Cervicobrachial NeuralgiaNCT02595294
Hypoalgesic Effect of Neural Mobilization
A study testing Cervical Lateral Glide neural mobilization in people with Cervicobrachial Neuralgia, run by Universidad Europea de Madrid at 1 site in Venezuela.
Trial summary
The purpose of these study is to compare the effectivity of the Cervical Lateral Glide physical therapy neural mobilization technique to the complete absence of treatment in a group of patients who suffer cervicobrachial pain. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cervicobrachial Neuralgia
- What is being tested?
- Cervical Lateral Glide neural mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteVenezuela
- Study dates
- Jul 2015to Oct 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of cervicobrachial pain confirmed by magnetic resonance imaging
- Presence of unilateral symptoms of arm pain, paresthesia or numbness in the upper extremity during at least 3 continuous months previous to the application of treatment.
- Positive results in all of the following tests: Spurling, Distraction, and Upper Limb
Who cannot join
- Contraindication in the use of nonsteroidal anti inflammatory drugs (NSAIDs)
- The use of any type of treatment, therapy, procedure or drug to relieve pain
- Patients who are under anticonvulsant, antidepressant or psychotropic medication
- Vertebral instability
- Vertebral osteoporosis
- Vertebral or spine infection.
Show all 13Show fewer
- Neurologic diseases of genetic, infectious or neoplastic origin
- Cervical stenosis myelopathy
- Pregnancy
- Kinesiophobia
- Endocrine disorders and menopause
- History of spine surgery
- Intellectual disability, severe mental illness, intoxication, severe sleep deprivation, Alzheimer's disease.
Trial locations and contacts
1 site in 1 country.
Venezuela1 site
"Centro Médico y de Especialidades Pediátricas Dr. José Gregorio Hernández "
San Diego, Carabobo, 02006
About this study
Official title: Hypoalgesic Effect of Neural Mobilization in Cervicobrachial Pain Compared to a Controlled Group
The purpose of these study is to compare the effectivity of the Cervical Lateral Glide physical therapy neural mobilization technique to the complete absence of treatment in a group of patients who suffer cervicobrachial pain.
Read the detailed description
The Cervical Lateral Glide (CLG) is a neural tissue mobilization technique capable of achieving a hypoalgesic effect during the onset of cervicobrachial pain symptoms. This happens through a series of complex physiologic interactions which are not fully understood. The CLG Physical therapy technique consists of controlled movements of the cervical and brachial plexus neural tissue. Hypoalgesic effect produced by CLG is associated to an increase in neural tissue mobility, edema, inflammation and intraneural pressure reduction, without any known side effects when applied properly, except for a momentary worsening of symptoms (the only known side effect of CLG), which is an important contrast to the wide and sometimes severe spectrum of side effects derived from drug therapy used to treat cervicobrachial pain.
It is believed that the hypoalgesic effect offered by neural tissue mobilization is a consequence of descending nervous system pain modulation activity and an improvement in the distinct biomechanical properties of the involved neural tissue.Despite the increase in scientific interest in evidence based options to treat pain and neural tissue mobilization techniques there is a current lack of enough controlled double blind clinical trials that measure the effectiveness of neural tissue mobilization techniques such as the CLG and its specific effect over cervicobrachial pain. For this reason the present investigation consisted in the application of a treatment protocol based on CLG neural tissue mobilization in a controlled double blind clinical trial with the aim to assess its clinical effectiveness in treating pain symptoms
- Conditions
- Cervicobrachial Neuralgia
- Being tested
- Cervical Lateral Glide neural mobilization
- Medical subject headings
- Brachial Plexus Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Lateral Glide neural mobilizationProcedure or surgery
Also called Cervical Lateral Glide Neural Tissue Mobilization, Cervical Lateral Glide Neurodynamics
Non-surgical non-invasive Cervical Lateral Glide neural mobilization procedure was applied by a physical therapist continuously during 2 minutes in 5 different occasions with 1 minute of rest between each 2 minute application of the Neural Mobilization technique. The intervention was applied during a period of 6 weeks. The correct linear alignment of patient's cervical spine was determined through the baseline use of a Universal Goniometer Device in each application of Cervical Lateral Glide neural mobilization.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Lateral Glide | Experimental | * 15 minutes Cervical Lateral Glide neural mobilization
* 5 times a week
* During 6 weeks
* Patient's adequate cervical spine linear alignment was determined through the baseline use of a Universal Goniometer Device in each application of Cervical Lateral Glide neural mobilization. Receives: Procedure: Cervical Lateral Glide neural mobilization |
| Waiting list control group | No intervention | - Patients assigned to a 6 week waiting list to receive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline using the Numeric Rating Scale for Pain at 1 hour
the Numeric Rating scale for Pain (NRS) is an 11 point scale for patient self reporting of pain in which 0 points represents the total absence of pain and 10 points the worst state of pain, it was employed to evaluate the presence and relieve of cervicobrachial pain symptoms.
Measured: at baseline for both arms and 1 hour after the application of treatment only in the experimental arm, corresponding to intervention days 1, 15 and 30
Secondary outcomes (2)
Change from baseline of the Physical function involving the affected upper limb using the Quik DASH Scale
The disabilities of the arm quick test (Quick DASH) is a self report short questionnaire designed to measure physical function and symptoms in people with any or several musculoskeletal disorders of the upper limb.
Measured: at baseline, corresponding to intervention days 1 and 30 of treatment
Cervical Rotation Range of Motion (CROM)
Cervical rotation was assessed in units of rotation degrees, using the cervical range-of-motion device (CROM).
Measured: at baseline for both arms and 1 hour after the application of treatment only in the experimental arm, corresponding to intervention days 1 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (109)Papers the sponsor has linked to this study.
- Other trials for Cervicobrachial NeuralgiaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Unda Solano, Universidad Europea de Madrid
- Investigators
- Francisco H Unda, PT, MSc, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595294
- Sponsor's protocol ID
- CE0072015-2
- Other IDs
- CE0072015
- Status last verified
- Oct 2019
- First submitted
- 26 Oct 2015
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schug SA, Goddard C. Recent advances in the pharmacological management of acute and chronic pain. Ann Palliat Med. 2014 Oct;3(4):263-75. doi: 10.3978/j.issn.2224-5820.2014.10.02.
PubMed 25841906Cowell IM, Phillips DR. Effectiveness of manipulative physiotherapy for the treatment of a neurogenic cervicobrachial pain syndrome: a single case study -- experimental design. Man Ther. 2002 Feb;7(1):31-8. doi: 10.1054/math.2001.0429.
PubMed 11884154Salt E, Wright C, Kelly S, Dean A. A systematic literature review on the effectiveness of non-invasive therapy for cervicobrachial pain. Man Ther. 2011 Feb;16(1):53-65. doi: 10.1016/j.math.2010.09.005. Epub 2010 Nov 12.
PubMed 21075037Allison GT, Nagy BM, Hall T. A randomized clinical trial of manual therapy for cervico-brachial pain syndrome -- a pilot study. Man Ther. 2002 May;7(2):95-102. doi: 10.1054/math.2002.0453.
PubMed 12151246Huisstede BM, Bierma-Zeinstra SM, Koes BW, Verhaar JA. Incidence and prevalence of upper-extremity musculoskeletal disorders. A systematic appraisal of the literature. BMC Musculoskelet Disord. 2006 Jan 31;7:7. doi: 10.1186/1471-2474-7-7.
PubMed 16448572Radhakrishnan K, Litchy WJ, O'Fallon WM, Kurland LT. Epidemiology of cervical radiculopathy. A population-based study from Rochester, Minnesota, 1976 through 1990. Brain. 1994 Apr;117 ( Pt 2):325-35. doi: 10.1093/brain/117.2.325.
PubMed 8186959Daffner SD, Hilibrand AS, Hanscom BS, Brislin BT, Vaccaro AR, Albert TJ. Impact of neck and arm pain on overall health status. Spine (Phila Pa 1976). 2003 Sep 1;28(17):2030-5. doi: 10.1097/01.BRS.0000083325.27357.39.
PubMed 12973155Isabel de-la-Llave-Rincon A, Puentedura EJ, Fernandez-de-Las-Penas C. Clinical presentation and manual therapy for upper quadrant musculoskeletal conditions. J Man Manip Ther. 2011 Nov;19(4):201-11. doi: 10.1179/106698111X13129729551985.
PubMed 23115473Antonelli BA, de Paula Xavier AA, Oenning P, Baumer MH, da Silva TF, Pilatti LA. Prevalence of cervicobrachial discomforts in elementary school teachers. Work. 2012;41 Suppl 1:5709-14. doi: 10.3233/WOR-2012-0927-5709.
PubMed 22317661Dillingham TR. Evaluating the patient with suspected radiculopathy. PM R. 2013 May;5(5 Suppl):S41-9. doi: 10.1016/j.pmrj.2013.03.015. Epub 2013 Mar 19.
PubMed 23524070Boyles R, Toy P, Mellon J Jr, Hayes M, Hammer B. Effectiveness of manual physical therapy in the treatment of cervical radiculopathy: a systematic review. J Man Manip Ther. 2011 Aug;19(3):135-42. doi: 10.1179/2042618611Y.0000000011.
PubMed 22851876Eubanks JD. Cervical radiculopathy: nonoperative management of neck pain and radicular symptoms. Am Fam Physician. 2010 Jan 1;81(1):33-40.
PubMed 20052961Peolsson A, Soderlund A, Engquist M, Lind B, Lofgren H, Vavruch L, Holtz A, Winstrom-Christersson A, Isaksson I, Oberg B. Physical function outcome in cervical radiculopathy patients after physiotherapy alone compared with anterior surgery followed by physiotherapy: a prospective randomized study with a 2-year follow-up. Spine (Phila Pa 1976). 2013 Feb 15;38(4):300-7. doi: 10.1097/BRS.0b013e31826d2cbb.
PubMed 23407407Caridi 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 23024624Young IA, Michener LA, Cleland JA, Aguilera AJ, Snyder AR. Manual therapy, exercise, and traction for patients with cervical radiculopathy: a randomized clinical trial. Phys Ther. 2009 Jul;89(7):632-42. doi: 10.2522/ptj.20080283. Epub 2009 May 21.
PubMed 19465371
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoalgesic Effect of Neural Mobilization in Cervicobrachial Pain Compared to a Controlled Group
- ClinicalTrials.gov ID
- NCT02595294
- Acronym / sponsor ID
- CE0072015-2
- Conditions
- Cervicobrachial Neuralgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Nov 2015 (estimated)
- 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.
The purpose of these study is to compare the effectivity of the Cervical Lateral Glide physical therapy neural mobilization technique to the complete absence of treatment in a group of patients who suffer cervicobrachial pain.
Detailed description
The Cervical Lateral Glide (CLG) is a neural tissue mobilization technique capable of achieving a hypoalgesic effect during the onset of cervicobrachial pain symptoms. This happens through a series of complex physiologic interactions which are not fully understood. The CLG Physical therapy technique consists of controlled movements of the cervical and brachial plexus neural tissue. Hypoalgesic effect produced by CLG is associated to an increase in neural tissue mobility, edema, inflammation and intraneural pressure reduction, without any known side effects when applied properly, except for a momentary worsening of symptoms (the only known side effect of CLG), which is an important contrast to the wide and sometimes severe spectrum of side effects derived from drug therapy used to treat cervicobrachial pain.
It is believed that the hypoalgesic effect offered by neural tissue mobilization is a consequence of descending nervous system pain modulation activity and an improvement in the distinct biomechanical properties of the involved neural tissue.Despite the increase in scientific interest in evidence based options to treat pain and neural tissue mobilization techniques there is a current lack of enough controlled double blind clinical trials that measure the effectiveness of neural tissue mobilization techniques such as the CLG and its specific effect over cervicobrachial pain. For this reason the present investigation consisted in the application of a treatment protocol based on CLG neural tissue mobilization in a controlled double blind clinical trial with the aim to assess its clinical effectiveness in treating pain symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Lateral Glide | Experimental | Procedure: Cervical Lateral Glide neural mobilization* 15 minutes Cervical Lateral Glide neural mobilization * 5 times a week * During 6 weeks * Patient's adequate cervical spine linear alignment was determined through the baseline use of a Universal Goniometer Device in each application of Cervical Lateral Glide neural mobilization. |
| Waiting list control group | No intervention | –- Patients assigned to a 6 week waiting list to receive treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of cervicobrachial pain confirmed by magnetic resonance imaging
- Presence of unilateral symptoms of arm pain, paresthesia or numbness in the upper extremity during at least 3 continuous months previous to the application of treatment.
- Positive results in all of the following tests: Spurling, Distraction, and Upper Limb
Key exclusion criteria (13 listed)
- Contraindication in the use of nonsteroidal anti inflammatory drugs (NSAIDs)
- The use of any type of treatment, therapy, procedure or drug to relieve pain
- Patients who are under anticonvulsant, antidepressant or psychotropic medication
- Vertebral instability
- Vertebral osteoporosis
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 |
|---|---|---|
| Cervical Lateral Glide neural mobilizationAlso: Cervical Lateral Glide Neural Tissue Mobilization, Cervical Lateral Glide NeurodynamicsNon-surgical non-invasive Cervical Lateral Glide neural mobilization procedure was applied by a physical therapist continuously during 2 minutes in 5 different occasions with 1 minute of rest between each 2 minute application of the Neural Mobilization technique. The intervention was applied during a period of 6 weeks. The correct linear alignment of patient's cervical spine was determined through the baseline use of a Universal Goniometer Device in each application of Cervical Lateral Glide neural mobilization. | Procedure or surgery | Cervical Lateral Glide |
Primary outcome
Change from baseline using the Numeric Rating Scale for Pain at 1 hour
Time frame: at baseline for both arms and 1 hour after the application of treatment only in the experimental arm, corresponding to intervention days 1, 15 and 30
the Numeric Rating scale for Pain (NRS) is an 11 point scale for patient self reporting of pain in which 0 points represents the total absence of pain and 10 points the worst state of pain, it was employed to evaluate the presence and relieve of cervicobrachial pain symptoms.
2 secondary outcomes
Change from baseline of the Physical function involving the affected upper limb using the Quik DASH Scale
Time frame: at baseline, corresponding to intervention days 1 and 30 of treatment
Cervical Rotation Range of Motion (CROM)
Time frame: at baseline for both arms and 1 hour after the application of treatment only in the experimental arm, corresponding to intervention days 1 and 30
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 4 Oct 2019.
- Background: PubMed 25841906Schug SA, Goddard C. Recent advances in the pharmacological management of acute and chronic pain. Ann Palliat Med. 2014 Oct;3(4):263-75. doi: 10.3978/j.issn.2224-5820.2014.10.02.
- Results publication: PubMed 11884154Cowell IM, Phillips DR. Effectiveness of manipulative physiotherapy for the treatment of a neurogenic cervicobrachial pain syndrome: a single case study -- experimental design. Man Ther. 2002 Feb;7(1):31-8. doi: 10.1054/math.2001.0429.
- Results publication: PubMed 21075037Salt E, Wright C, Kelly S, Dean A. A systematic literature review on the effectiveness of non-invasive therapy for cervicobrachial pain. Man Ther. 2011 Feb;16(1):53-65. doi: 10.1016/j.math.2010.09.005. Epub 2010 Nov 12.
- Results publication: PubMed 12151246Allison GT, Nagy BM, Hall T. A randomized clinical trial of manual therapy for cervico-brachial pain syndrome -- a pilot study. Man Ther. 2002 May;7(2):95-102. doi: 10.1054/math.2002.0453.
- Results publication: PubMed 16448572Huisstede BM, Bierma-Zeinstra SM, Koes BW, Verhaar JA. Incidence and prevalence of upper-extremity musculoskeletal disorders. A systematic appraisal of the literature. BMC Musculoskelet Disord. 2006 Jan 31;7:7. doi: 10.1186/1471-2474-7-7.
- Results publication: PubMed 8186959Radhakrishnan K, Litchy WJ, O'Fallon WM, Kurland LT. Epidemiology of cervical radiculopathy. A population-based study from Rochester, Minnesota, 1976 through 1990. Brain. 1994 Apr;117 ( Pt 2):325-35. doi: 10.1093/brain/117.2.325.
- Results publication: PubMed 12973155Daffner SD, Hilibrand AS, Hanscom BS, Brislin BT, Vaccaro AR, Albert TJ. Impact of neck and arm pain on overall health status. Spine (Phila Pa 1976). 2003 Sep 1;28(17):2030-5. doi: 10.1097/01.BRS.0000083325.27357.39.
- Results publication: PubMed 23115473Isabel de-la-Llave-Rincon A, Puentedura EJ, Fernandez-de-Las-Penas C. Clinical presentation and manual therapy for upper quadrant musculoskeletal conditions. J Man Manip Ther. 2011 Nov;19(4):201-11. doi: 10.1179/106698111X13129729551985.
- Results publication: PubMed 22317661Antonelli BA, de Paula Xavier AA, Oenning P, Baumer MH, da Silva TF, Pilatti LA. Prevalence of cervicobrachial discomforts in elementary school teachers. Work. 2012;41 Suppl 1:5709-14. doi: 10.3233/WOR-2012-0927-5709.
- Results publication: PubMed 23524070Dillingham TR. Evaluating the patient with suspected radiculopathy. PM R. 2013 May;5(5 Suppl):S41-9. doi: 10.1016/j.pmrj.2013.03.015. Epub 2013 Mar 19.
- Results publication: PubMed 22851876Boyles R, Toy P, Mellon J Jr, Hayes M, Hammer B. Effectiveness of manual physical therapy in the treatment of cervical radiculopathy: a systematic review. J Man Manip Ther. 2011 Aug;19(3):135-42. doi: 10.1179/2042618611Y.0000000011.
- Results publication: PubMed 20052961Eubanks JD. Cervical radiculopathy: nonoperative management of neck pain and radicular symptoms. Am Fam Physician. 2010 Jan 1;81(1):33-40.
- DASH Outcome Measure Institute for Work \& HealthLink provided by the sponsor.
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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.
Francisco H Unda, PT, MSc principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Lateral Glide neural mobilization in people with Cervicobrachial Neuralgia, run by Universidad Europea de Madrid at 1 site in Venezuela.
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 13 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 4 Oct 2019. 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 Venezuela. 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?
Change from baseline using the Numeric Rating Scale for Pain at 1 hour (time frame: at baseline for both arms and 1 hour after the application of treatment only in the experimental arm, corresponding to intervention days 1, 15 and 30). 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 NCT02595294, which also lists 109 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 4 Oct 2019; AzTrials last refreshed its copy on 31 Oct 2026.