Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000780156p
Ethics application status
Submitted, not yet approved
Date submitted
12/04/2019
Date registered
27/05/2019
Date last updated
27/05/2019
Date data sharing statement initially provided
27/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of two forms of exercise therapy on pain intensity, central sensitisation and quantitative sensory testing in patients with fibromyalgia: a randomized clinical trial
Scientific title
Central sensitisation and quantitative sensory testing in patients with fibromyalgia: pain modification through a pilates and stretching intervention.
Secondary ID [1] 297949 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibromyalgia 312344 0
central sensitization 312345 0
Condition category
Condition code
Musculoskeletal 310908 310908 0 0
Other muscular and skeletal disorders
Neurological 311273 311273 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
People from the association will be informed about this study and will a receive a leaflet with information about the aim, content and duration of the study. Eligibility for study enrolment will be carried out by two physiotherapists with experience with working with patients with fibromyalgia. Study participants will sign an informed consent prior to the start of the study.

After study enrolment, participants will be allocated in either the ‘Pilates group’ or the ‘Stretching group’. Groups allocation (two groups of 30 patients) will be carried out by a computerised randomization program (randomized.com) that guarantees concealment for group allocation. A co-worker, not involved in this study will be responsible for this process. Baseline and outcome measures will be taken by physiotherapists blinded for group allocation. Analysis of study data will be carried out by a researcher not involved in this study.
The material used for the study was: a manual altimeter, a pressure cuff and electronic support for data recording. The physiotherapist who carried out the intervention was an outsider to whom he collected the data and different from the one who analyzed them. However, all physiotherapists are specialists in fibromyalgia.
Participants will complete a program of either Pilates or Stretching exercises for a period of three months.

Pilates group

A progressive exercise regimen will be given to the participants in the Pilates group. In the first month, sessions will consist of a set of specific Pilates exercises that will be repeated 6 times with a 40 second interval. During the following months, the number of repetitions will be increased to ten with only 15 seconds or rest between exercises. This program will follow the basic principles of the Pilates method with a special emphasis on movements with a low to intermediate difficulty. The frequency and duration of sessions will be 30 minute sessions, twice a week. The therapy will be surperved by a Pilates instructor with a degree in sports science and physiotherapy. The attendance and adherence of the treatment of each patient will be noted in a book of notes.
The performance protocol comprises several modules, which will be similar to those described by Altan: basic principles, breathing exercises, posture exercises, neutral position search, sitting exercises, antalgic exercises, stretching exercises and proprioceptivity exercises.

Stretching group

A stretching program targeting the following muscles will be given twice a week for 3 months: 1) paravertebral-, latissimus-, ischiotibial- ,gluteal muscles, hamstrings, hip adductors and triceps surae. Progression of stretching exercises in this group is: 3 repetitions in week 1 – 4, 4 repetitions in week 5 and 5 repetitions in week 6 – 12.
The study will be carry out in fibromyalgia association, Madrid , Spain.
Follow-up will be carried out in the assistance of patients to the study.
The therapy will be surperved by a Pilates instructor with a degree in sports science and physiotherapy. The attendance and adherence of the treatment of each patient will be noted in a book of notes
Intervention code [1] 314172 0
Rehabilitation
Comparator / control treatment

stretching
Control group
Active

Outcomes
Primary outcome [1] 319729 0
Pain intensity – Subjective pain evaluation will be measured using a Numerical Pain Rating Scale (NPRS).
Timepoint [1] 319729 0
Baseline, postreatment, first, second, third, fourth month and follow up sixth month.
Secondary outcome [1] 369314 0
Pressure Pain Thresholds – Pressure pain threshold (UDP). A manual gauge (Wagner Force Dial FDK will be used. The operator increases the pressure (expressed in kg / cm2) on the skin of the patient. the patient indicates when he has reached his pain threshold, and when the pressure exerted at that point begins to be painful. The operator registers the indicated value in the elastometer at that moment. The exploration of a painful point or tender point in fibromyalgia is performed by calculating the average of two measurements made with an interval of 30 seconds.
Timepoint [1] 369314 0
Baseline, postreatment, first, second, third, fourth month and follow up sixth month.
Secondary outcome [2] 369315 0
Temporal Summation – It is the result of the application of the pressure obtained according to the PPT in which, by means of a scale of numerical evaluation, the subject will reflect the subjective pain perceived in the first pressure in the fifth and in the tenth.
Timepoint [2] 369315 0
Baseline, postreatment, first, second, third, fourth month and follow up sixth month.
Secondary outcome [3] 369316 0
Conditioned Pain Modulation – Modulation of pain before an external pressure stimulus (CPM). To evaluate the conditioned modulation of pain (Kg / cm2), an occlusion cuff will inflate to a painful intensity and will remain at that level in the dominant arm (as a noxious conditioning stimulus). The cuff will inflate to approximately 20 mm / Hg / s to the point where the sensation becomes painful (participants will be asked to say "stop" at this point). Then, they will adapt for 30 seconds to the stimulus and subsequently qualify their pain in an EEN. The inflation of the bracelet will increase or decrease until the participant indicates that a level of pain equal to a score of 3/10 in an EEN is reached. The UDP in the second phalanx of the left index finger is measured before the inflation of the bracelet and while the cuff is inflated and the painful stimulus is given with an intensity of 3/10. The CPM value is calculated by subtracting the first value of the second value.
Timepoint [3] 369316 0
Baseline, postreatment, first, second, third, fourth month and follow up sixth month.
Secondary outcome [4] 369317 0
Quality of life – Quality of life questionnaire (SF-36). Aspects like physical, emotional, social, physical and emotional interference in the patient's roles, mental and general health, corporal pain, vitality, and evolution of health will be evaluated. The final score varies from 0 to 100, being that the higher the score, the greater the state of health.
Timepoint [4] 369317 0
Baseline, fourth and sixth month
Secondary outcome [5] 369318 0
Sleep quality – The Pittsburg Sleep Quality Index (PSQI) is composed of of 24 items. The 19 self-answering questions influence the subjective estimation of sleep duration, latency and severity of sleep problems. The evaluation period comprises only the month prior to the application of the questionnaire. Seven partial components are generated (subjective quality, latency, habitual efficiency, alterations in sleep, use of hypnotic medication and repercussion on daily activities). Each one receives a score of 0 to 3. The total score is the result of adding the 7 components with what the maximum possible score is 21 points. A score equal to or less than 5 corresponds to a "good sleeper", while results greater than 5 indicate a bad sleep.
Timepoint [5] 369318 0
Baseline, fourth and sixth month
Secondary outcome [6] 369319 0
Optimism – Optimism assessment questionnaire (LOT). It is a measure of the personality disposition of optimism in the face of pessimism. It has six content elements and produces a continuous distribution of 5 points ranging from "strongly disagree" to "strongly agree". The test consists of 10 items: three affirmations about optimism, three about pessimism and four distracting items whose results are not computed The subjects respond in each statement indicating their level of agreement on a five-point Likert scale ranging from "strongly disagree" to "totally agree".
Timepoint [6] 369319 0
Baseline, fourth and sixth month
Secondary outcome [7] 369429 0
Fibromyalgia impact questionnaire (FIQ). It consists of 10 items, each with a range of 4 points (from 0, always, to 3, never). This item assesses the functional capacity of the patient through questions about activities that relate to daily life. The second and third items correspond to numerical scales that refer to days of the week. The rest of the items are valued using visual analog scales ranging from 0 to 10.
Timepoint [7] 369429 0
Baseline, fourth and sixth months
Secondary outcome [8] 369430 0
Central Awareness Inventory (CSI). Self-reported questionnaire with strong psychometric properties that is clinically very useful.. This questionnaire consists of two parts. Part A evaluates 25 health-related symptoms that are common to central sensitization with scores ranging from 0 to 100. Part B asks if you have been diagnosed with one or more specific disorders including 7 own and characteristic of central sensitization
Timepoint [8] 369430 0
Baseline, fourth and sixth months

Eligibility
Key inclusion criteria
Adults diagnosed with Fibromyalgia according to the latest revision of criteria of the American College of Rheumatology (ACR).

• Pain with a minimum duration of 3 months.

• Able to read and understand the Spanish language.

• Men and women between the ages of 18 and 65.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presenting recent musculoskeletal injuries (less than 3 weeks).

Not have other diseases that represent a contraindication for the performance of therapeutic exercise.

Suffering from orthopedic, neurological, or cardiovascular comorbidities that prevent the development of a specific exercise program.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data will be analysed using SPSS-software. All variables will be summarized using appropriate statistics. Mean and standard deviations for continues data, Median and interquartile range for ordinal data and numbers and percentages for categorical data. In order to answer the primary research question, a mixed design repeated measure ANOVA will be used in order to describe both between and within group differences from baseline to follow-up. Level of significance will be set at 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/06/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 21399 0
Spain
State/province [1] 21399 0
Madrid

Funding & Sponsors
Funding source category [1] 302422 0
University
Name [1] 302422 0
Camilo Jose Cela University
Country [1] 302422 0
Spain
Primary sponsor type
Individual
Name
Edurne Úbeda
Address
Universidad Camilo José Cela
Castillo de Alarcón, 49
Villanueva de la Cañada
28692
Madrid
Country
Spain
Secondary sponsor category [1] 302322 0
None
Name [1] 302322 0
Address [1] 302322 0
Country [1] 302322 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303093 0
Camilo José Cela University
Ethics committee address [1] 303093 0
Castillo de Alarcón 49, 28692, Villanueva de la Cañada, Madrid
Ethics committee country [1] 303093 0
Spain
Date submitted for ethics approval [1] 303093 0
18/03/2019
Approval date [1] 303093 0
Ethics approval number [1] 303093 0

Summary
Brief summary
Participants will complete a program of Pilates or stretching sessions taught by a physiotherapist and licensed in Physical Activity and Sports. The program will consist of 30 minute sessions held twice a week for 4 months.
It is hypothesized that in patients with FM, exercise regimens should target the central nervous system and specifically should aim to desensitize the central nervous system. Earlier research has shown that doing exercises for a longer period indeed leads to reductions in CS-related signs and symptoms. However, it is unsure to date with exercises are most effective for this purpose.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92442 0
Dr Edurne Úbeda Docasar
Address 92442 0
Dra. Edurne Ubeda D´Ocasar / Universidad Camilo José Cela
Castillo de Alarcón,49
Villanueva de la Cañada
Madrid
Country 92442 0
Spain
Phone 92442 0
+34 918153131
Fax 92442 0
Email 92442 0
eubeda@ucjc.edu
Contact person for public queries
Name 92443 0
Dr Edurne Úbeda D´Ocasar
Address 92443 0
Universidad Camilo José Cela
Castillo de Alarcón,49
Villanueva de la Cañada, Madrid.
Country 92443 0
Spain
Phone 92443 0
+34 918153131
Fax 92443 0
Email 92443 0
eubeda@ucjc.edu
Contact person for scientific queries
Name 92444 0
Dr Edurne Úbeda Docasar
Address 92444 0
Dra. Edurne Ubeda D´Ocasar/ Universidad Camilo José Cela
Castillo de Alarcón,49
Vva de la Cañada
Madrid.
Country 92444 0
Spain
Phone 92444 0
+34 918153131
Fax 92444 0
Email 92444 0
eubeda@ucjc.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1850Study protocol    377346-(Uploaded-08-05-2019-21-05-49)-Study-related document.docx



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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