To determine the mid- and long-term efficiency (15, 30 and 120 days after starting sessions) of the SAT technique in patients with grade II acute WL, comparing it with a conventional rehabilitation program.
A prospective, single-blind, parallel group, randomized, will be carried out in the physiotherapy service of the Clinic Hospital of Terrassa with the participation of the rehabilitation, radiology, traumatology and surgery services. Patients will be recruited from emergency services of the Clinic Hospital of Terrassa and randomly divided into two groups MAN-Group and RHB-Group, using the random number generator of a statistical program (SPSS), to receive 3 and 20 treatment sessions, respectively. The treatment protocol was carried out during four weeks, and both interventions occurred over the same time period. In both treatment groups, patients started sessions during the first two week after the traffic car collision. MAN-Group were treated with cervical spine manipulation with SAT, after specialized physical therapists assessed there was no risk of vertebro-basilar injuries following the International Framework. Patients received a total of 3 sessions of treatment over a month (days 1, 15 and 30 after the beginning of the study). The RHB-group were treated with passive manual therapy (P-MT) by soft tissue mobilization, massage and muscular stretching of the anterior and posterior cervical muscles; active therapeutic exercises (A-TE); and oculo-cervical exercises (OC-E). Patients received a total of 20 sessions of 30 minutes each during 4 weeks. The exercises were performed five times (30 seconds interval each time) in a sitting position.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
129
The RHB-group were treated with passive manual therapy (P-MT) by soft tissue mobilization, massage and muscular stretching of the anterior and posterior cervical muscles; active therapeutic exercises (A-TE); and oculo-cervical exercises (OC-E). Patients received a total of 20 sessions of 30 minutes each during 4 weeks
Consorci Sanitari de Terrassa.
Terrassa, Barcelona, Spain
Subjective pain intensity
Neck pain intensity was assessed with a Visual Analogue Scale (VAS) to measure the amount of pain experienced by a subject from both groups on a continuum from 0 to 100 mm. Scores can range from 0 (no pain) to 100 (worst imaginable pain)19,20. This method has been proven to be a reliable, generalizable and internally consistent measure of clinical and experimental neck pain
Time frame: At baseline and at week 2, 4 and follow-up.
Neck specific disability
Neck-specific disability was measured with Neck Disability Index (NDI). The NDI is a valid measurement of disability in neck pain disorders. It is widely used and it has shown good reliability and validity in WAD studies. NDI scores can range from 0% (no limitation on activity) to 100% (worst possible disability).
Time frame: At baseline and at week 2, 4 and follow-up.
Cervical range of motion (CROM)
Neck range of motion was tested with the CROM Instrument. All cervical motions and subsequent measurements were performed according to the manufacturer's specifications and were reproduced exactly for each trial with a single examiner performing all measurements. CROM were assessed in a relaxed sitting position, hips and knees positioned at 90º angles and buttocks positioned against the back of the chair. The goniometer was placed on the top of the head and was set in the neutral position.
Time frame: At baseline and at week 2 and week 4.
Cervical lordosis Cobb angle
Cobb angle (COBB) method was measured to assess cervical lordosis (Cobb C2-C7) as the angle between the horizontal line on the lower endplate of C2 and a horizontal line on the lower endplate of C7. A clinically normal cervical lordosis has been described as a Cobb angle of 31-40 degrees, with subjects in standing and eyes focused straight ahead. A cervical lordosis of less than 20◦ from C2 to C7 has been shown to be related to cervical dysfunction and pain.
Time frame: At baseline and at week 4.
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Hospital anxiety and depression scale
HADS was used to determine the levels of anxiety and depression experienced by participants. HADS has 14 items and it was designed for the evaluation of anxiety and depression in non-psychiatric outpatient hospital services. The entire sum for both HADS anxiety and HADS depression levels ranges from 0 to 21. A score equal to or more than 10 indicates clinically significant symptoms of anxiety or depression.
Time frame: At baseline and at week 4 and follow-up.