Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000006549
Ethics application status
Approved
Date submitted
19/11/2014
Date registered
7/01/2015
Date last updated
7/01/2015
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 285681 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fibromyalgia 293536 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293806 293806 0 0
Physiotherapy
Musculoskeletal 293807 293807 0 0
Other muscular and skeletal disorders
Neurological 293982 293982 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 290622 0
Treatment: Other
Intervention code [2] 290755 0
Behaviour
Intervention code [3] 290756 0
Lifestyle
Comparator / control treatment
The patients in control 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. 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 control group received this multimodal programme in addition a manual contact intervention similar to the upper cervical thrust and non-thrust mobilization. Participants were informed that they were to be treated with an osteopathic functional technique which involved subtle positioning of the upper neck, which was held for 30 s, but no ‘position of ease’ or barrier was engaged, in order to keep the technique inert. Also the administration of 2-minute massage with no therapeutic effect prior to the treatment was used. The manual contact conducted for 12 x 15 minute treatments (three times weekly) over a 1-month period, and then one 15 minute session per week for the following 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 293599 0
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
Timepoint [1] 293599 0
three time intervals: baseline, 12 weeks, and 1 year after the 12 week follow up.
Secondary outcome [1] 311440 0
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.
Timepoint [1] 311440 0
three time intervals: baseline, 12 weeks, and 1 year after the 12 week follow up.
Secondary outcome [2] 311441 0
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.
Timepoint [2] 311441 0
three time intervals: baseline, 12 weeks, and 1 year after the 12 week follow up.
Secondary outcome [3] 311442 0
Algometric score
Algometric score (kg/cm2) was calculated as the average of the minimum pain-generating pressure values obtained from 18 points.
Timepoint [3] 311442 0
three time intervals: baseline, 12 weeks, and 1 year after the 12 week follow up.
Secondary outcome [4] 311443 0
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.
Timepoint [4] 311443 0
three time intervals: baseline, 12 weeks, and 1 year after the 12 week follow up.
Secondary outcome [5] 311444 0
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.
Timepoint [5] 311444 0
three time intervals: baseline, 12 weeks, and 1 year after the 12 week follow up.
Secondary outcome [6] 311445 0
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
Timepoint [6] 311445 0
three time intervals: baseline, 12 weeks, and 1 year after the 12 week follow up.

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patients were randomly assigned by means of a balanced stratified assignment to the experimental group or the control group. The groups were balanced for type of medication received and age by using a stratification system that generates a sequence of letters (from a table of correlatively ordered permutations) for each category and combination of categories. The sequences assigned to patients were placed in envelopes containing the allocation to each study group. An independent person, blinded to the research protocol and not otherwise involved in the trial, operated the random assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The groups were balanced for type of medication received and age by using a stratification system that generates a sequence of letters (from a table of correlatively ordered permutations) for each category and combination of categories. The sequences assigned to patients were placed in envelopes containing the allocation to each study group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
The required sample size was determined for the primary outcome variable, i.e. overall score of Fibromyalgia Impact Questionnaire . According to previous research, a clinically relevant change is a 15-20% reduction in the total Fibromyalgia Impact Questionnaire score (which equals to a ~10- 15 points reduction). We can detect differences of at least 15% with a power of 95% and a of 0.05 with two groups (intervention and usual care group) of 45 participants, with a mean in the Fibromyalgia Impact Questionnaire of ~70 and a standard deviation of ~20 points. Assuming a maximum loss of follow-up of 30%, we will recruit a total of 60 patients with fibromyalgia for each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/06/2012
Actual
7/08/2012
Date of last participant enrolment
Anticipated
Actual
2/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 6486 0
Egypt
State/province [1] 6486 0

Funding & Sponsors
Funding source category [1] 290274 0
Self funded/Unfunded
Name [1] 290274 0
Country [1] 290274 0
Primary sponsor type
Individual
Name
Ibrahim Moustafa Moustafa
Address
faculty of physical therapy- Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country
Egypt
Secondary sponsor category [1] 288983 0
None
Name [1] 288983 0
Address [1] 288983 0
Country [1] 288983 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291972 0
Ethics Committee of the Faculty of Physical Therapy, Cairo Univercity
Ethics committee address [1] 291972 0
Faculty of Physical Therapy - Cairo University 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Ethics committee country [1] 291972 0
Egypt
Date submitted for ethics approval [1] 291972 0
Approval date [1] 291972 0
03/04/2012
Ethics approval number [1] 291972 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52830 0
A/Prof Ibrahim Moustafa Moustafa
Address 52830 0
faculty of physical therapy- Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country 52830 0
Egypt
Phone 52830 0
+201227022334
Fax 52830 0
Email 52830 0
[email protected]
Contact person for public queries
Name 52831 0
A/Prof Ibrahim Moustafa Moustafa
Address 52831 0
faculty of physical therapy- Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country 52831 0
Egypt
Phone 52831 0
+201227022334
Fax 52831 0
Email 52831 0
[email protected]
Contact person for scientific queries
Name 52832 0
A/Prof Ibrahim Moustafa Moustafa
Address 52832 0
faculty of physical therapy- Cairo university 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Postal Code: 12612
Country 52832 0
Egypt
Phone 52832 0
+201227022334
Fax 52832 0
Email 52832 0
[email protected]

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