Cervical RadiculopathyNCT05021510
Simultaneous Traction and Neural Mobilization
A study testing Simultaneous Cervical Traction & Neural Mobilization and consecutive Cervical Traction & Neural Mobilization in people with Cervical Radiculopathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Neck pain is a frequently reported complaint of the musculoskeletal system which generally has a huge impact on health care expenditure; ascribed to visits to health care providers, disability, and sick leaves. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Simultaneous Cervical Traction & Neural Mobilization and consecutive Cervical Traction & Neural Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2021to 20 Aug 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants with Chronic Cervical Radiculopathy for 6 months will be included.
- Participants with Positive Spurling and Upper Limb Neural Tension Tests (ULNTTs) will be included.
- Participants of age 20 to 60 will be included
Who cannot join
- The participants with cervical myelopathy and other pathologies will not be included.
- The participants with Vertigo/dizziness will not be included.
- The participants with bilateral symptoms will not be included.
- The participants with other musculoskeletal conditions in the affected limb will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Simultaneous Traction and Neural Mobilization on Pain and Function in Cervical Radiculopathy.
Neck pain is a frequently reported complaint of the musculoskeletal system which generally has a huge impact on health care expenditure; ascribed to visits to health care providers, disability, and sick leaves. A variety of manual therapy techniques including Cervical traction (CT) and neural mobilization techniques (NMTs) have been prescribed in the management of CR because of their immediate analgesic effect. Both techniques have been proposed to reduce pain and functional limitations in CR. Traction increases the separation of the vertebral bodies which eventually reduces the central pressure in the disk space and encourages the disk nucleus to get back to a central position. The current literature lends assistance to the utilization of the traction in addition to other physical therapy procedures for pain reduction, with less significant impact on function and disability. Further studies should investigate to explore the most effective traction method and dosage, the subgroups of patients with CR, or the pain stage (acute, subacute, or chronic) most benefited by this intervention and the physical therapy procedures that yield the most effective outcomes when combined with traction.
Read the detailed description
Researchers have started exploring that neural tissue mobilization along with conventional treatment is more effective in decreasing pain and improving cervical range of motion and mental component of quality of life in unilateral cervical radiculopathy (CR) patients than intermittent cervical traction and conventional treatment. Future randomized controlled trials are warranted with the purpose to compare the long-term effectiveness of cervical traction with neural mobilization in CR, as well as the effect of these two techniques in comparison with other interventions. Some literature recommended the simultaneous application of mechanical cervical traction along with neural mobilization in the treatment of Unilateral Cervical Radiculopathy. There are numerous studies in which both groups received Cervical traction (CT) and neural mobilization (NM) was added in only one group along with cervical traction or studies in which both groups received NM and CT was administered in only one group as well, there are also some studies in which one group received only CT and other group received only NM but there isn't any study yet in which we can compare the effect of simultaneous administration of CT and NM and consecutive administration of CT and NM.
Pain and functional limitation in cervical radiculopathy can be treated with mechanical cervical traction and neural mobilization. The purpose of the study is to determine that is simultaneous administration of cervical traction and neural mobilization is more effective than consecutive administration in the management of cervical radiculopathy. The findings of the study will provide an insight into the low-cost evidence-based conservative management of cervical radiculopathy.
- Conditions
- Cervical Radiculopathy
- Being tested
- Simultaneous Cervical Traction & Neural Mobilization, consecutive Cervical Traction & Neural Mobilization
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous Cervical Traction & Neural MobilizationOther
Simultaneously Mechanical Cervical traction with Neural Mobilization of the upper limb for 3 times a week, 45 minutes per day for 4 weeks
consecutive Cervical Traction & Neural MobilizationOther
consecutive Mechanical Cervical traction with Neural Mobilization of the upper limb for 3 times a week, 45 minutes per day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous Cervical Traction & Neural Mobilization | Experimental | Traction is a maneuver of distracting force to the cervical spine to cervical segments/grants decompression of nerve roots. For traction, 10% of the total body weight would be taken. Previous researches that investigated cervical traction found adequate effectiveness on pain reduction in neck and arm as well as improvement in nerve function parameters, and enhancement in neck mobility. The patient would be placed in a supine lying position with the cervical spine placed at 15º of flexion. The head strap will be fitted under the patient's occiput and chin. A safety switch will be given to the patient and ask him to press it if he would feel any kind of discomfort. Receives: Other: Simultaneous Cervical Traction & Neural Mobilization |
| consecutive Cervical Traction & Neural Mobilization | Active comparator | the same description is for active comparator except for treatment mode to consecutive. Receives: Other: consecutive Cervical Traction & Neural Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
NPRS for pain is a unidimensional measure of pain intensity. Similar to visual analogue scale (VAS), the NPRS is anchored by describing pain severity extremes. The NPRS can be administered verbally or graphically for self-completion.
Measured: week 4
Neck Disability Index (NDI) for function
NDI used to measure cervical pain and functional disability. The NDI was created using a questionnaire with 10 questions based on the Oswestry Index, which evaluates restrictions to ordinary life in relation to lumbar pain. The subjects selected a score of one to six (0 to 5) in 10 items: reading, headache, concentration, work, driving, sleeping, leisure life, pain intensity, ordinary life, and raising an object.
The higher the sum of each item's score, the more severe the functional disability related to cervical abnormality. Zero to four points, five to 14 points, 15 to 24 points, 25 to 34 points, and 35 points or higher signify no disability, weak disability, moderate disability, severe disability, and complete disability, respectively
Measured: week 4
Short Form Quality of Life 12: (physical, mental)
The developers of short form (SF) 36 have consequently, suggested that a 12 item sub-set of the items may accurately reproduce the two summary component scores which can be derived from the SF 36 [the physical component score (PCS) and the mental component score (MCS)].
The scores were put in the free online orthopedic calculator "ortho tool kit" and two summary scores have been generated: Physical component score and mental component score.
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start15 Aug 2021
- Primary completion20 Aug 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arshad Malik, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021510
- Sponsor's protocol ID
- REC/01030 Sabah
- Status last verified
- Feb 2023
- First submitted
- 23 Aug 2021
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.
PubMed 25659245Ayub A, Osama M, Ahmad S. Effects of active versus passive upper extremity neural mobilization combined with mechanical traction and joint mobilization in females with cervical radiculopathy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(5):725-730. doi: 10.3233/BMR-170887.
PubMed 30664500Savva C, Korakakis V, Efstathiou M, Karagiannis C. Cervical traction combined with neural mobilization for patients with cervical radiculopathy: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:279-289. doi: 10.1016/j.jbmt.2020.08.019. Epub 2020 Sep 2.
PubMed 33992259Tarazona D, Boody B, Hilibrand AS, Stull J, Bell K, Fang T, Goyal D, Galetta M, Kaye D, Kepler CK, Kurd MF, Woods BI, Radcliff KE, Rihn JA, Anderson DG, Vaccaro AR, Schroeder GD. Longer Preoperative Duration of Symptoms Negatively Affects Health-related Quality of Life After Surgery for Cervical Radiculopathy. Spine (Phila Pa 1976). 2019 May 15;44(10):685-690. doi: 10.1097/BRS.0000000000002924.
PubMed 30395087Efstathiou MA, Stefanakis M, Savva C, Giakas G. Effectiveness of neural mobilization in patients with spinal radiculopathy: a critical review. J Bodyw Mov Ther. 2015 Apr;19(2):205-12. doi: 10.1016/j.jbmt.2014.08.006. Epub 2014 Aug 17.
PubMed 25892373Romeo A, Vanti C, Boldrini V, Ruggeri M, Guccione AA, Pillastrini P, Bertozzi L. Cervical Radiculopathy: Effectiveness of Adding Traction to Physical Therapy-A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Apr 1;98(4):231-242. doi: 10.1093/physth/pzy001.
PubMed 29315428Caridi JM, Pumberger M, Hughes AP. Cervical radiculopathy: a review. HSS J. 2011 Oct;7(3):265-72. doi: 10.1007/s11420-011-9218-z. Epub 2011 Sep 9.
PubMed 23024624
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Simultaneous Traction and Neural Mobilization on Pain and Function in Cervical Radiculopathy.
- ClinicalTrials.gov ID
- NCT05021510
- Acronym / sponsor ID
- REC/01030 Sabah
- Conditions
- Cervical Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 25 Aug 2021 (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 a frequently reported complaint of the musculoskeletal system which generally has a huge impact on health care expenditure; ascribed to visits to health care providers, disability, and sick leaves. A variety of manual therapy techniques including Cervical traction (CT) and neural mobilization techniques (NMTs) have been prescribed in the management of CR because of their immediate analgesic effect. Both techniques have been proposed to reduce pain and functional limitations in CR. Traction increases the separation of the vertebral bodies which eventually reduces the central pressure in the disk space and encourages the disk nucleus to get back to a central position. The current literature lends assistance to the utilization of the traction in addition to other physical therapy procedures for pain reduction, with less significant impact on function and disability. Further studies should investigate to explore the most effective traction method and dosage, the subgroups of patients with CR, or the pain stage (acute, subacute, or chronic) most benefited by this intervention and the physical therapy procedures that yield the most effective outcomes when combined with traction.
Detailed description
Researchers have started exploring that neural tissue mobilization along with conventional treatment is more effective in decreasing pain and improving cervical range of motion and mental component of quality of life in unilateral cervical radiculopathy (CR) patients than intermittent cervical traction and conventional treatment. Future randomized controlled trials are warranted with the purpose to compare the long-term effectiveness of cervical traction with neural mobilization in CR, as well as the effect of these two techniques in comparison with other interventions. Some literature recommended the simultaneous application of mechanical cervical traction along with neural mobilization in the treatment of Unilateral Cervical Radiculopathy. There are numerous studies in which both groups received Cervical traction (CT) and neural mobilization (NM) was added in only one group along with cervical traction or studies in which both groups received NM and CT was administered in only one group as well, there are also some studies in which one group received only CT and other group received only NM but there isn't any study yet in which we can compare the effect of simultaneous administration of CT and NM and consecutive administration of CT and NM.
Pain and functional limitation in cervical radiculopathy can be treated with mechanical cervical traction and neural mobilization. The purpose of the study is to determine that is simultaneous administration of cervical traction and neural mobilization is more effective than consecutive administration in the management of cervical radiculopathy. The findings of the study will provide an insight into the low-cost evidence-based conservative management of cervical radiculopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simultaneous Cervical Traction & Neural Mobilization | Experimental | Other: Simultaneous Cervical Traction & Neural MobilizationTraction is a maneuver of distracting force to the cervical spine to cervical segments/grants decompression of nerve roots. For traction, 10% of the total body weight would be taken. Previous researches that investigated cervical traction found adequate effectiveness on pain reduction in neck and arm as well as improvement in nerve function parameters, and enhancement in neck mobility. The patient would be placed in a supine lying position with the cervical spine placed at 15º of flexion. The head strap will be fitted under the patient's occiput and chin. A safety switch will be given to the patient and ask him to press it if he would feel any kind of discomfort. |
| consecutive Cervical Traction & Neural Mobilization | Active comparator | Other: consecutive Cervical Traction & Neural Mobilizationthe same description is for active comparator except for treatment mode to consecutive. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants with Chronic Cervical Radiculopathy for 6 months will be included.
- Participants with Positive Spurling and Upper Limb Neural Tension Tests (ULNTTs) will be included.
- Participants of age 20 to 60 will be included
Key exclusion criteria (4 listed)
- The participants with cervical myelopathy and other pathologies will not be included.
- The participants with Vertigo/dizziness will not be included.
- The participants with bilateral symptoms will not be included.
- The participants with other musculoskeletal conditions in the affected limb will not be included.
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 |
|---|---|---|
| Simultaneous Cervical Traction & Neural MobilizationSimultaneously Mechanical Cervical traction with Neural Mobilization of the upper limb for 3 times a week, 45 minutes per day for 4 weeks | Other | Simultaneous Cervical Traction & Neural Mobilization |
| consecutive Cervical Traction & Neural Mobilizationconsecutive Mechanical Cervical traction with Neural Mobilization of the upper limb for 3 times a week, 45 minutes per day for 4 weeks | Other | consecutive Cervical Traction & Neural Mobilization |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: week 4
NPRS for pain is a unidimensional measure of pain intensity. Similar to visual analogue scale (VAS), the NPRS is anchored by describing pain severity extremes. The NPRS can be administered verbally or graphically for self-completion.
Neck Disability Index (NDI) for function
Time frame: week 4
NDI used to measure cervical pain and functional disability. The NDI was created using a questionnaire with 10 questions based on the Oswestry Index, which evaluates restrictions to ordinary life in relation to lumbar pain. The subjects selected a score of one to six (0 to 5) in 10 items: reading, headache, concentration, work, driving, sleeping, leisure life, pain intensity, ordinary life, and raising an object. The higher the sum of each item's score, the more severe the functional disability related to cervical abnormality. Zero to four points, five to 14 points, 15 to 24 points, 25 to 34 points, and 35 points or higher signify no disability, weak disability, moderate disability, severe disability, and complete disability, respectively
Short Form Quality of Life 12: (physical, mental)
Time frame: week 4
The developers of short form (SF) 36 have consequently, suggested that a 12 item sub-set of the items may accurately reproduce the two summary component scores which can be derived from the SF 36 [the physical component score (PCS) and the mental component score (MCS)]. The scores were put in the free online orthopedic calculator "ortho tool kit" and two summary scores have been generated: Physical component score and mental component score.
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 24 Feb 2023.
- Background: PubMed 25659245Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.
- Background: PubMed 30664500Ayub A, Osama M, Ahmad S. Effects of active versus passive upper extremity neural mobilization combined with mechanical traction and joint mobilization in females with cervical radiculopathy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(5):725-730. doi: 10.3233/BMR-170887.
- Background: PubMed 33992259Savva C, Korakakis V, Efstathiou M, Karagiannis C. Cervical traction combined with neural mobilization for patients with cervical radiculopathy: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:279-289. doi: 10.1016/j.jbmt.2020.08.019. Epub 2020 Sep 2.
- Background: PubMed 30395087Tarazona D, Boody B, Hilibrand AS, Stull J, Bell K, Fang T, Goyal D, Galetta M, Kaye D, Kepler CK, Kurd MF, Woods BI, Radcliff KE, Rihn JA, Anderson DG, Vaccaro AR, Schroeder GD. Longer Preoperative Duration of Symptoms Negatively Affects Health-related Quality of Life After Surgery for Cervical Radiculopathy. Spine (Phila Pa 1976). 2019 May 15;44(10):685-690. doi: 10.1097/BRS.0000000000002924.
- Background: PubMed 25892373Efstathiou MA, Stefanakis M, Savva C, Giakas G. Effectiveness of neural mobilization in patients with spinal radiculopathy: a critical review. J Bodyw Mov Ther. 2015 Apr;19(2):205-12. doi: 10.1016/j.jbmt.2014.08.006. Epub 2014 Aug 17.
- Background: PubMed 29315428Romeo A, Vanti C, Boldrini V, Ruggeri M, Guccione AA, Pillastrini P, Bertozzi L. Cervical Radiculopathy: Effectiveness of Adding Traction to Physical Therapy-A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Apr 1;98(4):231-242. doi: 10.1093/physth/pzy001.
- Background: PubMed 23024624Caridi JM, Pumberger M, Hughes AP. Cervical radiculopathy: a review. HSS J. 2011 Oct;7(3):265-72. doi: 10.1007/s11420-011-9218-z. Epub 2011 Sep 9.
- 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.
Arshad Malik, PhD 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 Simultaneous Cervical Traction & Neural Mobilization and consecutive Cervical Traction & Neural Mobilization in people with Cervical Radiculopathy, 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 3 inclusion and 4 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 24 Feb 2023. 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: week 4). 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 NCT05021510, which also lists 7 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 24 Feb 2023.