Neck PainNCT04617288
SNAGs in Mechanical Neck Pain
A study testing Ultrasound Therapy, SNAGs in people with Neck Pain, run by Raj Nursing and Paramedical College.
Trial 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%. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Ultrasound Therapy, SNAGs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2015to 25 Aug 2015
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
None listed.
About this study
Official title: Efficacy of SNAGs in the Management of Mechanical Neck Pain
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.
Read the 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 .
- Conditions
- Neck Pain
- Being tested
- Ultrasound Therapy, SNAGs
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Therapy, SNAGsOther
Also called Hot Pack, Exercise
| Study group | Role | What they receive |
|---|---|---|
| Mean and standard deviations of age and height between group A and B | Experimental | 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 Receives: Other: Ultrasound Therapy, SNAGs |
| Between group comparison of VAS, NDI and ROM | Experimental | VAS, NDI and Neck ROM between two groups were compared at pretest (0 day) and posttest (end of two weeks) Receives: Other: Ultrasound Therapy, SNAGs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
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.
Measured: 2 weeks
Secondary outcomes (1)
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start10 Aug 2015
- Primary completion25 Aug 2015
- Study completion25 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- Participants randomly assigned to group A receiving conventional Physiotherapy plus SNAGs and group B receiving conventional Physiotherapy plus ultrasound.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raj Nursing and Paramedical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharick Shamsi, Raj Nursing and Paramedical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617288
- Sponsor's protocol ID
- RajNursingParamedicalC
- Status last verified
- Nov 2020
- First submitted
- 30 Oct 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of SNAGs in the Management of Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT04617288
- Acronym / sponsor ID
- RajNursingParamedicalC
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Raj Nursing and Paramedical CollegeUniversity, hospital or other
- Study start
- 10 Aug 2015 (actual)
- Primary completion
- 25 Aug 2015 (actual)
- Study completion
- 25 Aug 2015 (actual)
- First posted
- 5 Nov 2020 (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.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants randomly assigned to group A receiving conventional Physiotherapy plus SNAGs and group B receiving conventional Physiotherapy plus ultrasound.
| Arm | Type | Receives |
|---|---|---|
| Mean and standard deviations of age and height between group A and B | Experimental | Other: Ultrasound Therapy, SNAGs100 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 |
| Between group comparison of VAS, NDI and ROM | Experimental | Other: Ultrasound Therapy, SNAGsVAS, NDI and Neck ROM between two groups were compared at pretest (0 day) and posttest (end of two weeks) |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ultrasound Therapy, SNAGsAlso: Hot Pack, Exercise | Other | Between group comparison of VAS, NDI and ROM, Mean and standard deviations of age and height between group A and B |
Primary outcome
Visual analog scale
Time frame: 2 weeks
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
Time frame: 2 weeks
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.
1 secondary outcome
Neck disability Index
Time frame: 2 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 9 Nov 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Therapy, SNAGs in people with Neck Pain, run by Raj Nursing and Paramedical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. 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 9 Nov 2020. 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 analog scale (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2020.