Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000430730
Ethics application status
Approved
Date submitted
12/04/2013
Date registered
16/04/2013
Date last updated
7/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mechanical Response of the Intervertebral Disc After Manipulation in Subjects with Degenerative Disc Disease
Scientific title
Improvement of the Mechanical Response of the Intervertebral Disc after Spinal Manipulation in Male Subjects with Degenerative Disc Disease: A randomized Controlled Trial
Secondary ID [1] 282328 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Self-perceived low back pain
 288872 0
Neural Tension (Sciatic nerve)
 288873 0
Spinal mobility in flexion
288874 0
Degenerative Disc Disease 288889 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289215 289215 0 0
Physiotherapy
Musculoskeletal 289216 289216 0 0
Other muscular and skeletal disorders
Neurological 289233 289233 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Spinal Manipulation (Pull-Move Technique) in the Treatment Group

The Spinal Manipulation technique (pull-move) will be performed according to previous literature.
The subject positions himself in a lateral decubitus position of the opposite side to the posteriority. The uppermost lower limb is flexed until mechanical impact and tension is caused in the fifth lumbar vertebra. The therapist stands facing the patient. The front leg is supported against the edge of the bed and the back leg is flexed with the tibia placed in the popliteal fossa. With the upper hand, the therapist controlls the subject's trunk. The forearm of the caudal hand makes contact with the sacroiliac joint, placing the index finger in the L5 spinous process. Three stages will follow from here: (a) placing the levers. After contacting with L5 from increased flexion of the hip, the therapist keeps the spine in a neutral position. Then, the therapist extends the patient's upper limb against the bed to carry out the rotation of the spine to L5 level; (b) reducing the slack. The therapist´s caudal hand directs L5 towards the ceiling, making contact with its spinous process and (c) thrust. The caudal hand pushes the pelvis in the ventral direction and directs the spinous process to revert the L5. The cephalic hand counter thrusted. The thrust should be short range and very fast.
The protocol will last for two minutes approximately.
Participants in this group will only receive a single spinal manipulation
Intervention code [1] 286943 0
Rehabilitation
Intervention code [2] 286958 0
Treatment: Other
Comparator / control treatment
In the control group the intervention manoeuver consists in maintaining the same therapist-patient position as previously described for the treatment group. However, after entering the parameters, no tension will be added as no levers, slack reduction nor articular thrust will be performed. The position will be maintained during the same length of time as estimated for the pull-move technique.
Control group
Placebo

Outcomes
Primary outcome [1] 289325 0
Improvement of Self-Perceived low back pain in at least 20%

Low back pain is measured with a visual analogue scale (VAS). The VAS consists of a horizontal 100 mm line where the subject marks their perceived pain severity. The range is from 0 mm (no pain) to 100 mm (severe pain).The VAS is an effective, sensitive and appropriate tool to measure acute and chronic pain
Timepoint [1] 289325 0
3 minutes after intervention
Primary outcome [2] 289326 0
Improvement of Neural Tension by means of passive straight leg raise test in at least 15%

Nerve root tension will be observed by means of the passive straight leg raise (SLR) test. The initial appearance of pain or discomfort will be the test end point. In this position a goniometer (model Carci) will be used to measure the range of coxofemoral flexion. The fixed arm will be placed on the mid axillary trunk line, while the mobile arm will be placed on the lateral surface of the hip resting on the greater trochanter and aligned with the shaft of the femur. The lower limb that presents radiating pain will be chosen to be assessed. The SLR test is considered an easy tool to use, with hip flexion reliability (ICC) of 0.87 (95% CI: 0.69 - 0.95).
Timepoint [2] 289326 0
4 minutes After Intervention
Primary outcome [3] 289327 0
INCREASE OF SUBJECT'S HEIGHT IN AT LEAST 20%

Subject's height is measured by means of a stadiometer. The stadiometer is a device which measures height variations and the amount of Intervertebral disc compression, susceptible to reflect the spinal load. The first step of the protocol is to familiarise and train the individuals in the procedure so as to minimise measurement errors. The participants are considered sufficiently trained when after five consecutive evaluations, the measurements showed a standard deviation of less than 0.5 mm. The person's height is measured after a short time (90 seconds) standing upright. This waiting time is established to allow any deformed body structures to reach their equilibrium. To prevent postural adjustments while measuring, fixing metal bars are placed on different anatomical points; occipital protuberance, cervical level, lower limit of the shoulder blades, and the second sacral vertebrae. To stop head movement and keep it aligned, the subject wears safety glasses with a leveling system. Finally, after adjusting the position, the measuring stick of the digital transducer is positioned on the center of gravity above the subject's head. The subject remains on the stadiometer at all times during successive measurements, instead of using the in-out method. The stadiometer is a noninvasive method that has proved validity.
Timepoint [3] 289327 0
6 minutes after intervention
Secondary outcome [1] 302248 0
INCREASE OF SPINAL MOBILITY IN FLEXION IN AT LEAST 10%
Subjects will be assessed using the finger to floor distance (FFD) test. The FFD test evaluates the maximum spinal mobility in flexion and it is a possible indicator of functional limitation. The test will be conducted according to the methodology already established in the literature. The subject stands barefoot, with legs slightly apart, knees straight and back straight. From this position the subject is asked to bend forward as far as possible without feeling pain or discomfort. The distance between the third fingertip and the floor is measured with a tape measure. The subjects maintain this maximum flexion position for two seconds before measurements are taken. This test is considered as easy to conduct and with a high degree of interexaminer reliability (r 0.96 to 0.98)
Timepoint [1] 302248 0
5 minutes after intervention

Eligibility
Key inclusion criteria
(a) males between 18-55 years of age; (b) standardised body mass index (between 20-25 kg/m2), (c) clinical diagnosis of lumbosacral degenerative disc disease.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion factors for participation in the clinical trial are: (a) smokers; (b) history of alcoholism or alcohol consumption within 24 hours prior to data collection; (c) elite sports-people; (d) a diagnosis of median, fragmented or migrating herniation; (e) cauda equina syndrome; (f) general contraindications to spinal manipulatio, eg tumour diseases and ankylosing spondylitis, among others;19 (g) previous degenerative disc surgery; and (h) spinal manipulation treatment within three months prior to the study.

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 participants will be recruited from a private clinical consultancy. Treatment allocation will be by means of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence was obtained using free software (randomization.com) and an outside collaborator to the study safeguarded it from all those participating in the research: study subjects, evaluators and the therapist responsible for the intervention in both groups
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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
The descriptive and inferential analysis of the results will be performed using the BioEstat 5 free software programme. The mean, standard deviation and 95% confidence interval (95% CI) will be calculated for the different variables. The significance level will considered for a value of p<.05.
The D'Agostino test will verify the normality of the study variables. The comparison between groups will use the student t statistic for the initial values of the quantitative variables, and the Chi-square (X2) for the categorical variables. In the intra-group comparison, the Student t-test will be used to analyse the parametric dependent variables while the Mann-Whitney U test will be used for the nonparametric variable.
The analysis of variance for repeated measures (ANOVA test) with the group (control or experimental) will allow the intergroup differences to be observed. In the same way, the correlation test (Pearson or Spearman) will be used to verify the association between extraneous variables and the dependent variables.

The sample size has been calculated using the Granmo version 7.12 software (IMIM Hospital del Mar, Barcelona, Spain). For a two-sided contrast and accepting an alpha value of .05 and a beta risk of .01, eighteen subjects are required per study group to detect a difference that is equal to or greater than 17.5% in the mean intergroup value of the stadiometry, based on the observations made previously. 15% standard deviation is assumed together with an estimated 10% loss to follow-up rate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/03/2012
Actual
26/03/2012
Date of last participant enrolment
Anticipated
26/09/2012
Actual
31/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5012 0
Brazil
State/province [1] 5012 0
Curitiba ,Parana

Funding & Sponsors
Funding source category [1] 287084 0
University
Name [1] 287084 0
Faculdade Dom Bosco, Curitiba (Curitiba, Brazil)
Country [1] 287084 0
Brazil
Primary sponsor type
University
Name
Faculdade Dom Bosco, Curitiba (Curitiba, Brazil)
Address
Rua Manoel Ribas, 2181
80810-000
Merces, Curitiba, Parana
Country
Brazil
Secondary sponsor category [1] 285859 0
None
Name [1] 285859 0
Address [1] 285859 0
Country [1] 285859 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289101 0
Research and Ethics Committee of the Dom Bosco Faculty, Curitiba, Parana, Brazil
Ethics committee address [1] 289101 0
Rua Paulo Martins, 332
80710-010
Merces, Curitiba, Parana
Ethics committee country [1] 289101 0
Brazil
Date submitted for ethics approval [1] 289101 0
28/02/2011
Approval date [1] 289101 0
15/03/2011
Ethics approval number [1] 289101 0

Summary
Brief summary
We hypothesized that in male patients with lumbosacral degenerative disease, a high velocity low amplitude spinal manipulation in the lumbosacral segment (pull-move technique), will produce an immediate change in functional capacity and on the mechanical behavior of the lumbar spine, affecting the subject's height .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39246 0
Dr FELIPE VIEIRA-PELLENZ
Address 39246 0
Felipe Vieira-Pellenz
Department of Physical Therapy. Faculty Dom Bosco, Curitiba, Parana, Brazil.
Avenida Manoel Ribas, 2181
80810-000
Merces, Curitiba, Parana
Country 39246 0
Brazil
Phone 39246 0
+55 41 3218-5550
Fax 39246 0
Email 39246 0
felipepellenz@gmail.com
Contact person for public queries
Name 39247 0
Dr ANGEL OLIVA-PASCUAL-VACA
Address 39247 0
Dr. Angel Oliva-Pascual-Vaca.
Head of Physical Therapy Department. Faculty of Nursing, Physiotherapy and Podiatry. University of Sevilla, Sevilla, Spain
c/ AVICENA s/n 41009 SEVILLA
Country 39247 0
Spain
Phone 39247 0
+34 954 48 65 28
Fax 39247 0
+34 954 48 65 27
Email 39247 0
angeloliva@us.es
Contact person for scientific queries
Name 39248 0
Dr ANGEL OLIVA-PASCUAL-VACA
Address 39248 0
Dr. Angel Oliva-Pascual-Vaca.
Head of Physical Therapy Department. Faculty of Nursing, Physiotherapy and Podiatry. University of Sevilla, Sevilla, Spain
c/ AVICENA s/n 41009 SEVILLA
Country 39248 0
Spain
Phone 39248 0
+34 954 48 65 28
Fax 39248 0
+34 954 48 65 27
Email 39248 0
angeloliva@us.es

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