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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
1/06/2023
Date data sharing statement initially provided
17/02/2020
Date results information initially provided
1/06/2023
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?
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Scientific title
Do clinical and neurophysiological measures predict treatment response to manual therapy in patients with non-specific neck pain?
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Secondary ID [1]
299500
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-traumatic, mechanical neck pain without radiculopathy
314776
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Condition category
Condition code
Musculoskeletal
313109
313109
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0
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Other muscular and skeletal disorders
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Neurological
313977
313977
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
315783
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Rehabilitation
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
321649
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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.
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Assessment method [1]
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Timepoint [1]
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At baseline and after last treatment (within 24 hours from last treatment session).
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Primary outcome [2]
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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.
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Assessment method [2]
321650
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Timepoint [2]
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At baseline and after last treatment (within 24 hours from last treatment session).
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Primary outcome [3]
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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).
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Assessment method [3]
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Timepoint [3]
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After last treatment (within 24 hours from last treatment session).
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Secondary outcome [1]
375751
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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.
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Assessment method [1]
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Timepoint [1]
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.At baseline and after last treatment (within 24 hours from last treatment session).
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Secondary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
375752
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.At baseline and after last treatment (within 24 hours from last treatment session).
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Secondary outcome [3]
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Maximum and average pain intensity during the previous 24 h recorded using a numeric pain rating scale (0-100)
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Assessment method [3]
375753
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Timepoint [3]
375753
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.At baseline and after last treatment (within 24 hours from last treatment session).
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Secondary outcome [4]
375754
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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.
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Assessment method [4]
375754
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Timepoint [4]
375754
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.At baseline and after last treatment (within 24 hours from last treatment session).
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Secondary outcome [5]
375755
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Neck Disability Index questionnaire.
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Assessment method [5]
375755
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Timepoint [5]
375755
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.At baseline and after last treatment (within 24 hours from last treatment session).
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Secondary outcome [6]
375756
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Tampa Scale for Kinesiophobia.
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Assessment method [6]
375756
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Timepoint [6]
375756
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.At baseline and after last treatment (within 24 hours from last treatment session).
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Secondary outcome [7]
375757
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Pain Catastrophizing Scale.
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Assessment method [7]
375757
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Timepoint [7]
375757
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.At baseline and after last treatment (within 24 hours from last treatment session).
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Secondary outcome [8]
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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” .
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Assessment method [8]
375758
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Timepoint [8]
375758
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Baseline
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Secondary outcome [9]
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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”
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Assessment method [9]
375759
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Timepoint [9]
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After last treatment (within 24 hours from last treatment session).
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Secondary outcome [10]
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Area of pain: painful area drawn using a digital pain mapping device.
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Assessment method [10]
375760
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Timepoint [10]
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After last treatment (within 24 hours from last treatment session).
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Secondary outcome [11]
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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.
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Assessment method [11]
377410
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Timepoint [11]
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Baseline
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
People administering the treatment will be blind to the baseline measures e.g. central nervous system hyperexcitability status.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
3/03/2020
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Actual
3/03/2020
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Date of last participant enrolment
Anticipated
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Actual
25/02/2021
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Date of last data collection
Anticipated
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Actual
19/03/2021
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Sample size
Target
60
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Accrual to date
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Final
63
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Recruitment outside Australia
Country [1]
21916
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Spain
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State/province [1]
21916
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Bizkaia
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Funding & Sponsors
Funding source category [1]
303999
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University
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Name [1]
303999
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University of the Basque Country UPV/EHU
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Address [1]
303999
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Department of Physiolog, Faculty of Medicine and Nursing, University of the Basque Country, Barrio Sarriena, s/n Leioa, 48940, Spain
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Country [1]
303999
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Spain
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Primary sponsor type
University
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Name
University of the Basque Country UPV/EHU
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Address
Department of Physiolog, Faculty of Medicine and Nursing, University of the Basque Country, Barrio Sarriena, s/n Leioa, 48940, Spain
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Country
Spain
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Secondary sponsor category [1]
304172
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None
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Name [1]
304172
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Address [1]
304172
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Country [1]
304172
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304492
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University of the Basque Country Research Ethics Committee.
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Ethics committee address [1]
304492
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University of the Basque Country, Barrio Sarriena, s/n Leioa, 48940 Spain
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Ethics committee country [1]
304492
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Spain
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Date submitted for ethics approval [1]
304492
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Approval date [1]
304492
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03/06/2019
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Ethics approval number [1]
304492
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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
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Josu Zabala Mata
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Address
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Department of Physiolog, Faculty of Medicine and Nursing, University of the Basque Country, Barrio Sarriena, s/n Leioa, 48940, Spain
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Country
97138
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Spain
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Phone
97138
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+34606282577
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Fax
97138
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Email
97138
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[email protected]
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Contact person for public queries
Name
97139
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Mr Josu Zabala Mata
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Address
97139
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Department of Physiolog, Faculty of Medicine and Nursing, University of the Basque Country, Barrio Sarriena, s/n Leioa, 48940, Spain
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Country
97139
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Spain
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Phone
97139
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+34606282577
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Fax
97139
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Email
97139
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[email protected]
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Contact person for scientific queries
Name
97140
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Mr Josu Zabala Mata
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Address
97140
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Department of Physiolog, Faculty of Medicine and Nursing, University of the Basque Country, Barrio Sarriena, s/n Leioa, 48940, Spain
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Country
97140
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Spain
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Phone
97140
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+34 946017947
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Fax
97140
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Email
97140
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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