Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000711910
Ethics application status
Approved
Date submitted
6/02/2020
Date registered
30/06/2020
Date last updated
10/12/2020
Date data sharing statement initially provided
30/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of specific neck exercise and manual therapy for chronic mechanical neck pain
Scientific title
Effectiveness of specific neck exercise and manual therapy for chronic mechanical neck pain
Secondary ID [1] 300229 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mechanical chronic neck pain 315793 0
Condition category
Condition code
Musculoskeletal 314081 314081 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manual therapy:

Participants will receive 4 (once a week) 30 minute sessions of manual therapy including the following techniques which will be applied at the discretion of the physiotherapists .
- Grade II-III segmental postero-anterior and/or antero-posterior mobilisations following the movement plane of the cervical zygapophyseal joints (downslope or upslope). These will be applied to pain reproducing and adjacent cervical segments.
- Pressure maintained suboccipital inhibition manual technique.
- Cervical longitudinal traction.
- Grade II-III segmental postero-anterior mobilisations to the upper thoracic spine
Intervention code [1] 316502 0
Rehabilitation
Intervention code [2] 317059 0
Treatment: Other
Comparator / control treatment
Specific neck exercise:

Participants will undertake a programme of neck specific exercises. The programme will involve 4 physiotherapist-led sessions (once a week) and daily home exercises for 4 weeks (approximately 20 minutes/day). The full exercise programme is as follows:

A) Neck Flexor Training:

Block 1. Re-education of CCF movement pattern

Block 2. Holding capacity

Block 3. Interaction between the deep/superficial cervical flexors

Block 4. Co-contraction of the deep cervical flexors/extensors

Block 5. Strength/endurance of the cervical flexors


B) Neck Extensor Training

Block 1. Re-education of extension movement pattern

Block 2. Co-contraction of the deep cervical flexors/extensors

Block 3. Strength/endurance of the cervical extensors

Adherence will be monitored by asking participants to submit a completed sheet that outlines the days when they have performed the provided exercise programme.
Control group
Active

Outcomes
Primary outcome [1] 322471 0
Global rating of change scale: participants wil be asked to rate the perceived treatment effect using the global rating of change scale (GROC). This is a 15 point scale where change is rated from -7 (a very great deal worse) through 0 (no change) to +7 (a very great deal better).
Timepoint [1] 322471 0
2 weeks after treatment commencement; within 48 hours of the last treatment completion; 12 weeks after last treatment completion.
Primary outcome [2] 322472 0
Neck disability Index questionnaire
Timepoint [2] 322472 0
Baseline; 2 weeks after treatment commencement; within 48 hours of the last treatment completion; 12 weeks after last treatment completion.
Primary outcome [3] 322473 0
Patient specific functional scale: this is a patient identified self-report questionnaire that measures general activity limitations. The scale ranges from 0 (unable to perform) to 10 (able to perform the activity at the level prior to injury). The patient reports three activities and rates each activity from 0 to 10 which are averaged for a composite score.
Timepoint [3] 322473 0
Baseline; 2 weeks after treatment commencement; within 48 hours of the last treatment completion; 12 weeks after last treatment completion.
Secondary outcome [1] 378638 0
The Short Form Health Survey (SF36) questionnaire.
Timepoint [1] 378638 0
Baseline; 2 weeks after treatment commencement and within 48 hours of the last treatment completion
Secondary outcome [2] 378639 0
European Quality of Life - 5 Dimensions (EQ-5D) questionnaire
Timepoint [2] 378639 0
Baseline; 2 weeks after treatment commencement and within 48 hours of the last treatment completion
Secondary outcome [3] 378640 0
Tampa scale of Kinesophobia
Timepoint [3] 378640 0
Baseline; 2 weeks after treatment commencement and within 48 hours of the last treatment completion
Secondary outcome [4] 378641 0
Maximum pain during last week on a 0-10 (no pain to worst imaginable) numeric pain rating scale.
Timepoint [4] 378641 0
Baseline; 2 weeks after treatment commencement; within 48 hours of the last treatment completion; 12 weeks after last treatment completion.
Secondary outcome [5] 378642 0
Maximum pain during last 24 hours on a 0-10 (no pain to worst imaginable) numeric pain rating scale.
Timepoint [5] 378642 0
Baseline; 2 weeks after treatment commencement; within 48 hours of the last treatment completion; 12 weeks after last treatment completion.
Secondary outcome [6] 378645 0
Maximum neck range of movement in sitting measured using '3D range of motion’ application in an iphone.. This application uses the built-in gyroscope and accelerometer function of the smartphone as angular measurement tools. The iphone is fastened securely on the forehead by means of an iPhone holder with a rigid Velcro strap.
Timepoint [6] 378645 0
Baseline; 2 weeks after treatment commencement and within 48 hours of the last treatment completion
Secondary outcome [7] 378646 0
Craniocervical flexion test performance
Timepoint [7] 378646 0
Baseline; 2 weeks after treatment commencement and within 48 hours of the last treatment completion
Secondary outcome [8] 379660 0
Deep cervical extensor test performance
Timepoint [8] 379660 0
Baseline; 2 weeks after treatment commencement and within 48 hours of the last treatment completion
Secondary outcome [9] 379661 0
Presence of pain during neck active movements (flexion, extension, side flexion and rotation). Participants will be asked to move their head into flexion, extension, side flexion and rotation, and they will be asked to report if they experience pain during each of these movements.
Timepoint [9] 379661 0
Baseline; 2 weeks after treatment commencement and within 48 hours of the last treatment completion
Secondary outcome [10] 381120 0
Participants will be asked if treatment has met their expectations with the following question: “How would you describe how you feel now compared to what you expected?”; participants will have to chose from the following responses:
- “I have more pain than I expected”
- “I have less pain than I expected”
- “I have the amount of pain I expected”
Timepoint [10] 381120 0
Within 48 hours of the last treatment completion.
Secondary outcome [11] 381121 0
Pressure pain threshold (PPT) will be measured:
1. Bilaterally over the upper trapezius muscle and C5-6 joints in the cervical spine
2. Over the most painful point in the neck as described by the patient
PPT will be measured with a handheld algometer of 1 cm diameter and will be defined as the minimum pressure where pressure sensation becomes painful. Three measures will be taken at each site and the average of the three calculated to represent PPT at each site.
Timepoint [11] 381121 0
Baseline and immediately after the first treatment session.

Eligibility
Key inclusion criteria
- Primary complaint of neck pain.
- Non-traumatic (insidious) history of onset.
- Mechanical in nature i.e. pain has clear aggravating and easing positions or movements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Radicular pain.
- Referral to other health professional to exclude red flags not required.
- Signs of central hyperexcitability (e.g. widespread, non-anatomical/nonspecific distribution of pain; stimulus-independent spontaneous pain).
- Whiplash injury.
- Have or are awaiting neck surgery.
- Inflammatory disease or spinal condition.

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)
The treating therapist will open an opaque sealed envelope (one for each participant) which has been prepared in advance by a third party and contains the treatment allocation
of that participant
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
It is anticipated that approximately 80 subjects will be required. Once data collection is completed, a quantitative analysis will be performed. The effectiveness of the treatments will be analysed in relation to the recorded primary and secondary outcome measures,

Furthermore, the predictive value of baseline measures on treatment outcome will be established.. In addition to the baseline measures described previously in 'step 4: outcome measures', the following measures will be taken in order to test their predictive value with regards to treatment effectiveness:

1: If pain follows a compression (e,.g. aggravated by extension, ipsilateral rotation and ipsilateral side flexion of the neck) or stretch (flexion, contralateral rotation and contralateral side flexion of the neck) pattern
2. Test of movement pattern of neck flexion
3. Test of movement pattern of neck extension
4. Test of the subocciptal muscles
5. Presence of hypomobility and pain during passive manual testing of the cervical spine
6. Number of physiotherapy or osteopathy treatment sessions in the last 12 months

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/07/2020
Actual
6/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
10
Final
Recruitment outside Australia
Country [1] 22317 0
Spain
State/province [1] 22317 0

Funding & Sponsors
Funding source category [1] 304660 0
University
Name [1] 304660 0
University of the Basque Country UPV/EHU
Country [1] 304660 0
Spain
Primary sponsor type
University
Name
University of the Basque Country UPV/EHU
Address
Faculty of Medicine and Nursing
University of the Basque Country
Barrio Sarriena, s/n Leioa 
48940 Spain
Country
Spain
Secondary sponsor category [1] 304964 0
None
Name [1] 304964 0
Address [1] 304964 0
Country [1] 304964 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305080 0
University of the Basque Country Research Ethics Committee.
Ethics committee address [1] 305080 0
Ethics committee country [1] 305080 0
Spain
Date submitted for ethics approval [1] 305080 0
Approval date [1] 305080 0
25/09/2019
Ethics approval number [1] 305080 0

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

Contacts
Principal investigator
Name 99198 0
Mr Iker Villanueva Ruiz
Address 99198 0
Faculty of Medicine and Nursing
University of the Basque Country
Barrio Sarriena, s/n Leioa 
48940
Country 99198 0
Spain
Phone 99198 0
+34 943018000
Fax 99198 0
Email 99198 0
[email protected]
Contact person for public queries
Name 99199 0
Iker Villanueva Ruiz
Address 99199 0
Faculty of Medicine and Nursing
University of the Basque Country
Barrio Sarriena, s/n Leioa 
48940
Country 99199 0
Spain
Phone 99199 0
+34 943018000
Fax 99199 0
Email 99199 0
[email protected]
Contact person for scientific queries
Name 99200 0
Iker Villanueva Ruiz
Address 99200 0
Faculty of Medicine and Nursing
University of the Basque Country
Barrio Sarriena, s/n Leioa 
48940
Country 99200 0
Spain
Phone 99200 0
+34 943018000
Fax 99200 0
Email 99200 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.