SNAGs in Mechanical Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound Therapy, SNAGs
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
Inclusion criteria
- Age group between 20- 45 years.
- Both Gender male and female.
- Individuals having localized pain or stiffness in spine or both combined b/w C3 to C7 without upper limbs radiculopathy.
- Pain reported on VAS score ˃3 in neck region.
- Patients agree to sign written consent form.
Exclusion Criteria Patients were excluded if they were diagnosed with following conditions for ˃6 months:
- T.B, carcinoma, heart disease, osteoporosis.
- Neural disorders due to PIVD.
- Any trauma or localized infection in neck region.
- Upper MND, cervical stenosis, metabolic diseases in bone and joint.
- Hyper flexibility
- Open sores,
- Ongoing radiotherapy, chemotherapy, steroid therapy or anticoagulants.
- Psychiatric diseases such as phobia/obsession, depression.
- Allergy to hot pack
- Patients with history of surgery in cervical spine region with in a year.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mean and standard deviations of age and height between group A and B
Between group comparison of VAS, NDI and ROM
Arm Description
100 subjects with a mean age of 30.82±6.75 (group A, 31.42±6.67; group B, 30.82±6.82) ranging from 20 to 45 years, with a mean height of 165.52±7.85 (group A, 164.92±7.79; group B, 166.12±7.87) centimeters
VAS, NDI and Neck ROM between two groups were compared at pretest (0 day) and posttest (end of two weeks)
Outcomes
Primary Outcome Measures
Visual analog scale
Visual analog scale is a subjective outcome measurement where patients judge the intensity of their pain on a scale of 0-10, which is in the form of a 10cm straight line. On this 0-10 scale, zero denotes no pain and ten denotes severe pain intensity.
Neck Range of motion
Range of motion of the cervical spine measured by bubble inclinometer. It consists of a 360-degree scale with a fluid filled circular tube containing a small air bubble. It is a gravity dependent Goniometer, which uses the gravity's effect on fluid level to measure joint position and motion.
Secondary Outcome Measures
Neck disability Index
Neck disability Index contains 10 items, seven related to activities of daily living, two related to pain, and one item related to concentration. Each item is scored ranging from 0 (no pain or disability) to 5 (severe pain and disability); and the total score is expressed as a percentage, with higher scores corresponding to greater disability.
Full Information
NCT ID
NCT04617288
First Posted
October 30, 2020
Last Updated
November 5, 2020
Sponsor
Raj Nursing and Paramedical College
1. Study Identification
Unique Protocol Identification Number
NCT04617288
Brief Title
SNAGs in Mechanical Neck Pain
Official Title
Efficacy of SNAGs in the Management of Mechanical Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 10, 2015 (Actual)
Primary Completion Date
August 25, 2015 (Actual)
Study Completion Date
August 25, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Raj Nursing and Paramedical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neck pain is second largest cause of disability worldwide. Chronic neck pain prevalence is 14% which is somewhat higher in females as compared to males. In India reported prevalence is 6%. Therapeutically, neck pain is managed by physiotherapists using rest, stretching and strengthening exercises, educating patient, and intense proprioception and positional exercises.
Detailed Description
To determine the evidences for the efficacy of SNAGs in the Management of Mechanical Neck Pain.
100 patients [Age group 25-45 yrs] who were diagnosed with neck pain, with onset ˃1-3 months (chronic) were randomly assigned to group A receiving conventional Physiotherapy plus SNAGs and group B receiving conventional Physiotherapy plus ultrasound.
Subjects in-group A that received conventional Physiotherapy plus SNAGs showed greater Improvement in pain and range of motion compared with the conventional Physiotherapy plus ultrasound group on 2nd week compared with pretreatment.
The result of study suggests that both SNAGs and Ultrasound groups improves the symptoms of neck pain. Ultrasound group improved the pain symptoms but was too small to reach satisfactory outcome for patients. Based on these results conventional Physiotherapy plus SNAGs should be the treatment of choice for neck pain rather than conventional Physiotherapy plus Ultrasound .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants randomly assigned to group A receiving conventional Physiotherapy plus SNAGs and group B receiving conventional Physiotherapy plus ultrasound.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mean and standard deviations of age and height between group A and B
Arm Type
Experimental
Arm Description
100 subjects with a mean age of 30.82±6.75 (group A, 31.42±6.67; group B, 30.82±6.82) ranging from 20 to 45 years, with a mean height of 165.52±7.85 (group A, 164.92±7.79; group B, 166.12±7.87) centimeters
Arm Title
Between group comparison of VAS, NDI and ROM
Arm Type
Experimental
Arm Description
VAS, NDI and Neck ROM between two groups were compared at pretest (0 day) and posttest (end of two weeks)
Intervention Type
Other
Intervention Name(s)
Ultrasound Therapy, SNAGs
Other Intervention Name(s)
Hot Pack, Exercise
Primary Outcome Measure Information:
Title
Visual analog scale
Description
Visual analog scale is a subjective outcome measurement where patients judge the intensity of their pain on a scale of 0-10, which is in the form of a 10cm straight line. On this 0-10 scale, zero denotes no pain and ten denotes severe pain intensity.
Time Frame
2 weeks
Title
Neck Range of motion
Description
Range of motion of the cervical spine measured by bubble inclinometer. It consists of a 360-degree scale with a fluid filled circular tube containing a small air bubble. It is a gravity dependent Goniometer, which uses the gravity's effect on fluid level to measure joint position and motion.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Neck disability Index
Description
Neck disability Index contains 10 items, seven related to activities of daily living, two related to pain, and one item related to concentration. Each item is scored ranging from 0 (no pain or disability) to 5 (severe pain and disability); and the total score is expressed as a percentage, with higher scores corresponding to greater disability.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria
Age group between 20- 45 years.
Both Gender male and female.
Individuals having localized pain or stiffness in spine or both combined b/w C3 to C7 without upper limbs radiculopathy.
Pain reported on VAS score ˃3 in neck region.
Patients agree to sign written consent form.
Exclusion Criteria Patients were excluded if they were diagnosed with following conditions for ˃6 months:
T.B, carcinoma, heart disease, osteoporosis.
Neural disorders due to PIVD.
Any trauma or localized infection in neck region.
Upper MND, cervical stenosis, metabolic diseases in bone and joint.
Hyper flexibility
Open sores,
Ongoing radiotherapy, chemotherapy, steroid therapy or anticoagulants.
Psychiatric diseases such as phobia/obsession, depression.
Allergy to hot pack
Patients with history of surgery in cervical spine region with in a year.
12. IPD Sharing Statement
Plan to Share IPD
No
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SNAGs in Mechanical Neck Pain
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