Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000490279
Ethics application status
Approved
Date submitted
9/02/2018
Date registered
4/04/2018
Date last updated
4/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparative study between cervicothoracic manipulation techniques and upper cervical spine manipulation in patients with chronic mechanical neck pain.
Scientific title
A comparative study between cervicothoracic manipulation techniques and upper cervical spine manipulation and their effectiveness in the cervical range of motion, neck pain and disability in patients with chronic mechanical neck pain.
Secondary ID [1] 294014 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Limitation of the cervical range of motion 306532 0
Neck pain 306533 0
Cervical disability 306534 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305639 305639 0 0
Physiotherapy
Musculoskeletal 305640 305640 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be carried out in single rehabilitation center.

The intervention was performed by a physiotherapist with more than 5 years of experience in manual therapy.

Intervention: Upper cervical spine manipulation; A single HVLA thrust manipulation directed to the upper cervical spine (C1-C2) with the patient supine was performed. For this technique, the patient’s left posterior arch of the atlas was 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 levers of extension, posterior-anterior shift, ipsilateral side-bend, and contralateral side-shift were used. While maintaining the secondary levers, the therapist performed a single HVLA thrust manipulation to the left atlanto-axial joint, using the combined thrusting primary levers of right rotation in an arc toward the underside eye and translation toward the table. This was repeated using the same procedure but directed to the right C1-C2 articulation.

Data Collection Protocol: The participants were evaluated and intervened in three different sessions (1st session: after signing the informed consent, 2nd session: 7 days after the start, 3rd session: 15 days after the start). The intervention was carried out five minutes after the evaluation and the re-evaluation process began five minutes after the intervention. The order carried out during the data collection protocol was always the same in each of the sessions held both before and after the intervention, with the exception of the disability, which was collected only in the first and the last session. In each session the range of motion was measured first and then the neck pain, before and after the intervention.
Prior to the intervention, all participants will sign the informed consent.
Intervention code [1] 300286 0
Rehabilitation
Comparator / control treatment
Cervicothoracic spine manipulations; Patients in this group received three different spinal manipulations:
• Upper thoracic spine manipulation: patients were supine with the arms crossed over the chest and hands placed over the shoulders. The therapist placed their chest at the level of the patient’s middle thoracic spine and grasped the patient’s elbows. Flexion of the thoracic spine was introduced until slight tension was felt in the tissues at the contact point. A distraction thrust joint manipulation in an upward direction was applied. If no popping sound was heard on the first attempt, the therapist repositioned the patient, and performed a second manipulation. A maximum of 2 attempts were allowed on each patient.
• Cervicothoracic junction manipulation: this technique was applied bilaterally. Here we describe the procedure for a right C7-T1 thrust joint manipulation, that is, the contact was on the left side of the cervico-thoracic junction. The patient was 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 was applied toward the patients’ right side. Again, a maximum of 2 attempts were allowed for each side.
• Mid-cervical spine manipulation: the subject was supine with the cervical spine in a neutral position. The index finger of the therapist applied a contact over the posterior-lateral aspect of the zygapophyseal joint of C3. The therapist cradled the patient's head with the other hand. Ipsilateral side-flexion and contralateral rotation to the targeted side was introduced until slight tension was perceived in the tissues at the contact point a HVLA thrust manipulation was directed upward and medially in the direction of the patient’s contralateral eye. Similarly, a maximum of 2 attempts were allowed for each side to obtain cavitation.

The duration of the study, the number of sessions and the data collection protocol followed in this group were the same as in the experimental group.
Control group
Active

Outcomes
Primary outcome [1] 304746 0
Change in cervical range of motion. Measured with the CROM (Cervical Range of Motion)
Timepoint [1] 304746 0
Measured pre- and post- each session (day 1, day 7 and day 15), with day 15 as the primary timepoint.
Primary outcome [2] 304747 0
Change in neck pain. Measured with the Neck Pain Rating Scale (0 - 10)
Timepoint [2] 304747 0
Measured pre- and post- each session (day 1, day 7 and day 15), with day 15 as the primary timepoint.
Secondary outcome [1] 343004 0
Neck disability. Measured with the Neck Disability Index (0 - 50)
Timepoint [1] 343004 0
Measured before the first session (day 1) and after the final session (day 15).

Eligibility
Key inclusion criteria
(a) age between 18-55 years; (b) subject diagnosed with chronic mechanical neck pain (> 3 months of evolution); (c) negative result in orthopedic diagnostic tests (Spurling test, Jackson test, Valsalva test, Klein test, Sharp-Purser test).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) surgical history in cervical and / or thoracic spine; (b) signs of vertebro-basilar insufficiency; (c) diagnosis of disc pathology; (d) diagnosis of fibromyalgia or any rheumatic disease; (e) pharmacological treatment (analgesics, NSAIDs, anxiolytics, antidepressants, etc.); (f) present some contraindication to the thrust techniques under study (tumors, infections, rheumatism, fractures, osteoporosis, psychic alterations, congenital malformations, neurological pathologies, etc.)

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/11/2016
Date of last participant enrolment
Anticipated
Actual
19/09/2017
Date of last data collection
Anticipated
Actual
10/10/2017
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 9575 0
Spain
State/province [1] 9575 0
Almería

Funding & Sponsors
Funding source category [1] 298638 0
Self funded/Unfunded
Name [1] 298638 0
Raúl Romero del Rey
Country [1] 298638 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] 297810 0
None
Name [1] 297810 0
Address [1] 297810 0
Country [1] 297810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299598 0
Ethics Committee of the University of Almeria
Ethics committee address [1] 299598 0
Ethics committee country [1] 299598 0
Spain
Date submitted for ethics approval [1] 299598 0
Approval date [1] 299598 0
22/06/2016
Ethics approval number [1] 299598 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80974 0
Mr Raúl Romero del Rey
Address 80974 0
Clínica Ciudad de Almería.
Calle Santa Bárbara, 3, 04009, Almería (Spain)
Country 80974 0
Spain
Phone 80974 0
+34 6 4512 7620
Fax 80974 0
Email 80974 0
[email protected]
Contact person for public queries
Name 80975 0
Raúl Romero del Rey
Address 80975 0
Clínica Ciudad de Almería.
Calle Santa Bárbara, 3, 04009, Almería (Spain)
Country 80975 0
Spain
Phone 80975 0
+34 6 4512 7620
Fax 80975 0
Email 80975 0
[email protected]
Contact person for scientific queries
Name 80976 0
Raúl Romero del Rey
Address 80976 0
Clínica Ciudad de Almería.
Calle Santa Bárbara, 3, 04009, Almería (Spain)
Country 80976 0
Spain
Phone 80976 0
+34 6 4512 7620
Fax 80976 0
Email 80976 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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