None listed
Conditions
Brief summary
The purpose of this study was to investigate the immediate and long-term effects of a 12 weeks multimodal programme, with the addition of upper cervical manipulative therapy, on fibromyalgia management outcomes in addition to three-dimensional postural measures. In this study a total of 120 (52 female) patients with fibromyalgia syndrome and definite C1-2 joint dysfunction were randomly assigned to the control or an experimental group. Both groups received a multi-modal programme; additionally, the experimental group received upper cervical manipulative therapy. Primary outcomes were the Fibromyalgia Impact Questionnaire, whereas secondary outcomes included Pain Catastrophizing Scale, algometric score, Pittsburgh Sleep Quality Index, Beck Anxiety Inventory, Beck Depression Inventory, and three-dimensional postural measures. In this study we hypothesized that the addition of the upper cervical manipulative therapy to a multimodal programme is beneficial in treating patients with fibromyalgia syndrome.
Interventions
The patients in study group completed a 12 week multimodal programme consisting of education programme, cognitive behavior therapy, and exercise programme. Education programme It consisted of twelve 2 hour sessions delivered over the treatment period (1 session per week). This education part of the programme included information about typical symptoms, usual course, medical conditions, potential causes of the illness, the influence of psychosocial factors on pain, current pharmacologic and non-pharmacologic treatments, the benefits of regular exercise, and the typical barriers to behavior change. The patients were encouraged to be active, to ask questions and to discuss issues with the speakers or with other participants. It was important that they shared their daily experience of the syndrome because it helps to illustrate the theoretical concepts addressed in the sessions. The education programme is group based (small groups of four to five participants) led by Senior Physiotherapist. Cognitive behavior therapy The Multi method CBT (12 weekly 2 hour sessions) typically consisted of a combination of various components included educational, physical, cognitive, and behavior elements. Educational component: included education about the rationale for behavioral pain management as well as, distraction, activity pacing, problem solving to enable the patients to analyze and develop plans for dealing with pain flares and other challenging situations. The physical component: involved the management of physical symptoms using a combination of relaxation techniques. These include diaphragmatic breathing, progressive relaxation and guided visualization. Cognitive restructuring component: included challenging counterproductive beliefs such as unrealistic expectations regarding recovery time frames and emphasizing the relative benefits of active exercise and self-management as opposed to passive treatment. Behavior modification component: included positive reinforcement of wellness behaviors such as increasing exercise intensity and reduction of analgesic medication use at a gradual rate over the course of the treatment. Certain social behaviors such as returning to social activity and performing domestic tasks also were positively reinforced. Group-based treatment program of CBT administered to small groups of four to five participants. The group sessions were administered by three trainee psychologists with experience in CBT. Each therapist was provided with a treatment manual to ensure participants in each group received identical information.. For all therapists, a clinical psychologist specialized and highly experienced in treating FMS was consulted weekly to discuss clinical issues, ensure proper provision of treatment, and maintain fidelity of treatment Exercise programme The programme conducted for 1 hour 3 times a week for 12 weeks. This exercise programme consisted of relaxation techniques based on the published regimen by Ost dynamic (slow, controlled leg and arm swings), active stretching (ie, bringing the leg up high and holding it there without anything to keep it in that extended position), and passive stretching (ie, reaching out to the feet while sitting up).The exercise programme is group based (small groups of four to five participants) led by Senior Physiotherapist. Participants were instructed to perform relaxation exercises at home, twice daily for about 20 minutes ,as their home routine. To monitor accurately the exercise times and the number of sets performed during the study, a pamphlet illustrating the exercises and a record sheet were distributed to the participants, who were instructed to record the time and sets of the exercises performed at home. The record sheets were collected every week and analyzed to calculate the mean exercise frequency per week and the mean exercise time per day. Also the administration of 2 minute massage with no therapeutic effect prior to the treatment was used. Upper cervical manipulative therapy In addition to the multimodal in facility and at home programmes, the participants in the experimental group also received the upper cervical manipulative therapy. Prior to each treatment session, the vertebral artery test was performed bilaterally, followed by a 2 minute gentle neck massage, without lubricants and with no proven therapeutic effect. the 2 minute massage session performed by well trained physiotherapist and started by gentle stroking on the neck and shoulder , followed by fixed circular motion starting form profundus (the hollow just behind the ear)to the terminus,repeated from 5 to seven times The manipulative therapy intervention followed the regimen described by Maitland et al. This regimen includes the use of both low velocity cervical joint mobilization techniques (in which the cervical segment is moved passively with rhythmical movements) and high velocity manipulation techniques in the treatment of cervical joint disorders. The manipulative therapy intervention followed normal clinical practice, in which the choice of initial and subsequent manipulative therapy techniques is at the treating therapist’s discretion, based on the initial and progressive assessment of the patient’s cervical joint dysfunction. Thus, patients could receive a combination of low- and high velocity techniques as indicated in best clinical practice with the Maitland regimen.the manipulation procedures were performed by two physiotherapists well trained, experienced and licensed to perform manipulation Nonthrust mobilization With the patient in the prone position, the therapist performed one 30 second bout of left sided unilateral posterior-anterior mobilizations to the C1-2 motion segment, as described by Maitland. This same procedure was repeated for one 30 second bout to the right atlantoaxial joint. A high-velocity low-amplitude thrust manipulation With the patient in the supine position, the therapist contacted the left posterior arch of the atlas. with the lateral aspect of the proximal phalanx of the left second finger using a “cradle hold.” To localize the forces to the left C1-2 articulation, secondary levers of extension, posterior-anterior shift, ipsilateral side bend, and contralateral side shift were used. While maintaining the secondary levers, the therapist performed a single A high velocity low amplitude thrust manipulation to the left atlanto axial joint, using the combined thrusting primary levers of right rotation in an arc toward the under side eye and translation toward the table. This was repeated using the same procedure but directed to the right C1-2 articulation. We did ask participants to refrain from starting any new regular physical activity or exercise programmes (that were unrelated to the study) or other non-pharmacological interventions for fibromyalgia during their 1 year involvement. Upper cervical manipulative therapy was conducted for 12 treatments (three times weekly ) over a 1 month period, along with “maintenance spinal manipulation” one session per week for the following 8 weeks. This manipulative sessions lasting 15 to 20 minutes during which a physiotherapist examined and localize the C1-C2 , then performed spinal manipulation. all components of the intervention(education programme, cognitive behavior therapy, exercise programme, and cervical manipulation) were complete within the specified 12 week period
Sponsors
Study design
Eligibility
Inclusion criteria
Patients were enrolled, if they fulfilled the American College of Rheumatology criteria for fibromyalgia syndrome, experienced symptoms for at least 48 months with no recent remission of symptoms to any degree, reported a score >4 on the pain intensity, age 40–65 years, reported a score greater than or equal to 59 on the Fibromyalgia Impact Questionnaire “severe fibromyalgia” , and able to read and comprehend English. Further , the patients were included if they had a limited C1-C2 ROM using the flexion-rotation test.The flexion-rotation test has been found to possess high diagnostic validity for determining the presence of C1-2 joint dysfunction, Ogince et al reporting sensitivity and specificity of 91% and 90%, respectively. For asymptomatic subjects, mean unilateral ROM during the flexion rotation test, to the left or right, has been found to be 39 degree to 45 degree; whereas subjects with C1-2 joint dysfunction have been found to possess only 22 degree to 26 degree of unilateral ROM towards the most restricted side during the flexion rotation test.
Exclusion criteria
Exclusion criteria included rheumatoid disease, unstable hypertension, severe cardiopulmonary problems, chronic viral infection, and history of any significant medical conditions such as hepatitis, herpes, lupus, multiple sclerosis, rheumatoid arthritis, polio, epilepsy, rheumatic fever, cancer, history of neck or back surgeries, or any psychiatric disorder affecting participant compliance.