Radiculopathy, CervicalNCT05191537
Spinal Mobilization With Arm Movement and Positional SNAGS in Cervical Radiculopathy Patients
A study testing Sustained Natural Apophyseal Glides and shoulder Mobilization with arm movement in people with Radiculopathy, Cervical, run by Riphah International University at 1 site in Pakistan.
Trial summary
Data will be collected in Hussain Memorial Hospital by taking informed consent. Randomised clinical trial is conducted taking thirty patients of both genders with confirmed diagnoses of cervical radiculopathy, their ages ranged from 25 to 60. A cluster of winner to rule out patient with cervical radiculopathy. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Radiculopathy, Cervical
- What is being tested?
- Sustained Natural Apophyseal Glides and shoulder Mobilization with arm movement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2021to 10 Apr 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptoms duration more than 6 months.
- Age 25 -60
- The patient has confirm the diagnosis of Radiculopathy of cervical origin,
- VAS more than 5
- A cluster of Wainner 3 positive out of 4 EXCLUSION CRITERIA
- Malignancy
Show all 14Show fewer
- Infection (such as osteomyelitis or diskettes)
- Osteoporosis
- Inflammatory arthritis
- Fracture
- Pregnancy
- Uncontrolled hypertension or cardiovascular disease
- Carotid or vertebral artery disease.
- Trauma cases
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Spinal Mobilization With Arm Movement and Positional SNAGS on Pain and Disability in Cervical Radiculopathy Patients
Data will be collected in Hussain Memorial Hospital by taking informed consent. Randomised clinical trial is conducted taking thirty patients of both genders with confirmed diagnoses of cervical radiculopathy, their ages ranged from 25 to 60. A cluster of winner to rule out patient with cervical radiculopathy. They will be randomly assigned into two groups by the lottery method. Group A will receive conventional treatment and of spinal mobilization with arm movement (intervention 1) Group B will receive conventional treatment and positional SNAGs (intervention 2). The treatment will be conducted at a frequency of three sessions per week for four weeks. Two values will be taken, one as baseline and the other at end of the session.
Then follow up the patient to rule out which intervention is more effective than the other. Neck Disability Index, Numeric Pain Rating Scale and ROM will be used to measure outcomes.
Read the detailed description
the objective of the study is To compare the effect of spinal mobilization with arm movement and positional SNAGs on pain and disability in cervical radiculopathy patients.
The study design will be Randomized ClinicalTrial The sampling Technique will be Consecutive sampling technique
Tool:
The Neck Disability Index (NDI): used for measuring functional improvement in the neck.
Numeric Pain Rating Scale (NPRS): used for measuring pain.
Inclinometer: used for measuring Range of motion of cervical region.
Data will be collected in Hussain Memorial Hospital by taking informed consent. Randomised clinical trial is conducted taking thirty patients of both genders with confirmed diagnoses of cervical radiculopathy, their ages ranged from 25 to 60. A cluster of winner criteria will be used to rule out patient with cervical radiculopathy. They will be randomly assigned into two groups by the lottery method. Group A will receive conventional treatment and of spinal mobilization with arm movement (intervention 1) Group B will receive conventional treatment and positional SNAGs (intervention 2). The treatment will be conducted at a frequency of three sessions per week for four weeks. Two values will be taken, one as baseline and the other at end of the session.
Then follow up the patient to rule out which intervention is more effective than the other. Neck Disability Index, Numeric Pain Rating Scale and ROM will be used to measure outcomes.
- Conditions
- Radiculopathy, Cervical
- Being tested
- Sustained Natural Apophyseal Glides, shoulder Mobilization with arm movement
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained Natural Apophyseal GlidesOther
The patient sits well supported in a chair. The cervical spine and head are set in a neutral position. A painless passive posterior to anterior (PA) glide is applied in the plane of the facets on either the spinous process or the articular pillar/cervical lamina. While the glide is sustained the patient actively moves their neck in the direction that previously produced the symptoms. If symptom-free, the patient applies over-pressure further into the movement restriction. 3-6 repetitions are performed
shoulder Mobilization with arm movementOther
The patient is seated. The therapist contacts the length of the spinous process with the medial aspect of the thumb. A transverse glide is applied by the therapist's index finger against the thumb contacting the spinous process. The direction of the glide is to the contralateral side of the pain. While the mobilisation is sustained the patient moves their arm through a pain-free abduction range. 3-5 sets of 6-10 repetitions may be performed.
| Study group | Role | What they receive |
|---|---|---|
| spinal mobilization with arm movement | Experimental | conventional treatment and of spinal mobilization with arm movement Receives: Other: shoulder Mobilization with arm movement |
| positional SNAGs | Active comparator | conventional treatment and positional SNAGs Receives: Other: Sustained Natural Apophyseal Glides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
The numeric pain rating scale (NPRS) is a measurement scale that is used to measure a characteristic or attitude of pain. it is a 0-10 point scale. 0 mean no pain and 10 mean unbearable pain. Change from Baseline for pain Assessment at 4 weeks.
Measured: 4 weeks.
Neck Disability Index(NDI)
NDI questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. It had 10 sections with total 50 scores. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. 0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation. Change from Baseline for disability Assessment at 4 weeks.
Measured: 4 weeks.
Inclinometer for range of motion
It's a range measuring tool used for the Range of Motion of neck flexion, extension and rotation. If the angle increases its mean improving. Change from Baseline for Range of Motion Assessment at 4 weeks.
Measured: 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Dec 2021
- Primary completion1 Apr 2022
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Radiculopathy, CervicalStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- muhammad sanaullah, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191537
- Sponsor's protocol ID
- REC/Lhr/21/0127 Maryam
- Status last verified
- Nov 2022
- First submitted
- 29 Dec 2021
- Last updated
- 28 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krivickas LS, Wilbourn AJ. Peripheral nerve injuries in athletes: a case series of over 200 injuries. Semin Neurol. 2000;20(2):225-32. doi: 10.1055/s-2000-9832.
PubMed 10946743Hee HT, Castro FP Jr, Majd ME, Holt RT, Myers L. Anterior/posterior lumbar fusion versus transforaminal lumbar interbody fusion: analysis of complications and predictive factors. J Spinal Disord. 2001 Dec;14(6):533-40. doi: 10.1097/00002517-200112000-00013.
PubMed 11723406Anandkumar S. The effect of sustained natural apophyseal glide (SNAG) combined with neurodynamics in the management of a patient with cervical radiculopathy: a case report. Physiother Theory Pract. 2015 Feb;31(2):140-5. doi: 10.3109/09593985.2014.971922. Epub 2014 Oct 20.
PubMed 25329587Shafique S, Ahmad S, Shakil-Ur-Rehman S. Effect of Mulligan spinal mobilization with arm movement along with neurodynamics and manual traction in cervical radiculopathy patients: A randomized controlled trial. J Pak Med Assoc. 2019 Nov;69(11):1601-1604. doi: 10.5455/JPMA.297956..
PubMed 31740863
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spinal Mobilization With Arm Movement and Positional SNAGS on Pain and Disability in Cervical Radiculopathy Patients
- ClinicalTrials.gov ID
- NCT05191537
- Acronym / sponsor ID
- REC/Lhr/21/0127 Maryam
- Conditions
- Radiculopathy, Cervical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 13 Jan 2022 (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.
Data will be collected in Hussain Memorial Hospital by taking informed consent. Randomised clinical trial is conducted taking thirty patients of both genders with confirmed diagnoses of cervical radiculopathy, their ages ranged from 25 to 60. A cluster of winner to rule out patient with cervical radiculopathy. They will be randomly assigned into two groups by the lottery method. Group A will receive conventional treatment and of spinal mobilization with arm movement (intervention 1) Group B will receive conventional treatment and positional SNAGs (intervention 2). The treatment will be conducted at a frequency of three sessions per week for four weeks. Two values will be taken, one as baseline and the other at end of the session.
Then follow up the patient to rule out which intervention is more effective than the other. Neck Disability Index, Numeric Pain Rating Scale and ROM will be used to measure outcomes.
Detailed description
the objective of the study is To compare the effect of spinal mobilization with arm movement and positional SNAGs on pain and disability in cervical radiculopathy patients.
The study design will be Randomized ClinicalTrial The sampling Technique will be Consecutive sampling technique
Tool:
The Neck Disability Index (NDI): used for measuring functional improvement in the neck.
Numeric Pain Rating Scale (NPRS): used for measuring pain.
Inclinometer: used for measuring Range of motion of cervical region.
Data will be collected in Hussain Memorial Hospital by taking informed consent. Randomised clinical trial is conducted taking thirty patients of both genders with confirmed diagnoses of cervical radiculopathy, their ages ranged from 25 to 60. A cluster of winner criteria will be used to rule out patient with cervical radiculopathy. They will be randomly assigned into two groups by the lottery method. Group A will receive conventional treatment and of spinal mobilization with arm movement (intervention 1) Group B will receive conventional treatment and positional SNAGs (intervention 2). The treatment will be conducted at a frequency of three sessions per week for four weeks. Two values will be taken, one as baseline and the other at end of the session.
Then follow up the patient to rule out which intervention is more effective than the other. Neck Disability Index, Numeric Pain Rating Scale and ROM will be used to measure outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal mobilization with arm movement | Experimental | Other: shoulder Mobilization with arm movementconventional treatment and of spinal mobilization with arm movement |
| positional SNAGs | Active comparator | Other: Sustained Natural Apophyseal Glidesconventional treatment and positional SNAGs |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Symptoms duration more than 6 months.
- Age 25 -60
- The patient has confirm the diagnosis of Radiculopathy of cervical origin,
- VAS more than 5
- A cluster of Wainner 3 positive out of 4 EXCLUSION CRITERIA
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 |
|---|---|---|
| Sustained Natural Apophyseal GlidesThe patient sits well supported in a chair. The cervical spine and head are set in a neutral position. A painless passive posterior to anterior (PA) glide is applied in the plane of the facets on either the spinous process or the articular pillar/cervical lamina. While the glide is sustained the patient actively moves their neck in the direction that previously produced the symptoms. If symptom-free, the patient applies over-pressure further into the movement restriction. 3-6 repetitions are performed | Other | positional SNAGs |
| shoulder Mobilization with arm movementThe patient is seated. The therapist contacts the length of the spinous process with the medial aspect of the thumb. A transverse glide is applied by the therapist's index finger against the thumb contacting the spinous process. The direction of the glide is to the contralateral side of the pain. While the mobilisation is sustained the patient moves their arm through a pain-free abduction range. 3-5 sets of 6-10 repetitions may be performed. | Other | spinal mobilization with arm movement |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 4 weeks.
The numeric pain rating scale (NPRS) is a measurement scale that is used to measure a characteristic or attitude of pain. it is a 0-10 point scale. 0 mean no pain and 10 mean unbearable pain. Change from Baseline for pain Assessment at 4 weeks.
Neck Disability Index(NDI)
Time frame: 4 weeks.
NDI questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. It had 10 sections with total 50 scores. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. 0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation. Change from Baseline for disability Assessment at 4 weeks.
Inclinometer for range of motion
Time frame: 4 weeks.
It's a range measuring tool used for the Range of Motion of neck flexion, extension and rotation. If the angle increases its mean improving. Change from Baseline for Range of Motion Assessment at 4 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 28 Nov 2022.
- Background: PubMed 10946743Krivickas LS, Wilbourn AJ. Peripheral nerve injuries in athletes: a case series of over 200 injuries. Semin Neurol. 2000;20(2):225-32. doi: 10.1055/s-2000-9832.
- Background: PubMed 11723406Hee HT, Castro FP Jr, Majd ME, Holt RT, Myers L. Anterior/posterior lumbar fusion versus transforaminal lumbar interbody fusion: analysis of complications and predictive factors. J Spinal Disord. 2001 Dec;14(6):533-40. doi: 10.1097/00002517-200112000-00013.
- Background: PubMed 25329587Anandkumar S. The effect of sustained natural apophyseal glide (SNAG) combined with neurodynamics in the management of a patient with cervical radiculopathy: a case report. Physiother Theory Pract. 2015 Feb;31(2):140-5. doi: 10.3109/09593985.2014.971922. Epub 2014 Oct 20.
- Background: PubMed 31740863Shafique S, Ahmad S, Shakil-Ur-Rehman S. Effect of Mulligan spinal mobilization with arm movement along with neurodynamics and manual traction in cervical radiculopathy patients: A randomized controlled trial. J Pak Med Assoc. 2019 Nov;69(11):1601-1604. doi: 10.5455/JPMA.297956..
- 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.
muhammad sanaullah, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sustained Natural Apophyseal Glides and shoulder Mobilization with arm movement in people with Radiculopathy, Cervical, run by Riphah International University at 1 site in Pakistan.
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 14 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 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Numeric Pain Rating Scale (NPRS) (time frame: 4 weeks.). The study lists 3 primary outcomes in all. 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 NCT05191537, which also lists 4 linked publications.
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 28 Nov 2022.