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Trial registered on ANZCTR


Registration number
ACTRN12617000430336
Ethics application status
Approved
Date submitted
3/09/2016
Date registered
24/03/2017
Date last updated
7/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Short-term effectiveness of cervical lateral glides in isolation or as a component of the median nerve glide in patients with non-acute neck pain.
Scientific title
Short-term effectiveness in pain and functionality of cervical lateral glides in isolation or as a component of the median nerve glide in patients with non-acute neck pain.
Secondary ID [1] 289801 0
None
Universal Trial Number (UTN)
U1111-1185-9031
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non-acute neck pain 299739 0
Condition category
Condition code
Musculoskeletal 299675 299675 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 300124 300124 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Cervical lateral glides as part of the median nerve mobilization. Individual face-to-face intervention. A splint to fix wrist and finger motion of the intervention upper limb will be used, along with a fixation at the shoulder to not let the humeral head to ascend. This will let the patient move the elbow as intended. The intervention is described as follows: 4 sets of mobilizations of 60 seconds each in first session. After that, patient will be instructed orally and subtitled youtube video documented (https://www.youtube.com/watch?v=1q4VWi9tWvg ) to perform median nerve mobilization exercises at home (1 minute per set, 3 times a day, consecutive days) every day until next visit. Next visit: in 2 weeks, same protocol of mobilizations and home-exercises. Final evaluation (no intervention) at 4 weeks.
Patients are phone-called once two days after they have started with exercises at home to clarify doubts and another time in the mid-term between sessions to assure their compliance.

- The interventions will be conducted at University of Alcala and Principe de Asturias Hospital (Spain) and will be delivered by an expert clinician with more than 8 years of expertise.
Intervention code [1] 295491 0
Rehabilitation
Intervention code [2] 295492 0
Treatment: Other
Comparator / control treatment
- Cervical lateral glides in isolation. Individual face-to-face intervention. Arms lean on the patient's abdominal region. The intervention is described as follows: 4 sets of mobilizations of 60 seconds each in first session. After that, patient will be instructed orally and subtitled youtube video documented (https://www.youtube.com/watch?v=1q4VWi9tWvg) to perform median nerve mobilization exercises at home, as in the experimental group (1 minute per set, 3 times a day, consecutive days), every day until next visit. Next visit: in 2 weeks, same protocol of mobilizations and home-exercises. Final evaluation (no intervention) at 4 weeks. Patients are phone-called once two days after they have started with exercises at home to clarify doubts and another time in the mid-term between sessions to assure their compliance.

- The interventions will be conducted at University of Alcala and Principe de Asturias Hospital (Spain) and will be delivered by an expert clinician with more than 8 years of expertise.
Control group
Active

Outcomes
Primary outcome [1] 299531 0
Spontaneous pain measured with Visual Analogue Scale (100mm)
Timepoint [1] 299531 0
4 measurements: baseline, immediately after (5 minute delay), 2 weeks and 4 weeks.
Secondary outcome [1] 327463 0
Pressure pain threshold by using an algometry device
Timepoint [1] 327463 0
4 measurements: baseline, immediately after (5 minute delay), 2 weeks and 4 weeks.
Secondary outcome [2] 327464 0
Multiplane cervical range of motion measured with cervical goniometer
Timepoint [2] 327464 0
4 measurements: baseline, immediately after (5 minute delay), 2 weeks and 4 weeks.
Secondary outcome [3] 327465 0
Elbow range of motion during Median Nerve Neurodynamic Test (ULNT1) using universal goniometer.
Timepoint [3] 327465 0
4 measurements: baseline, immediately after (5 minute delay), 2 weeks and 4 weeks.
Secondary outcome [4] 327466 0
Neck functionality measured by Neck Disability Index Questionnaire (NDI)
Timepoint [4] 327466 0
3 measurements: baseline, 2 and 4 weeks.
Secondary outcome [5] 332299 0
TSK- Tampa Sacle of Kinesiophobia (11 items)
Timepoint [5] 332299 0
Baseline, 2 and 4 weeks

Eligibility
Key inclusion criteria
- 18 y 65 years of range of age.
- Non-traumatic origin neck pain (checked and diagnosed by a specialist) with or without complaints to the head or upper limbs, following the Neck Pain Task Force definition about neck pain, of at least 4 weeks of duration. Then, neck pain patients will be categorized on the basis of the marks obtained in Douleur Neuropatique 4 questionnaire (DN4 spanish version).
- ULNT1 test (Neurodynamic Test for the median nerve) must be at least partially positive matching the affected side for subjects that have also DN4 positiv neuropathic pain. Reflexes abolition or slight diminution of sensitivity are not exclusion criteria, as well as herniated discs that do not produce strength decrease of the affected segment.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Previous spine surgeries
-Soft tissue neck surgery.
-Previous trauma over the neck (car accidents)
-Previous or current tumors
-To have received treatment with chemo/radiotherapy
-To have received physiotherapy in the past 6 weeks.
-Previous severe infections
-Diabetes.
-Cervical radiculopathy with strength deficits
-Cervical Mielopathy
-Spinal Stenosis if only provoke spasticity, gait disorders, sphyncter dysfunction, clonus and other severe neurologic deficits.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization created by a computer software (Epidat 'Registered Trademark' 4.2, Xunta de Galicia, Spain)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/04/2017
Date of last participant enrolment
Anticipated
30/05/2017
Actual
30/05/2017
Date of last data collection
Anticipated
Actual
27/06/2017
Sample size
Target
72
Accrual to date
Final
72
Recruitment outside Australia
Country [1] 8189 0
Spain
State/province [1] 8189 0
Madrid

Funding & Sponsors
Funding source category [1] 294460 0
Hospital
Name [1] 294460 0
Principe de Asturias University Hospital
Country [1] 294460 0
Spain
Funding source category [2] 295791 0
University
Name [2] 295791 0
University of Alcala. Physiotherapy Campus
Country [2] 295791 0
Spain
Primary sponsor type
Hospital
Name
Principe De Asturias University Hospital
Address
Carretera Alcala-Meco, s/n, 28805 Alcala de Henares, Madrid
Country
Spain
Secondary sponsor category [1] 293326 0
University
Name [1] 293326 0
University of Alcala. Physiotherapy Campus
Address [1] 293326 0
Edificio de Fisioterapia Campus Universitario
Ctra Madrid-Barcelona Km 33,6000 E-28871
Alcala de Henares , Madrid, E-28871
Country [1] 293326 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295892 0
Principe de Asturias University Hospital
Ethics committee address [1] 295892 0
Carretera Alcala-Meco, s/n, 28805 Alcala de Henares, Madrid.
Ethics committee country [1] 295892 0
Spain
Date submitted for ethics approval [1] 295892 0
Approval date [1] 295892 0
02/10/2013
Ethics approval number [1] 295892 0
OE 09/13

Summary
Brief summary
Subacute or chronic neck pain aetiology is not yet defined, but could be related to a sensitization process of nerve roots from the neck region.
- The objective is to compare short-term effectiveness of cervical lateral glides in isolation or as a component of the median nerve mobilization in patients with non-acute neck pain. In addition, to evaluate each technique separately.
- The main hypothesis is that cervical lateral glides as a component of the median nerve mobilization are more efficient in reducing pain (main outcome variable) compared to cervical lateral glides in isolation in both types of patients, neuropathic pain (patients with a DN4 evaluation equal or higher than 4) and nociceptive pain (DN4 less than 4)
- Single-blinded randomized clinical trial. Study takes part at University of Alcalá. 72 patients will be recruited, allocated randomly in 2 groups, will be likewise classified by the Neuropathic Pain Scale (DN4). A result equals to 4 or superior determines the neuropathic, or neurogenic if result is below 4 out of 10. Both types of patients will be submitted to both mobilization groups. Excluded patients with diabetes, previous spine surgeries,soft tissue neck surgery, previous neck trauma (car accidents,...), previous or current tumors, to have received treatment with chemo/radiotherapy, to have received physiotherapy in the past 6 weeks, severe infections, cervical radiculopathy with strength deficits, cervical mielopathy and spinal stenosis only if provokes spasticity, gait disorders, sphyncter dysfunction, clonus and other severe neurologic deficits.
- Group 1: cervical lateral glides associated to median nerve glide and home neurodynamic exercises. Group 2: cervical lateral glides in isolation and general neck mobility exercises.
- Outcomes will be gathered baseline, post-intervention, at 2 and 4 weeks. These measurements will be: spontaneous neck pain by using Visual Analogue Scale; pressure pain threshold in C6, median nerve at the elbow flexion fold and tibialis anterior muscle, measured with an algometry device; elbow extension range of motion during Upper Limb Neurodynamic Test 1 (median nerve); neck mobility, measured by cervical goniometer. Besides, information about neck function and fear of motion is taken at baseline, 2 weeks and at the end of the study using the Neck Disability Index and 11-item Tampa Scale of Kinesiophobia, respectively.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1084 1084 0 0
/AnzctrAttachments/371200-DICTAMEN COMITÉ ÉTICO DE INVESTIGACIÓN CLÍNICA.pdf (Ethics approval)

Contacts
Principal investigator
Name 67858 0
Mr Daniel Martin Vera
Address 67858 0
Universidad Europea de Madrid.

Tajo Street (no number). Villaviciosa de Odon. 28670. Madrid. Spain.
Country 67858 0
Spain
Phone 67858 0
+34691033859
Fax 67858 0
Email 67858 0
[email protected]
Contact person for public queries
Name 67859 0
Daniel Martin Vera
Address 67859 0
Universidad Europea de Madrid.

Tajo Street (no number). Villaviciosa de Odon. 28670. Madrid. Spain.
Country 67859 0
Spain
Phone 67859 0
+34691033859
Fax 67859 0
Email 67859 0
[email protected]
Contact person for scientific queries
Name 67860 0
Daniel Martin Vera
Address 67860 0
Universidad Europea de Madrid.

Tajo Street (no number). Villaviciosa de Odon. 28670. Madrid. Spain.
Country 67860 0
Spain
Phone 67860 0
+34691033859
Fax 67860 0
Email 67860 0
[email protected]

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