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Trial registered on ANZCTR


Registration number
ACTRN12615000412538
Ethics application status
Approved
Date submitted
3/03/2015
Date registered
1/05/2015
Date last updated
1/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cervical spinal manipulation versus thoracic spinal manipulation on peripheral neural features and grip strength in subjects with chronic mechanical neck pain: A randomized controlled trial.
Scientific title
To compare the immediate effects of cervical and thoracic spinal manipulative therapy (SMT) on neural mechanosensitivity of upper limb nerve trunks and grip strength in patients with chronic neck pain (NP).
Secondary ID [1] 286307 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mechanical neck pain 294406 0
neural mechanosensitivity 294762 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294710 294710 0 0
Physiotherapy
Neurological 295169 295169 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The sample included subjects with mechanical non-specific NP, that were randomly distributed into three groups. The cervical group received a high-velocity low amplitude (HVLA) spinal manipulation over the lower cervical spine (C7), the thoracic group underwent a HVLA spinal manipulation over the upper thoracic spine (T3), whereas the placebo group (PG) received a sham-manual contact. Measurements were taken before intervention and immediately afterwards of the pressure pain threshold over the median, ulnar and radial nerves and free-pain grip strength with a hydraulic dynamometer.The intervention performed a physiotherapist and lasted five minutes in a single session.
Intervention code [1] 291350 0
Rehabilitation
Intervention code [2] 291626 0
Treatment: Other
Comparator / control treatment
The placebo manouvre consisted in the therapist placing her hands on the patient's head. The aim was to provide a manual stimulus and the therapist presence. The intervention time for the placebo technique is five minutes and it will be performed only once.
Control group
Placebo

Outcomes
Primary outcome [1] 294474 0
Pressure Pain Threshold (PPT) over the upper limb nerve trunks
The PPT, as the primary outcome measure, was assessed with a digital dynamometer with compression force between 5-20 kg, (PCE Instruments UK Ltd, Southampton), model FM200, and with a contact probe size of 1 kg / cm squared. Measurements were made alternatively on both upper limbs, starting with the right side. A increasing pressure of 1kg/cm squared was used, with a resting period of 30 seconds between measurements. The reference PPT score was the mean of three measurements in each spot. Subjects were instructed to tell the evaluator to stop when the sensation changed from pressure to slightly unpleasant pain. PPT was evaluated over the upper limb nerve trunks, with the subject lying supine, and in the following order: (a) median nerve, which was located in two diffferent sites. First, the nerve was located at the carpal tunnel site, lateral to the flexor carpi radials muscle. Second, the nerve was also marked in the ulnar fossa, medial to and immediately adjacent to the tendon of biceps brachii; (b) the ulnar nerve was palpated in the space between the medial epicondyle and the olecranon, once the elbow was previously flexed; and (c) the radial nerve, which was located in the humeral tunnel torsion, between the medial and lateral heads of the triceps brachii at the mid third of the humerus. Pressure algometry is a valid tool that has shown a high inter-examiner reliability, ICC = 0.91 (95% CI 0.82-0.97). The standard error of measurement (SEM) in healthy individuals ranges from 0.52kg / cm squared 0.64 kg / cm squared
Timepoint [1] 294474 0
Immediately after the intervention
Secondary outcome [1] 313405 0
Grip Strength (GS)
The pain-free grip strength (GS) was evaluated with an isometric, hydraulic hand dynamometer (JAMAR registered trademark, mod 5030J1, Illinois, USA). Dynamometry is a reliable, reproducible and easy-to-use tool. Following the guidelines of the American Society of Hand Therapists, the subject was standing, with the shoulder adducted and neutrally rotated, arm and elbow along the body, elbow flexed to 90 degrees, forearm in the neutral position, and the wrist with a ‘subtle’ dorsal flexion and ulnar deviation, if needed, or in the neutral position. This procedure has shown an excellent test-retest reliability, with ICC values ranging between 0.81 and 0.98. The subject was instructed to “squeeze the handle as strong as possible” without feeling pain or discomfort. Three measurements of 5 seconds each and with a 15-second resting period between them, to prevent fatigue, were carried out, taking the mean as the reference value.
Timepoint [1] 313405 0
Immediately after the intervention

Eligibility
Key inclusion criteria
(a) age between 20 and 50 years old; (b) NP (grades I or II) of at least 12 weeks of duration; and (c) a positive response to the ULNT of the median nerve (ULNT-1) in at least one upper limb.
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects who had one or more of the following conditions were excluded: (a) any contraindication to SMT (bone pathology, tumors, inflammatory disease...); (b) current use of any drugs or medication; (c) mechanical NP secondary to whiplash, congenital or acquired torticollis, rheumatoid arthritis, advanced cervical osteoarthritis and / or cervical myelopathy; (d) previous history of joint disease, tendinitis, severe trauma or surgery in the upper extremity and / or cervical spine; (e) cervicobrachial radiculalgia associated with herniation or disc protrusion at lower cervical spine; (f) diagnosis of carpal tunnel syndrome or previous surgery at this level; (g) serious hormonal imbalance, history of diabetes and / or hypothyroidism; (h) having received SMT in the eight weeks before data collection; (i) pregnant or menopausal women.

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 allocation was concealed by central randomization by computer.The central randomization by random sequence was obtained using the free software Epidat 3.1. Ministry of Health of the Government of Galicia, Spain and Pan American Health Organization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using the free software Epidat 3.1.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The statistical processing of the data was conducted using the statistical package PASW Advanced Statistics 18.0 (SPSS Inc., Chicago, USA). Findings are expressed as the mean with the corresponding standard deviation and/or 95% confidence intervals (95% CI), or as percentage frequencies. Normality of the study variables was assessed using the Shapiro-Wilk test. The comparison between-groups for baseline data was made with the analysis of variance (ANOVA) for quantitative variables with normal distribution, the Kruskall-Wallis test for quantitative data with no normal distribution, and the chi-squared test for qualitative variables. To compare the effectiveness of the interventions on pressure algometry over upper limb nerve trunks and free-pain GS a separate 2-by-3 mixed-model ANOVA, with time (pre intervention or postintervention) as within-subjects variable and group as between-subject variable. Effect sizes were calculated using the Cohen d coefficient. The Bonferroni test was used for post hoc analysis. All the analysis were conducted considering statistically significant a p-value < 0.05. The sample size is performed through a pilot study (n=20) and statistical analysis, and calculation of effect size considering statistically significant a p<0.05 and power 80%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/04/2015
Actual
21/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment outside Australia
Country [1] 6715 0
Spain
State/province [1] 6715 0
Valencia

Funding & Sponsors
Funding source category [1] 290877 0
University
Name [1] 290877 0
University of Seville (Spain)
Country [1] 290877 0
Spain
Primary sponsor type
University
Name
University of Seville (Spain)
Address
Department of Physiotherapy.
Faculty of Nursing, Physiotherapy and Podiatry.
Avicena street, 41009 Seville (Spain)
Country
Spain
Secondary sponsor category [1] 289562 0
None
Name [1] 289562 0
Address [1] 289562 0
Country [1] 289562 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 55510 0
Dr Francisco Bautista Aguirre
Address 55510 0
Clinica Paco Bautista
Dos de mayo 6, Avenue.
46960 Aldaia (Valencia)
Country 55510 0
Spain
Phone 55510 0
+34-961578060
Fax 55510 0
Email 55510 0
francisco.bautista@uem.es
Contact person for public queries
Name 55511 0
Francisco Bautista Aguirre
Address 55511 0
Clinica Paco Bautista
Dos de mayo 6, Avenue.
46960 Aldaia (Valencia)
Country 55511 0
Spain
Phone 55511 0
+34-961578060
Fax 55511 0
Email 55511 0
francisco.bautista@uem.es
Contact person for scientific queries
Name 55512 0
Angel Oliva Pascual-Vaca
Address 55512 0
Department of Physiotherapy.
Faculty of Nursing, Physiotherapy and Podiatry.
Avicena Street, 41009 Seville (Spain)
Country 55512 0
Spain
Phone 55512 0
+34-954486502
Fax 55512 0
+34-954486527
Email 55512 0
angeloliva@us.es

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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