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FibromyalgiaNCT03705910

Effects of Mobilization and Perceptive Rehabilitation on Patients With Fibromyalgia Syndrome

A study testing Perceptive Rehabilitation and Mobilisation Techniques in people with Fibromyalgia, run by European University of Lefke at 1 site in Cyprus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of our study is to determine and compare the effects of perceptive rehabilitation against other mobilization techniques on the treatment of fibromyalgia symptoms and disability. Read more about this study

Who is it for?
Ages 25 to 55 years
Conditions the study is for
Fibromyalgia
What is being tested?
Perceptive Rehabilitation and Mobilisation Techniques
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteCyprus
Study dates
6 Nov 2018to 30 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • •Having a Fibromyalgia diagnosis according to Wolfe et al. (2016) criteria.

Who cannot join

  • Having a diagnosis of chronic fatigue syndrome or myofascial pain syndrome,
  • Using medicine other than simple analgesics,
  • Vertebrobasilar insufficiency,
  • Severe scoliosis or kyphoscoliosis,
  • History of spine surgery,
  • History of vertebral fracture,
Show all 15Show fewer
  • Rheumatic diseases,
  • History of Benign or Malign tumour,
  • Osteoporosis and conditions that cause osteoporosis,
  • Presence of cardiovascular risk factors,
  • Serious neurological problems,
  • Psychiatric disorders,
  • Chronic respiratory diseases,
  • After upper motor neurone lesion,
  • Attending regular physical activity or exercise class during the last 3 months.

Trial locations and contacts

1 site in 1 country.

Cyprus1 site

  • Eastern Mediterranean University

    Famagusta

Other trials in Cyprus

About this study

Official title: Effects of Mobilization and Perceptive Rehabilitation on Disability and Symptoms of Patients With Fibromyalgia Syndrome- A Randomised Controlled Trial

The aim of our study is to determine and compare the effects of perceptive rehabilitation against other mobilization techniques on the treatment of fibromyalgia symptoms and disability. Participants in this study will be randomly assigned to three separate groups using a random allocation software program, the three groups receiving either perceptive rehabilitation (PR-group), mobilization techniques (Mob-group), or neither (the control group, C-group).

Read the detailed description

Fibromyalgia is considered to be a chronic, widespread musculoskeletal pain syndrome. Its most common symptoms are fatigue, anxiety, depression, and lack of concentration. These symptoms may lead to a decrease in the amount of physical activity that a sufferer can accomplish. Neck and back pain will also increase as the sedentary behaviour becomes the norm (Talotta et al., 2017). The best overall way of managing fibromyalgia is still under discussion, but according to the literature, symptoms are best managed by physiotherapy (García, Nicolás, and Hernández, 2016). Different programs can also be tailored to individual fibromyalgia sufferers with the aim of reducing pain (e.g. heat agents, electrotherapy, postural exercises, aerobic exercise, aqua-therapy and manual treatment).

However, according to Bronfort et al. (2010), there is insufficient evidence supporting the effectiveness of manual therapy as a treatment for fibromyalgia. According to Reis et al. (2014), a single thoracic mobilization session was able to improve short-term heart-rate variability, although the pain was not affected by the intervention.

Paolucci et al. (2016) used a new rehabilitation tool to treat pain with an increased reliance on proprioception. Practically, the tool consisted of cones made from a latex material which were placed under the patient's back during treatment sessions. These cones were intended to improve tactile response and proprioception, the so-called perceptual surface. According to this study, the tool was able to decrease pain and help to improve function. However, it is important to understand the tool's effect on long-term rehabilitation and compare it with other treatment methods. The aim of our study is to determine and compare the effects of perceptive rehabilitation and mobilization techniques on disability and fibromyalgia symptoms.

Our study will include 90 participants, with 30 participants in each group. The PR-group and the Mob-group will receive treatments twice per week for eight weeks, a total of 16 sessions; there will be no intervention in the C-group. Another physiotherapist will assess each group before and after all the sessions. The study will be single blind. Follow-up assessments will be three and six months after the last session.

Conditions
Fibromyalgia
Being tested
Perceptive Rehabilitation, Mobilisation Techniques
Keywords
proprioception, manual therapies, pain, health status, posture, sleep, fatigue, depression
Medical subject headings
Fibromyalgia, Pain, Fatigue, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perceptive RehabilitationOther

    In each session, over one hundred cones will be placed on a rigid wooden base using elastic strips. The patient will be asked to lie down supine on the material. Patients weigh will create pressure and reaction force to his/her body. Treatments will be 2 times a week till 8 weeks.

    The therapist will ask the patient firstly to breathe normally and feel the pressure. The patient will then perform breathing exercises and active exercises (including stretching, warming up, and cooling down) under supervision. During the session, the therapist will ask about the pressure of the cones and will correct the patient's posture. At the end of each session, the therapist will photograph the patient's back with the aim of documenting the pressure and hyperaemic areas.

  • Mobilisation TechniquesOther

    A certified physiotherapist will perform mobilisation techniques. All participants in this group will receive treatment protocol according to the list on below. Treatments will be 2 times a week till 8 weeks.

    For this treatment, the participant should lie on a bed and change their position according to the technique (supine, position or side-lying). Also, the therapist will be changing her position according to the technique. All technique will be on the range of motion limit. For releasing techniques the therapist will apply three-dimensional pressures till 3-5 minutes, with the feeling of relaxing therapist will change the limit for the next point.

Study groups in NCT03705910
Study groupRoleWhat they receive
Perceptive Rehabilitation (PR-group)Active comparatorThis treatment will include small latex cones with different resistance. In each session, over one hundred cones will be placed on a rigid wooden base using elastic strips. The patient will be asked to lie down supine on the material. Patients weigh will create pressure and reaction force to his/her body. Treatments will be 2 times a week till 8 weeks. The therapist will ask the patient firstly to breathe normally and feel the pressure. The patient will then perform breathing exercises and active exercises (including stretching, warming up, and cooling down) under supervision. During the session, the therapist will ask about the pressure of the cones and will correct the patient's posture.
Receives: Other: Perceptive Rehabilitation
Mobilisation Techniques (Mob-group)Active comparatorA certified physiotherapist will perform mobilisation techniques. All participants in this group will receive treatment protocol according to the list on below. Treatments will be 2 times a week till 8 weeks. For this treatment, the participant should lie on a bed and change their position according to the technique (supine, position or side-lying). Also, the therapist will be changing her position according to the technique. All technique will be on the range of motion limit. For releasing techniques the therapist will apply three-dimensional pressures till 3-5 minutes, with the feeling of relaxing therapist will change the limit for the next point.
Receives: Other: Mobilisation Techniques
Control Group (C-group)No interventionThis group will not receive any intervention during this period. C-group will attend assessments.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Revised-Fibromyalgia Impact Questionnaire (FIQR)

    Turkish version of FIQR will be use in this study. This questionnaire has 21 individual questions. All these questions should be answered according to the past 7 days. FIQR has divided to three sections; 'function, overall impact and symptoms'. The total FIQR score will be calculate with the sum of the three domain scores.

    Measured: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

Secondary outcomes (11)

  1. Socio-demographic and clinical characteristics

    Date of birth, sex, marital status, profession, education status, medical histories, medications, time period of body pain, time of the diagnosis of FMS, symptoms, when pain increases, which activities increases pain and complaints will be noted.

    Measured: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

  2. Body Mass Index (BMI)

    Weight and height will be combined to report BMI in kg/m^2.

    Measured: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

  3. Postural assessment 1

    New York Posture Rating Chart will be used to evaluate the posture. These evaluations will be on anterior, posterior and both lateral sides of the body. Therapist will give numerous rating for any deformities that can be seen. A score is allocated to each area according to the position: 5 points to the correct position; 3 points for a slight deviation, and 1 point for a pronounced deviation. Total score is between 18-90 points. Higher the points better the postural alignment.

    Measured: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

  4. Postural assessment 2

    Posture Grid will be used to evaluate the posture. These evaluations will be on anterior, posterior and both lateral sides of the body. Therapist will note any deformities that can be seen.

    Measured: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

  5. Cervical flexibility tests

    Cervical flexibility will be assessed in flexion, extension, rotation and lateral flexion according to Armiger \& Martyn (2010).

    Measured: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

  6. Cervical joint position sense

    The patient will have a small laser pointer mounted onto a lightweight headband, which they will wear. The patient will be seated 100 cm from the wall. Measurements will be noted on the graph paper. The starting point that is projected by the laser on the graph paper will be marked. First the patients will perform active neck movements with eyes open and than eyes closed. After movement, the patient will return their head as accurately as possible to the starting position. This will include 3 trials, which will include cervical flexion, lateral flexion. The final laser position is measured against the starting position in centimetres.

    Measured: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

  7. Pressure pain threshold and toleration

    Pressure algometer will be used to assess pain threshold and toleration. Measurements will be taken from both side of the body (low cervical region, second rib, occiput, trapezius muscle and supraspinatus muscle).

    Measured: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

  8. Short form of McGill pain questionnaire (SF-MPQ)

    Turkish version of Short form of McGill pain questionnaire (SF-MPQ) will be used in this study. The main section of this questionnaire includes 15 words that describe pain. Patients should mark these words according to their pain intensities on a rating scale (0:none, 1:mild, 2:moderate, 3:severe). Next section of the SF-MPQ is measurement of pain intensity according to the visual analogue scale (VAS). The last section is the evaluative total pain intensity. The total score of the main component is derived by adding the rank values given by the patient for each descriptor out of 45. Scores can range from 0 to 45. A higher score of the main component of the SF-MPQ reflects more serious pain.

    Measured: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

  9. Beck Depression Inventory (BDI)

    Turkish version of Beck Depression Inventory (BDI) will be used in this study. This inventory has 21 self-report items about depressive symptoms. All items should be answered from 0 through 3. The higher score represents the more intensity of the symptom. Items should be answered according to the past 2 weeks. The total score on the BDI, which has a range of 0 to 63. Higher values represent greater severity of depression (0-9 minimal depression 10-18 mild depression 19-29 moderate depression 30-63 severe depression).

    Measured: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

  10. Fatigue Severity Scale (FSS)

    Turkish version of Fatigue Severity Scale (FSS) will be used in this study. This scale has 9 items. Each item should be scored (strongly disagrees) 0 to 7 (strongly agrees). The minimum score=9 and maximum score possible=63. Higher score=greater fatigue severity. The average score for all 9 items constitutes the FSS score.

    Measured: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

  11. Pittsburgh Sleep Quality Index (PSQI)

    Turkish version of Pittsburgh Sleep Quality Index (PSQI) will be used in this study. This is a self-reported index that has 19 items with Likert and open-ended response formats. This index should be answered according to the past month. Minimum Score "0" means "good sleep" and Maximum Score "21" means "disrupted sleep".

    Measured: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2018
  2. Study start6 Nov 2018
  3. Primary completion30 May 2023
  4. Study completion30 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03705910
Sponsor's protocol ID
ETK00-2018-0206
Status last verified
Jun 2023
First submitted
7 Oct 2018
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bronfort G, Haas M, Evans R, Leininger B, Triano J. Effectiveness of manual therapies: the UK evidence report. Chiropr Osteopat. 2010 Feb 25;18:3. doi: 10.1186/1746-1340-18-3.

    PubMed 20184717

  • Angel Garcia D, Martinez Nicolas I, Saturno Hernandez PJ. "Clinical approach to fibromyalgia: Synthesis of Evidence-based recommendations, a systematic review". Reumatol Clin. 2016 Mar-Apr;12(2):65-71. doi: 10.1016/j.reuma.2015.06.001. Epub 2015 Oct 16. English, Spanish.

    PubMed 26481494

  • Paolucci T, Baldari C, Di Franco M, Didona D, Reis V, Vetrano M, Iosa M, Trifoglio D, Zangrando F, Spadini E, Saraceni VM, Guidetti L. A New Rehabilitation Tool in Fibromyalgia: The Effects of Perceptive Rehabilitation on Pain and Function in a Clinical Randomized Controlled Trial. Evid Based Complement Alternat Med. 2016;2016:7574589. doi: 10.1155/2016/7574589. Epub 2016 Jan 13.

    PubMed 26884794

  • Reis MS, Durigan JL, Arena R, Rossi BR, Mendes RG, Borghi-Silva A. Effects of posteroanterior thoracic mobilization on heart rate variability and pain in women with fibromyalgia. Rehabil Res Pract. 2014;2014:898763. doi: 10.1155/2014/898763. Epub 2014 May 29.

    PubMed 24991436

  • Talotta R, Bazzichi L, Di Franco M, Casale R, Batticciotto A, Gerardi MC, Sarzi-Puttini P. One year in review 2017: fibromyalgia. Clin Exp Rheumatol. 2017 May-Jun;35 Suppl 105(3):6-12. Epub 2017 Jun 28.

    PubMed 28681712

  • Alptug B, Tuzun EH, Kececi B, Eker L. Effects of perceptive rehabilitation and mobilization methods on symptoms and disability in patients with fibromyalgia: A preliminary randomized control trial. Ir J Med Sci. 2023 Dec;192(6):2937-2947. doi: 10.1007/s11845-023-03333-6. Epub 2023 Mar 10.

    PubMed 36897535

Questions about this trial

What is this clinical trial studying?

A study testing Perceptive Rehabilitation and Mobilisation Techniques in people with Fibromyalgia, run by European University of Lefke at 1 site in Cyprus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Revised-Fibromyalgia Impact Questionnaire (FIQR) (time frame: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03705910, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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