Cervical RadiculopathySNAG&MCTNCT03362567
Sustained Natural Apophyseal Glides and Mechanical Cervical Traction in the Management of Cervical Radiculopathy
A study testing Sustained Natural Apophyseal Glides and Mechanical Cervical Traction in people with Cervical Radiculopathy, run by Obafemi Awolowo University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Sustained Natural Apophyseal Glides and Mechanical Cervical Traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2016to 15 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
-
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervical Radiculopathy
- Being tested
- Sustained Natural Apophyseal Glides, Mechanical Cervical Traction
- Keywords
- Cervical Radiculopathy, Sustained Natural Apophyseal Glides, Mechanical Cervical Traction, Pain Intensity, Neck Disability
- Medical subject headings
- Radiculopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained Natural Apophyseal GlidesOther
Also called SNAGS
Subjects in SNAGS group were treated with sustained natural apophyseal glides, twice weekly for six weeks
Mechanical Cervical TractionOther
Also called MCT
subjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks
| Study group | Role | What they receive |
|---|---|---|
| SNAGS Group | Experimental | Subjects in SNAGS group were treated with application of sustained natural apophyseal glides, twice weekly for six weeks Receives: Other: Sustained Natural Apophyseal Glides; Other: Mechanical Cervical Traction |
| MCT Group | Experimental | subjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks Receives: Other: Sustained Natural Apophyseal Glides; Other: Mechanical Cervical Traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
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
Measured: 6 weeks
Secondary outcomes (1)
Neck disability index
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start28 Jul 2016
- Primary completion15 Apr 2017
- Study completion15 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study involved 47 patients with cervical radiculopathy which were purposively recruited from the Physiotherapy Department Outpatient Clinic of Usmanu Danfodio University Teaching Hospital, Sokoto for the study. Subjects were randomly allocated to Sustained Natural Apophyseal Glides (SNAGS)and Mechanical Cervical Traction (MCT) group. All the subjects were treated using cryotherapy for seven minutes. Subjects in SNAGS group were then treated with sustained natural apophyseal glides, twice weekly for six weeks while subjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks. Visual analogue scale, neck disability index questionnaires and inclinometer were used to assess pain intensity, disability and cervical range of motion respectively at the beginning, 3rd and 6th week of treatment
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adesola Ojo Ojoawo, Obafemi Awolowo University
- Investigators
- Adesola O Ojoawo, Phd, Principal investigator, Obafemi Awolowo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362567
- Sponsor's protocol ID
- IPHOAU/12/673
- Acronym
- SNAG&MCT
- Status last verified
- Dec 2017
- First submitted
- 28 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ali A, Shakil-Ur-Rehman S, Sibtain F. The efficacy of Sustained Natural Apophyseal Glides with and without Isometric Exercise Training in Non-specific Neck Pain. Pak J Med Sci. 2014 Jul;30(4):872-4.
PubMed 25097535
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Sustained Natural Apophyseal Glides and Mechanical Cervical Traction in the Management of Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT03362567
- Acronym / sponsor ID
- SNAG&MCT / IPHOAU/12/673
- Conditions
- Cervical Radiculopathy
- Keywords
- Cervical Radiculopathy, Sustained Natural Apophyseal Glides, Mechanical Cervical Traction, Pain Intensity, Neck Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Obafemi Awolowo UniversityUniversity, hospital or other
- Study start
- 28 Jul 2016 (actual)
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study involved 47 patients with cervical radiculopathy which were purposively recruited from the Physiotherapy Department Outpatient Clinic of Usmanu Danfodio University Teaching Hospital, Sokoto for the study. Subjects were randomly allocated to Sustained Natural Apophyseal Glides (SNAGS)and Mechanical Cervical Traction (MCT) group. All the subjects were treated using cryotherapy for seven minutes. Subjects in SNAGS group were then treated with sustained natural apophyseal glides, twice weekly for six weeks while subjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks. Visual analogue scale, neck disability index questionnaires and inclinometer were used to assess pain intensity, disability and cervical range of motion respectively at the beginning, 3rd and 6th week of treatment
| Arm | Type | Receives |
|---|---|---|
| SNAGS Group | Experimental | Other: Sustained Natural Apophyseal Glides, Other: Mechanical Cervical TractionSubjects in SNAGS group were treated with application of sustained natural apophyseal glides, twice weekly for six weeks |
| MCT Group | Experimental | Other: Sustained Natural Apophyseal Glides, Other: Mechanical Cervical Tractionsubjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustained Natural Apophyseal GlidesAlso: SNAGSSubjects in SNAGS group were treated with sustained natural apophyseal glides, twice weekly for six weeks | Other | MCT Group, SNAGS Group |
| Mechanical Cervical TractionAlso: MCTsubjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks | Other | MCT Group, SNAGS Group |
Primary outcome
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
1 secondary outcome
Neck disability index
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Background: PubMed 25097535Ali A, Shakil-Ur-Rehman S, Sibtain F. The efficacy of Sustained Natural Apophyseal Glides with and without Isometric Exercise Training in Non-specific Neck Pain. Pak J Med Sci. 2014 Jul;30(4):872-4.
Related trials for Cervical Radiculopathy
Recruiting
Ultrasound-Guided Electrical Dry Needling for Chronic Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Recruiting
Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
RecruitingObservational study
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Cervical Radiculopathy, Cervical Myelomalacia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adesola O Ojoawo, Phd principal investigator
Obafemi Awolowo University
Questions about this trial
What is this clinical trial studying?
A study testing Sustained Natural Apophyseal Glides and Mechanical Cervical Traction in people with Cervical Radiculopathy, run by Obafemi Awolowo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03362567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.