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Trial registered on ANZCTR


Registration number
ACTRN12619000546156
Ethics application status
Approved
Date submitted
2/04/2019
Date registered
8/04/2019
Date last updated
15/09/2020
Date data sharing statement initially provided
8/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Short-term effects of spinal thrust joint manipulation on postural sway in patients with chronic mechanical neck pain: a randomized controlled trial.
Scientific title
Short-term effects of spinal thrust joint manipulation on postural sway in patients with chronic mechanical neck pain: a randomized controlled trial.
Secondary ID [1] 297860 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neck pain 312234 0
Condition category
Condition code
Physical Medicine / Rehabilitation 310779 310779 0 0
Physiotherapy
Musculoskeletal 310806 310806 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Upper cervical spine manipulation; A single high velocity low amplitude (HVLA) thrust manipulation directed to the upper cervical spine (C1-C2) with the patient supine will be performed. For this technique, the patient’s left posterior arch of the atlas is contacted with the lateral aspect of the proximal phalanx of the therapist’s left second finger using a “cradle hold.” To localize the forces to the left C1-C2 articulation, secondary movements of extension, posterior-anterior shift, ipsilateral side-bend, and contralateral side-shift are used. While maintaining the secondary movements, the therapist perform a single HVLA thrust manipulation to the left atlanto-axial joint, using the combined thrusting primary movements of right rotation in an arc toward the underside eye and translation toward the table. This will be repeated using the same procedure but directed to the right C1-C2 articulation.

All the interventions will be carried out by an experienced physiotherapist with a five-year certification in spinal manipulation therapy, a degree in physiotherapy, and more than 9 years of clinical experience with patients. The application of the techniques will take no longer than 5 minutes and they will be supervised by another experienced physiotherapist.

Prior to the intervention, all participants will sign the informed consent.
Intervention code [1] 314095 0
Rehabilitation
Comparator / control treatment
Cervicothoracic spine manipulations; Patients in this group will receive three different spinal manipulations:
• Upper thoracic spine manipulation: patients are supine with the arms crossed over the chest and hands placed over the shoulders. The therapist place their chest at the level of the patient’s middle thoracic spine and grasp the patient’s elbows. Flexion of the thoracic spine is introduced until slight tension is felt in the tissues at the contact point. A distraction thrust joint manipulation in an upward direction is applied. If no popping sound is heard on the first attempt, the therapist reposition the patient, and perform a second manipulation. A maximum of 2 attempts are allowed on each patient.
• Cervicothoracic junction manipulation: this technique is applied bilaterally. Here we describe the procedure for a right C7-T1 thrust joint manipulation, that is, the contact is on the left side of the cervico-thoracic junction. The patient is prone with the head and neck rotated to the right. The therapist stood on the right side of the patient facing in a cephalic direction. The therapist’s left hand makes contact with the thumb on the left side of the spinous process of T1. The therapist’s right hand supports the head of the patient. The head/neck is gently laterally-flexed to the left, until slight tension is palpated in the tissues. A HVLA thrust is applied toward the patients’ right side. Again, a maximum of 2 attempts are allowed for each side.
• Mid-cervical spine manipulation: the subject is supine with the cervical spine in a neutral position. The index finger of the therapist apply a contact over the posterior-lateral aspect of the zygapophyseal joint of C3. The therapist cradle the patient's head with the other hand. Ipsilateral side-flexion and contralateral rotation to the targeted side is introduced until slight tension is perceived in the tissues at the contact point a HVLA thrust manipulation is directed upward and medially in the direction of the patient’s contralateral eye. Similarly, a maximum of 2 attempts are allowed for each side to obtain cavitation.

No period between manipulations.
Control group
Active

Outcomes
Primary outcome [1] 319628 0
Length of Center of Pressure path; measured using the Medicapteurs S-Plate platform (Balma, France) and associated S-Plate software.
Timepoint [1] 319628 0
At baseline and at fifteen days after treatment
Primary outcome [2] 319629 0
Area of center of pressure path; measured using the Medicapteurs S-Plate platform (Balma, France) and associated S-Plate software.
Timepoint [2] 319629 0
At baseline and at fifteen days after treatment
Primary outcome [3] 319630 0
Mean velocity of the center of pressure, measured using the Medicapteurs S-Plate platform (Balma, France) and associated S-Plate software.
Timepoint [3] 319630 0
At baseline and at fifteen days after treatment.
Secondary outcome [1] 368932 0
Displacement in X axis of the center of pressure, measured using the Medicapteurs S-Plate platform (Balma, France) and associated S-Plate software.
Timepoint [1] 368932 0
At baseline and at fifteen days after treatment.
Secondary outcome [2] 368933 0
Displacement in Y axis of the center of pressure, measured using the Medicapteurs S-Plate platform (Balma, France) and associated S-Plate software.
Timepoint [2] 368933 0
At baseline and at fifteen days after treatment
Secondary outcome [3] 368934 0
Change in neck pain. Measured with the Neck Pain Rating Scale (0 - 10)
Timepoint [3] 368934 0
At baseline and at fifteen days after treatment.

Eligibility
Key inclusion criteria
(1) Individuals with pain for more than 3 months; (2) aged 18 to 55 years old; (3) symptoms located in the area defined between the occipital bone and the first thoracic vertebra; (4) symptoms provoked by cervical movement or postures maintained over time.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Any contraindication for not undergoing spinal manipulation on the cervical level (fracture, osteoporosis, positive extension-rotation test or any symptoms of vertebrobasilar insufficiency); (2) a history of cervical whiplash; (3) a history of cervical spine surgery; (4) diagnosed cervical radiculopathy or polyneuropathy; (5) diagnosed fibromyalgia; 6) having undergone previous spinal manipulation treatment; or 7) be undergoing any treatment for neck pain at the time of the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2019
Actual
1/05/2019
Date of last participant enrolment
Anticipated
Actual
13/08/2019
Date of last data collection
Anticipated
Actual
28/08/2019
Sample size
Target
186
Accrual to date
Final
186
Recruitment outside Australia
Country [1] 21383 0
Spain
State/province [1] 21383 0
Almería

Funding & Sponsors
Funding source category [1] 302385 0
Self funded/Unfunded
Name [1] 302385 0
Raúl Romero del Rey
Country [1] 302385 0
Spain
Primary sponsor type
Individual
Name
Raúl Romero del Rey
Address
Clínica Ciudad de Almería
Calle Santa Bárbara, 3, 04009, Almería (Spain)
Country
Spain
Secondary sponsor category [1] 302276 0
None
Name [1] 302276 0
Address [1] 302276 0
Country [1] 302276 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303058 0
Committee of Ethics and Research at the University of Almeria
Ethics committee address [1] 303058 0
Carretera Sacramento S/N, La Cañada de San Urbano, 04120.
Ethics committee country [1] 303058 0
Spain
Date submitted for ethics approval [1] 303058 0
Approval date [1] 303058 0
22/06/2016
Ethics approval number [1] 303058 0

Summary
Brief summary
The aim of the study is to compare the effectiveness of high-velocity low-amplitude (HVLA) spinal manipulation in the atlantoaxial joint (C1-C2) with a combination of HVLA spinal manipulation on the cervicothoracic spine (C3-C4, C7-T1 and T6) and its influence on postural sway in patients with chronic mechanical neck pain.

Study Design: Randomized controlled trial.

Setting: Single rehabilitation center.

Participants: 186 patients diagnosed with chronic mechanic neck pain will be randomly divided into two groups: the upper cervical spine (UCS) manipulation group (n=93) and cervicothoracic spine (CTS) manipulations group (n=93).

Interventions: A single C1-C2 spinal manipulation technique will be performed in the group 1, whereas the group 2 will receive a combination of HVLA spinal manipulation on the cervicothoracic spine (C3-C4, C7-T1 and T6).

Hypothesis: The upper cervical spine manipulation has a greater influence on postural sway in patients with chronic mechanical neck pain
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92314 0
Mr Raúl Romero del Rey
Address 92314 0
Clínica Ciudad de Almería
Calle Santa Bárbara, 3, 04009, Almería (Spain)
Country 92314 0
Spain
Phone 92314 0
+34 6 4512 7620
Fax 92314 0
Email 92314 0
[email protected]
Contact person for public queries
Name 92315 0
Raúl Romero del Rey
Address 92315 0
Clínica Ciudad de Almería
Calle Santa Bárbara, 3, 04009, Almería (Spain)
Country 92315 0
Spain
Phone 92315 0
+34 6 4512 7620
Fax 92315 0
Email 92315 0
[email protected]
Contact person for scientific queries
Name 92316 0
Raúl Romero del Rey
Address 92316 0
Clínica Ciudad de Almería
Calle Santa Bárbara, 3, 04009, Almería (Spain)
Country 92316 0
Spain
Phone 92316 0
+34 6 4512 7620
Fax 92316 0
Email 92316 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.