- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03362567
Sustained Natural Apophyseal Glides and Mechanical Cervical Traction in the Management of Cervical Radiculopathy (SNAG&MCT)
December 4, 2017 updated by: Adesola Ojo Ojoawo, Obafemi Awolowo University
Comparative Effects of Sustained Natural Apophyseal Glides and Mechanical Cervical Traction in the Management of Cervical Radiculopathy
Sustained natural apophyseal glides (SNAGS), is a form of manual therapy, involved a combination of a sustained facet glide with active motion, followed by overpressure.
Natural apophseal glides (NAGS), a modification of SNAGS, involves a mid to end-range facet joint mobilisation applied anterocranially or posterioanteriorly along the plane of treatment, combined with a small amount of manual traction which increases movement within the spine, and decreases symptomatic pain .
A study reported that Natural Apophyseal Glides (NAGS) and Sustained Natural Apophyseal Glides (SNAGS) demonstrated significant effects in reducing pain and disability in subjects with chronic neck pain .
This technique, SNAGS, is however an evolving manual therapy techniques which its effectiveness has not been thoroughly investigated in cervical radiculopathy treatment raised author's curiosity to compare and document efficacy of SNAGS with cervical traction in Nigeria since comparative studies evaluating SNAGS and manual cervical traction relative efficacies among Nigerians are yet to be documented if at all available.
Consequently, the quest is to look for a quicker and a better way of relieving cervical radiculopathy in this environment .
The more reason why we have to compare it with a conventional mechanical traction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a Quasi experimental study.
Participants will be patients with radiculopathy receiving treatment at the Usman Danfodio University Teaching Hospital Sokoto Nigeria.
Ethical approval will be obtained from Institute of Public Health of the Obafemi Awolowo University Ile-Ife, Nigeria, and a copy will be taken to the site of the study.
The purpose and protocol for the study will be explained to the participants, after their informed consent have been obtained.
The sample size will be determined using N= 4σ2 (Zcrit+Zpwr)2/ D2 where N is the total sample size, σ is the assumed SD of each group (assumed to be equal for the groups), which is assumed to be 16.63 from previous study; Zcrit is the standard normal deviate corresponding to the selected significance criterion, i.e 0.05(95% = 1,960), Zpwr is the standard normal deviate corresponding to the selected statistical power (i.e.
0.80 = 0.842), and D is the minimum expected difference among the three means, and D =18 from a previous study.
Therefore, N obtained will be 41.22.
Fifty two participants are proposed for this study (making 26 participants for each group) in order to give room for attrition.
The 52 participants will be allocated to two groups (Groups A and B) using permuted block randomization.
Subjects in group A will receive (i) Sustained Natural Apophyzeal Glides: Each subject in this group will be in sitting position facing the wall bar.
The therapist will place on thumb reinforced over the spinous process of the implicated cervical vertebra.
The therapist will then push upon the implicated spinous process.
The pressure will be sustained for 60 seconds.
Six repetitions will be carried out and maintained on each visit twice in a week for 6 weeks.
Subjects in group B will receive over -the -door mechanical cervical traction in sitting position using position 10% of each patient's body weight for 15 minutes on each visit, twice in a week for 6 weeks.
Pain intensity will be measured using visual analogue scale, cervical range of motions will be measured using inclinometer, functional disabilities will be measured using neck disabilities index questionnaires.
The out come measures will be applied three times: pre-treatment, 3rd week and 6th week within the treatment period.
The data obtained will be analysed using descriptive and inferential statistics.
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria: Subjects diagnosed with neck pain of mechanical origin of not less than 3 months. Subjects without pathology affecting the neck and upper limb(s).
-
Exclusion Criteria:(i) Participants with history of vertebro-basilary artery insufficiency. Patient with history of cervical surgery or arthroplasty
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SNAGS Group
Subjects in SNAGS group were treated with application of sustained natural apophyseal glides, twice weekly for six weeks
|
Subjects in SNAGS group were treated with sustained natural apophyseal glides, twice weekly for six weeks
Other Names:
subjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks
Other Names:
|
Experimental: MCT Group
subjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks
|
Subjects in SNAGS group were treated with sustained natural apophyseal glides, twice weekly for six weeks
Other Names:
subjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale
Time Frame: 6 weeks
|
Visual analogue scale is a scale with 10 points indicating the severity of pain.
o indicate no pain and 10 indicate excruciating pain.
5 indicate moderate pain.
Patient is asked to point to the scale indicating the perception of his or her pain intensity
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck disability index
Time Frame: 6 weeks
|
It has 10 sections with 5 questions on each section asking patient on what he can do.
Patient circles one choice that is most appropriate to him.
These are added together and percentage are found.
If 9 are filled out of 10 it will be 9 multiplied by 5 making 45.
The total score divided by 45 multiply by 100 will be the percentage of disability.
If the percentage is high, the disability is high and if the percentage is low the disability is low
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adesola O Ojoawo, Phd, Obafemi Awolowo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 28, 2016
Primary Completion (Actual)
April 15, 2017
Study Completion (Actual)
April 15, 2017
Study Registration Dates
First Submitted
November 28, 2017
First Submitted That Met QC Criteria
December 4, 2017
First Posted (Actual)
December 5, 2017
Study Record Updates
Last Update Posted (Actual)
December 5, 2017
Last Update Submitted That Met QC Criteria
December 4, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPHOAU/12/673
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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