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CompletedNCT03362567SNAG&MCTUpdated Dec 5, 2017

Sustained Natural Apophyseal Glides and Mechanical Cervical Traction in the Management of Cervical Radiculopathy

An interventional study of Sustained Natural Apophyseal Glides and Mechanical Cervical Traction in Cervical Radiculopathy, sponsored by Obafemi Awolowo University. Completed. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-05.

Sponsored by Obafemi Awolowo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
25 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cervical Radiculopathy

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Keywords

  • Cervical Radiculopathy
  • Sustained Natural Apophyseal Glides
  • Mechanical Cervical Traction
  • Pain Intensity
  • Neck Disability
03

Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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

-

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    SNAGS Group

    Subjects in SNAGS group were treated with application of sustained natural apophyseal glides, twice weekly for six weeks

    Other: Sustained Natural Apophyseal Glides · Other: Mechanical Cervical Traction

  • Experimental
    MCT Group

    subjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks

    Other: Sustained Natural Apophyseal Glides · Other: Mechanical Cervical Traction

Interventions

  • OtherSustained Natural Apophyseal Glides

    Subjects in SNAGS group were treated with sustained natural apophyseal glides, twice weekly for six weeks

    Also known as: SNAGS

  • OtherMechanical Cervical Traction

    subjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks

    Also known as: MCT

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 6 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

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 ↗
08

Registry details

Key details

Study ID
NCT03362567
Lead sponsor
Obafemi Awolowo University
Responsible party
Adesola Ojo Ojoawo (Dr and Senior Lecturer, Obafemi Awolowo University) — Principal investigator
First posted
Dec 5, 2017
Start date
Jul 28, 2016
Primary completion
Apr 15, 2017
Completion
Apr 15, 2017
Last update
Dec 5, 2017

Study contacts

Adesola O Ojoawo, Phd
principal investigator · Obafemi Awolowo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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