The addition of upper cervical manipulative therapy in the treatment of patients with fibromyalgia: A randomized controlled trial

INTERVENTION: 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. Upper cervical manipulative therapy CONDITION: fibromyalgia ; SECONDARY OUTCOME: Algometric score ; Algometric score (kg/cm2) was calculated as the average of the minimum pain‐generating pressure values obtained from 18 points. ; Beck Anxiety Inventory. ; measures anxiety severity while discriminating anxiety from depression. It contains 21 items with a total score of 0–63, where higher scores indicate more anxiety. 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. 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 PRIMARY OUTCOME: The primary outcome measure for determining the treatment effect was Fibromyalgia Impact Questionnaire, which is a valid self‐administered questionnaire developed to measure fibromyalgia participant status, progress, and outcomes. The Fibromyalgia Impact Questionnaire is composed of 10 subscales of disabilities and symptoms (physical function, work missed day, job ability, feel good, pain, fatigue, sleep, stiffness, anxiety and depression).The total scores range from 0 to 100, higher the Fibromyalgia Impact Questionnaire score, the greater is the impact of fibromyalgia on the participant ; Beck Depression Inventory. ; Is a questionnaire developed and validated for patients with depression. It contains 21 items that assess the cognitive, affective, and neurovegetative factors associated with depression. The range of score is 0–63, where values above 13 indicate presence of depression, and values above 21 indicate major depression ; Rasterstereographic posture analysis ; Rasterstereography (Formetric 2, Diers International GmbH, Schlangenbad, Germany) was used to examine posture and back shape characters. All testing procedures were done following Lippold et al’s protocol.The Formetric scans were taken in a relaxed standing position. The patient was positioned in front of the black background screen at a distance of two meters from the measurement system. The column height was aligned to move the relevant parts of the patient's back into the center of the control monitor by using the column up/down button of the control unit; to ensure the best lateral and longitudinal position of the patient a permanent mark on the floor was used. The patient's back surface (including upper buttocks) was completely bare in order to avoid image disturbing structures. ; ; After the patient and the system were correctly positioned, the system was ready for image recording. The image processing consists of automatic back surface reconstruction and shape analysis. The sagittale plane parameters (lumbar angles, thoracic angles, and trunk inclination), the frontal plane parameters (trunk imbalance and lateral deviation) and the transversal plane parameters (vertebral surface rotation and pelvis torsion) were selected to cover the posture profile in three planes. Sleep quality ; The Pittsburgh Sleep Quality Index will be used to assess sleep quality and disturbances over a 1‐month time interval. Nineteen individual items generate seven “component” scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. ; The Pain Catastrophizing Scale ; is used to assess three factors: rumination, magnification and helplessness associated to pain. It includes 13 items measured on a 5‐point Likert scale ranging from 0 (not at all) to 4 (all the time). Higher scores indicate a greater tendency to catastrophize pain symptoms. ; 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 deg