying the initial assessment and signing the informed consent, each subject will be asked to pick a closed envelop containing a numbered card. this number will determines if the subject will be in the control or the study groups
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
the number of the sample will be based on the results of a pilot study of five patients before starting the actual study. this is because there are no previous study on the effects of the SNAG on lumbar proprioception
power: 80%
significance level: .95%

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2015
Date of last participant enrolment
Anticipated
30/03/2016
Actual
29/12/2015
Date of last data collection
Anticipated
Actual
30/01/2016
Sample size
Target
40
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 7296 0
Egypt
State/province [1] 7296 0
Cairo

Funding & Sponsors
Funding source category [1] 291915 0
Self funded/Unfunded
Name [1] 291915 0
Hisham Mohamed AbdelRaheem Hussien (the main researcher)
Country [1] 291915 0
Egypt
Primary sponsor type
Individual
Name
Hisham Mohamed AbdelRaheem Hussien
Address
Egypt - AlGiza - 6th Ahmed Elsayat street - Faculty of Physical Therapy- Cairo University.
postal code 12611
Country
Egypt
Secondary sponsor category [1] 290585 0
None
Name [1] 290585 0
Address [1] 290585 0
Country [1] 290585 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293421 0
Ethical comitte of faculty of physical therapy cairo university
Ethics committee address [1] 293421 0
Ethics committee country [1] 293421 0
Egypt
Date submitted for ethics approval [1] 293421 0
17/04/2014
Approval date [1] 293421 0
20/04/2015
Ethics approval number [1] 293421 0
P.T.REC/012/00861

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59866 0
Mr Hisham Mohamed Abdel_raheem Hussien
Address 59866 0
Faculty of Physical Therapy, Cairo University, Basic Science Department
Egypt - Al-Giza - Bein Elsarayat - 6th Ahmad Elzayat street.
post code : 12211
Country 59866 0
Egypt
Phone 59866 0
+2 01020936303
Fax 59866 0
Email 59866 0
[email protected]
Contact person for public queries
Name 59867 0
Ebrahim Mostafa
Address 59867 0
Faculty of Physical Therapy, Cairo University, basic Science Department,
Egypt - Al-Giza -Bein Elsarayat - 6th Ahmad Elzyat st.
post code : 12211
Country 59867 0
Egypt
Phone 59867 0
+2 01227022334
Fax 59867 0
Email 59867 0
[email protected]
Contact person for scientific queries
Name 59868 0
Omaima Kattabei
Address 59868 0
Faculty of Physical Therapy, Cairo University, basic Science Department,
Egypt - Al-Giza -Bein elsarayat- 6th Ahmad Elzyat st.
post code : 12211
Country 59868 0
Egypt
Phone 59868 0
+20 1222194545
Fax 59868 0
Email 59868 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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