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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000006549
• Date of registration: 07/01/2015
• Prospective Registration: No
• Primary sponsor: Ibrahim Moustafa Moustafa
• Public title: The addition of upper cervical manipulative therapy in the treatment of patients with fibromyalgia: A randomized controlled trial
• Scientific title: The addition of upper cervical manipulative therapy to multimodal programme on Fibromyalgia Impact Questionnaire, Pain Catastrophizing Scale, algometric score, Pittsburgh Sleep Quality Index, Beck Anxiety Inventory, Beck Depression Inventory, and 3D postural measures in patients with fibromyalgia
• Date of first enrolment: 07/08/2012
• Target sample size: 120
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000006549.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);

Countries of recruitment

Egypt

Contacts

• Name: A/Prof Ibrahim Moustafa Moustafa

• Name: A/Prof Ibrahim Moustafa Moustafa

Key inclusion & exclusion criteria

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.

Age minimum: 40 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neurological - Other neurological disorders

Physical Medicine / Rehabilitation - Physiotherapy

fibromyalgia;
fibromyalgia

Musculoskeletal - Other muscular and skeletal disorders

Intervention(s)

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 unrea

Primary Outcome(s)

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
[three time intervals: baseline, 12 weeks, and 1 year after the 12 week follow up.]

Secondary Outcome(s)

Algometric score
Algometric score (kg/cm2) was calculated as the average of the minimum pain-generating pressure values obtained from 18 points.
[three time intervals: baseline, 12 weeks, and 1 year after the 12 week follow up.]

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.
[three time intervals: baseline, 12 weeks, and 1 year after the 12 week follow up.]

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.
[three time intervals: baseline, 12 weeks, and 1 year after the 12 week follow up.]

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.
[three time intervals: baseline, 12 weeks, and 1 year after the 12 week follow up.]

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
[three time intervals: baseline, 12 weeks, and 1 year after the 12 week follow up.]

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.[three time intervals: baseline, 12 weeks, and 1 year after the 12 week follow up.]

Secondary ID(s)

nil

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of the Faculty of Physical Therapy, Cairo Univercity