Out of the 376 patients in the accessible population, 351 were subjected to a randomization procedure to recruit a sample of 119 patients. Out of these 119 patients, 15 were excluded, and the remaining 104 were randomly assigned by means of a balanced stratified assignment to an inter- vention (n ¼ 52) or placebo (n ¼ 52) group. The groups were balanced for type of medication received, sex and age, using a stratification system that generates a sequence of letters (from a table of correlatively ordered permutations) for each category and combination of cate- gories. Informed consent was obtained from all partici- pants according to the ethical criteria established in the Helsinki declaration, modified in 2000, for the perfor- mance of research projects. In Spain, current legislation for clinical trials is gathered in the Real Decreto 223/2004 February 6, 2004. This project was approved by the research commissions of the University of Almeria and of the Torrecardenas Hospital Complex (Almeria)- Servicio Andaluz de Salud (Andalusian Healthcare Service).
Twenty-one patients were under treatment with muscle relaxants, 32 with antidepressants, 46 with anxiolytics, 59 with anti-inflammatories, 36 with corticoids and 84 with analgesics.
The following instruments were used to measure anxiety, depression and quality of life in study participants:
Visual analogue scale (VAS) for pain (29): This scale assesses the intensity of pain and degree of alleviation experienced by the patient (0 ¼ no pain, 10 ¼ unbearable pain) (30).
Short form-36 health survey (SF-36) for quality of life: The SF-36 survey evaluates dimensions of functional state, emotional wellbeing and health. Functional state dimensions are: physical function (10 items), social function (two items), role limita- tions due to physical problems (four items) and role limitations due to emotional problems (three items); emotional wellbeing dimensions are: mental health (five items), vitality (four items) and pain (two items); and health dimensions are: general health perception (five items) and change in health over time (one item—not included in final score) (31).
Pittsburgh Sleep Quality Index (PSQI): This ques- tionnaire comprises 24 questions, 19 for subjects and 5 for individuals living with them. It yields scores for: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of hypnotic medication and daily dysfunction. Each component is scored on a scale of 0 to 3 (0 ¼ no problem, 3 ¼ severe prob- lem), yielding an overall score range of 0–21 (32).
3 of 9
Assessment of the depression index (Beck depres- sion inventory): The Beck inventory is a self- applied questionnaire of 21 items that assesses a broad spectrum of depressive symptoms. It gives weight to the cognitive component of depression, with symptoms in this area representing around 50% of the total questionnaire score. Out of the 21 items, 15 refer to ecological-cognitive symp- toms, and six to somatic-vegetative symptoms
. The score for each item ranges from 0–3 (from least to greatest severity), giving an overall score range of 0–63 points (34).
State Trait Anxiety Inventory (STAI): This 40-item questionnaire measures trait anxiety and state anxiety. For the trait anxiety scale (20 items), subjects describe how they feel in general, and for the state anxiety scale (20 items), how they feel at the present time. A score is obtained for each scale (35).
In this experimental, longitudinal double-blind clinical trial, the intervention group was formed by 43 patients and the placebo group by 41. Before the treatments, initial assessments of anxiety, depression, pain, sleep and quality of life were performed in all patients (36). Women of childbearing age were assessed the day after their menstrual period ended. These assessments were repeated at 30 min, six months and 1 year after the last session of the 25-week treatment program.
The intervention group underwent a craniosacral therapy protocol, with two weekly sessions of 1 h for 25 weeks. The treatment was carried out by an expert craniosacral therapist with the patient in prone position. This therapy consists of applying very mild manual traction on cranial bones in flexion or extension stages of the craniosacral cycle. The aims were to contribute to re-establishing the normal movement of cranial bones and to intervene in the autonomic nervous system by releasing bone and membranous restrictions (37). Craniosacral therapy procedures were: still point (occipital), compression– decompression of temporomandibular joint, decompres- sion of temporal fascia, compression–decompression of sphenobasilar joint, parietal lift, frontal lift, scapular waist release and pelvic diaphragm release (37–40).
The placebo group underwent two weekly 30-min sessions of sham ultrasound treatment in which the dis- connected probe (4 cm in diameter) was applied to the cervical area (10 min), lumbar region (10 min) and both sides of the knees (10 min). The sham treatment was per- formed with the patient in prone position. The screen of
Downloaded from http://ecam.oxfordjournals.org at Goteborg University on September 8, 2010