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Trial registered on ANZCTR


Registration number
ACTRN12620000163909
Ethics application status
Approved
Date submitted
28/11/2019
Date registered
17/02/2020
Date last updated
12/03/2020
Date data sharing statement initially provided
17/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Do clinical and neurophysiological measures predict treatment response to manual therapy in patients with non-specific neck pain?
Scientific title
Do clinical and neurophysiological measures predict treatment response to manual therapy in patients with non-specific neck pain?
Secondary ID [1] 299500 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-traumatic, mechanical neck pain without radiculopathy 314776 0
Condition category
Condition code
Musculoskeletal 313109 313109 0 0
Other muscular and skeletal disorders
Neurological 313977 313977 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive 4 sessions of 45 minutes (1 session per week) of manual therapy each, with the participant positioned in supine or prone. The clinician will be able to choose from the following manual therapy techniques according to their clinical reasoning:
1. Cervical passive mobilisations: oscillatory movements of the cervical vertebra
2. Soft tissue massage: massage over the neck musculature
3. Trigger point manual therapy: sustained pressure applied over symptomatic trigger points
Treatment will be delivered by a Physiotherapist at a primary care physiotherapy clinic. Attendance will be monitored with a session attendance checklist.
Intervention code [1] 315783 0
Rehabilitation
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321649 0
Temporal summation of pain (TSP) using an electrical stimulus. On a 0-100 numeric pain rating scale, the participant will be asked to rate the pain produced by an electrical stimulus.. After a 1 minute rest period the same current will be administered to the participant and he/she will be asked to rate again the pain produced by the same stimulus. The change between the two reported pain ratings will be used as a measure of the participant´s TSP.
Timepoint [1] 321649 0
At baseline and after last treatment (within 24 hours from last treatment session).
Primary outcome [2] 321650 0
Conditioned pain modulation: pressure pain threshold (PPT) will be measured over the angle of the upper fibers of the upper trapezius (approximately 5 to 8 cm superomedial to the superior angle of the scapula) ipsilateral to neck pain, or if pain is bilateral, of the dominant hand. 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. Then, the participant will be asked to immerse the contralateral foot in water kept at 10°C for a maximum of 2 minutes. Pressure pain threshold will be measured again in the same location immediately after the foot has been removed from the water.
Timepoint [2] 321650 0
At baseline and after last treatment (within 24 hours from last treatment session).
Primary outcome [3] 321651 0
Participants will be asked to rate their 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 great deal better).
Timepoint [3] 321651 0
After last treatment (within 24 hours from last treatment session).
Secondary outcome [1] 375751 0
Pain during neck movements. Patients will be asked to move their neck into flexion, extension, side flexion and rotation. They will be asked to rate on a 0-100 scale the pain experienced during these movements.
Timepoint [1] 375751 0
.At baseline and after last treatment (within 24 hours from last treatment session).
Secondary outcome [2] 375752 0
Pressure pain threshold (PPT): will be measured with a handheld algometer of 1 cm diameter. PPT will be defined as the minimum pressure where pressure sensation becomes painful. PPT will be measured bilaterally over the angle of the upper fibers of trapezius (approximately 5 to 8 cm superomedial to the superior angle of the scapula) and the tibialis anterior (2.5 cm lateral and 5cm inferior to the anterior tibial tuberosity) muscles. Three measures will be taken in each location, with a one minute rest period in between, and the average of the three will be used for analysis.
Timepoint [2] 375752 0
.At baseline and after last treatment (within 24 hours from last treatment session).
Secondary outcome [3] 375753 0
Maximum and average pain intensity during the previous 24 h recorded using a numeric pain rating scale (0-100)
Timepoint [3] 375753 0
.At baseline and after last treatment (within 24 hours from last treatment session).
Secondary outcome [4] 375754 0
Patient Specific Functional Scale: 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 3 activities and rates each activity from 0 to 10, which are averaged for a composite score.
Timepoint [4] 375754 0
.At baseline and after last treatment (within 24 hours from last treatment session).
Secondary outcome [5] 375755 0
Neck Disability Index questionnaire.
Timepoint [5] 375755 0
.At baseline and after last treatment (within 24 hours from last treatment session).
Secondary outcome [6] 375756 0
Tampa Scale for Kinesiophobia.
Timepoint [6] 375756 0
.At baseline and after last treatment (within 24 hours from last treatment session).
Secondary outcome [7] 375757 0
Pain Catastrophizing Scale.
Timepoint [7] 375757 0
.At baseline and after last treatment (within 24 hours from last treatment session).
Secondary outcome [8] 375758 0
Patient´s expectation regarding the offered treatment will be assessed by asking participants to rate their agreement with the following statement with a 0-100 numeric rating scale: “I am confident that this treatment can alleviate my complaint” .
Timepoint [8] 375758 0
Baseline
Secondary outcome [9] 375759 0
Participant 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 [9] 375759 0
After last treatment (within 24 hours from last treatment session).
Secondary outcome [10] 375760 0
Area of pain: painful area drawn using a digital pain mapping device.
Timepoint [10] 375760 0
After last treatment (within 24 hours from last treatment session).
Secondary outcome [11] 377410 0
Pain aggravating factor: the patient will be asked whether their pain is mostly aggravated by a posture or a movement. According to this, pain will be classified as either postural or movement associated.
Timepoint [11] 377410 0
Baseline

Eligibility
Key inclusion criteria
- Primary complaint of neck pain
- Non-traumatic (insidious) history of onset
- Mechanical in nature i.e. pain has clear mechanical aggravating and easing positions or movements (e.g. neck rotation and extension)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Neurological deficit (either sensory or motor) or radicular pain
- Referral to other health professional to exclude red flags required
- Widespread, non-anatomical/nonspecific distribution of pain; stimulus-independent spontaneous pain
- Cold hyperalgesia
- Whiplash injury
- Have or are awaiting neck surgery
- Inflammatory disease or spinal condition

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
People administering the treatment will be blind to the baseline measures e.g. central nervous system hyperexcitability status.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A pilot study consisting of 15 subjects will be carried out to test the study methodology and also obtain context specific estimates of the effect size. Obtained effect sizes will be used in a power calculation to determine the final sample size. It is estimated that approximately 60 subjects will be required for the study.

Once data collection is completed, a quantitative analysis will be performed. The effectiveness of the treatment will be analysed in relation to the recorded primary and secondary outcome measures, and the correlation between changes in symptoms and changes in measures of central nervous hyperexcitability will be assessed. In addition, the ability of baseline clinical and neurophysiological measures to predict treatment outcome will be explored.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21916 0
Spain
State/province [1] 21916 0
Bizkaia

Funding & Sponsors
Funding source category [1] 303999 0
University
Name [1] 303999 0
University of the Basque Country UPV/EHU
Address [1] 303999 0
Department of Physiolog, Faculty of Medicine and Nursing, University of the Basque Country, Barrio Sarriena, s/n Leioa, 48940, Spain 
Country [1] 303999 0
Spain
Primary sponsor type
University
Name
University of the Basque Country UPV/EHU
Address
Department of Physiolog, Faculty of Medicine and Nursing, University of the Basque Country, Barrio Sarriena, s/n Leioa, 48940, Spain 
Country
Spain
Secondary sponsor category [1] 304172 0
None
Name [1] 304172 0
Address [1] 304172 0
Country [1] 304172 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304492 0
University of the Basque Country Research Ethics Committee.
Ethics committee address [1] 304492 0
University of the Basque Country, Barrio Sarriena, s/n Leioa, 48940 Spain 
Ethics committee country [1] 304492 0
Spain
Date submitted for ethics approval [1] 304492 0
Approval date [1] 304492 0
03/06/2019
Ethics approval number [1] 304492 0

Summary
Brief summary
The primary aims of the study are to establish:
1. The extent to which baseline measures of central nervous system hyperexcitability affect clinical outcome in patients with neck pain.
2. The extent to which clinical outcome is associated with the change in central nervous system hyperexcitability.

The secondary aims will be to establish:
1. The extent to which patient expectation is associated with clinical outcome.

The hypotheses are:
1. There will be an association between baseline measures of central nervous system hyperexcitability and clinical outcome in patients with neck pain.
2. Clinical outcome will be associated with the change in central nervous system hyperexcitability
3. Patient expectation will be associated with clinical outcome
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97138 0
Mr Josu Zabala Mata
Address 97138 0
Department of Physiolog, Faculty of Medicine and Nursing, University of the Basque Country, Barrio Sarriena, s/n Leioa, 48940, Spain 
Country 97138 0
Spain
Phone 97138 0
+34606282577
Fax 97138 0
Email 97138 0
josuzabala@yahoo.es
Contact person for public queries
Name 97139 0
Mr Josu Zabala Mata
Address 97139 0
Department of Physiolog, Faculty of Medicine and Nursing, University of the Basque Country, Barrio Sarriena, s/n Leioa, 48940, Spain 
Country 97139 0
Spain
Phone 97139 0
+34606282577
Fax 97139 0
Email 97139 0
josuzabala@yahoo.es
Contact person for scientific queries
Name 97140 0
Mr Josu Zabala Mata
Address 97140 0
Department of Physiolog, Faculty of Medicine and Nursing, University of the Basque Country, Barrio Sarriena, s/n Leioa, 48940, Spain 
Country 97140 0
Spain
Phone 97140 0
+34 946017947
Fax 97140 0
Email 97140 0
josuzabala@yahoo.es

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 other documents available
Summary results
No Results