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Trial registered on ANZCTR


Registration number
ACTRN12613001000796
Ethics application status
Approved
Date submitted
4/09/2013
Date registered
10/09/2013
Date last updated
18/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative short-term effects of two thoracic spinal manipulation techniques in subjects with chronic mechanical neck pain: a randomized controlled trial.
Scientific title
Comparative short-term effects of two thoracic spinal manipulation techniques (dog technique and toggle-recoil technique) on neck pain perception and cervical mobility in subjects with chronic mechanical neck pain: A randomized controlled trial.
Secondary ID [1] 283136 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Self-perceived neck pain 289987 0
Cervical range of motion 289988 0
Sensitivity to mechanical pressure 289989 0
Condition category
Condition code
Musculoskeletal 290370 290370 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 290371 290371 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention technique in the toggle-recoil group

The toggle-recoil technique was performed, as modified by Mc Timoney. The participant was lying on the stomach. The therapist crossed the forearms and contacted the transverse processes of the fourth thoracic vertebrae (T4) with the pisiform bones. While the subject was breathing out the therapist delivered a fast posterior-anterior impulse to achieve the manipulative thrust. The thrust should be short range and fast.

A single spinal manipulation technique was performed to participants in this group.

The treatment protocol lasted for about two minutes in this group.
Intervention code [1] 287863 0
Rehabilitation
Intervention code [2] 287864 0
Treatment: Other
Comparator / control treatment
Intervention technique in the dog-technique group

The subject was placed in the supine position with both arms crossed over the chest. The technique was performed as follows, being the fourth thoracic vertebrae (T4) the targeted vertebrae.
The caudal hand of the therapist located T4 bilaterally with a “fist-contact”. Then, the therapist placed the other hand against the subject’s elbows and added flexion and posterior slide movements to reduce the slack. The subject was asked to breathe in and while breathing out the therapist used the body to push through the subject’s arms in an anterior to posterior direction impulse to deliver the high-velocity low-amplitude thrust.

Subjects in this group received a single spinal manipulation.

Intervention time in this group lasted for about two minutes.
Control group
Active

Outcomes
Primary outcome [1] 290399 0
Improvement in self-perceived neck pain by at least 35%

A Visual Analogue Scale (VAS) was used to assess self-reported pain. The VAS is considered to be a valid, effective, sensitive, easy to use, and reproducible method to assess acute and chronic pain. In addition, VAS is an accurate tool to detect immediate and clinically relevant changes in pain perception.
The VAS consists of an horizontal 100mm line, that ranges from 0 (no pain) to 100 mm (severe pain). The subject was asked about the current level of pain in rest position.
Timepoint [1] 290399 0
First evaluation was made immediately after intervention (two minutes)

Second evaluation was made 20 minutes after intervention
Primary outcome [2] 290400 0
Improvement in Cervical Mobility by 25%

Cervical mobility was measured using the Cervical Range of Motion Basic (CROM) tool (Performance Attainment Associates, St Paul, MN, USA).
The participant was seated in a chair with no back rest and both feet on the ground. Measurements were taken in the following order: flexion, extension, right and left side bending, right and left rotation. The CROM has been shown to have a high inter-examiner reliability, between 0.8 and 0.87. In addition, it is an easy tool to use and requires only one evaluator.
Timepoint [2] 290400 0
First measurement was made immediately after intervention (2 minutes)

Second evaluation was made 20 minutes after intervention
Secondary outcome [1] 304428 0
Decrease of Mechanosensitivity in the fourth thoracic vertebra (T4), fourth cervical vertebra (C4) and upper trapezius muscle by at least 20%

The pressure pain threshold (PPT) is defined as the minimum amount of pressure needed to evoke discomfort or pain.To measure PPT, an analogue pressure algometer (Baseline, FEI Inc., White Plains, NY, USA) was used.

Pressure algometry was carried out with the subject seated, in the spinous process of the fourth cervical and thoracic vertebraes (C4 and T4), and in the area described for the location of the tense band of the upper trapezius muscle, in the mid-point of the distance between the acromion and the seventh cervical vertebra.

Following previous references, the mean of three measurements was taken as the reference value. Pressure algometry has proven to be a valid tool and has shown an inter-examiner reliability of 0.91
Timepoint [1] 304428 0
First measurement was made immediately after intervention (about 2 minutes)

Second measurement was made 20 minutes after intervention

Eligibility
Key inclusion criteria
(a) aged between 18 and 60 years; (b) a minimum of a 3-month history of non specific neck pain. No minimum intensity of pain was specified; (c) neck pain not to be due to any known cause, such as fracture or infection; (d) cervical pain was present with increased pain on one of the following criteria; with maintained posture, with movement and/or with palpation of the spinal muscles; (e) perceived discomfort with joint pressure.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) current use of any medication (anti-inflammatories, analgesics) which might interfere with the results of the study; (b) the presence of rheumatoid arthritis or other inflammatory diseases; (c) the presence of any neurological conditions; (d) any bone pathology or history of tumours; (e) whiplash injury; (f) having received SM in the previous 2 months before data collection; (g) two or more positive signs of compressed nerves, for instance, changes in sensation, myotomal weakness in the arms, or alteration in deep tendon reflexes; (h) previous surgery on the spine; (i) any contraindication to perform spinal manipulation; and (j) subjects who did not achieve cavitation after two thrust attempts.

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)
Subjects of the study were recruited from a private clinical consultancy.

The therapist in charge of the treatment was informed of the group allocation of every subject through a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment allocation was made using a random sequence that was obtained using free software and a randomized number table designed by an external office (www.randomized.com). An outside collaborator safeguarded the randomized sequence from all those participating in the study
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2012
Actual
1/05/2012
Date of last participant enrolment
Anticipated
7/09/2012
Actual
27/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 5382 0
Spain
State/province [1] 5382 0
Pais Vasco

Funding & Sponsors
Funding source category [1] 287888 0
University
Name [1] 287888 0
Department of Physiotherapy.
Faculty of Nursing, Physiotherapy and Podiatry
University of Sevilla, Spain
Country [1] 287888 0
Spain
Primary sponsor type
University
Name
Department of Physiotherapy. Faculty of Nursing, Physiotherapy and Podiatry. University of Sevilla, Spain
Address
Department of Physiotherapy
University of Sevilla, Spain

C/ Avicena s/n, 41009 Sevilla, Spain
Country
Spain
Secondary sponsor category [1] 286616 0
None
Name [1] 286616 0
Address [1] 286616 0
Country [1] 286616 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289829 0
Research Ethics Committe University of Sevilla, Spain
Ethics committee address [1] 289829 0
Ethics committee country [1] 289829 0
Spain
Date submitted for ethics approval [1] 289829 0
02/02/2012
Approval date [1] 289829 0
20/03/2012
Ethics approval number [1] 289829 0
NONE

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

Contacts
Principal investigator
Name 42634 0
Dr Amaloha Casanova-Mendez
Address 42634 0
ANZOATEGUI Fisioterapia
Pl/El Desierto, 2 Bajo Izda.
48901 Barakaldo (Vizcaya)
Country 42634 0
Spain
Phone 42634 0
+34 946562499
Fax 42634 0
Email 42634 0
[email protected]
Contact person for public queries
Name 42635 0
Angel Oliva-Pascual-Vaca
Address 42635 0
Physiotherapy Department.
Faculty of Nursing, Physiotherapy and Podiatry, University of Sevilla, Sevilla, Spain
c/ Avicena s/n, 41009 Sevilla, Spain.
Country 42635 0
Spain
Phone 42635 0
+34954486528
Fax 42635 0
Email 42635 0
[email protected]
Contact person for scientific queries
Name 42636 0
Angel Oliva-Pascual-Vaca
Address 42636 0
Physiotherapy Department.
Faculty of Nursing, Physiotherapy and Podiatry, University of Sevilla, Sevilla, Spain
c/ Avicena s/n, 41009 Sevilla, Spain.
Country 42636 0
Spain
Phone 42636 0
+34954486528
Fax 42636 0
Email 42636 0
[email protected]

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