Condition category
Musculoskeletal Diseases
Date applied
21/12/2011
Date assigned
17/02/2012
Last edited
14/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Fibromyalgia syndrome (FMS) is a long-term condition that causes pain all over the body. Rehabilitation has an important role in the treatment of FMS. Mind body therapies (MBT) are treatments that facilitate the mind’s capacity to affect bodily function and symptoms. Among the different MBT utilized in FMS, the Rességuier method (RM) and Qi Gong (QG) have been shown to relieve FMS symptoms when used alone. QG integrates body, energetic, respiratory, and mental training and improves posture, breathing and concentration by low impact movements. RM aims to obtain patient awareness and control of bodily perceptions, thus reaching a modulation of responses to pain. The aim of our study is to evaluate the effectiveness of two protocols sequentially integrating RM and QG: the first using RM first and then QG (RM to QG) and the second using QG and then RM (QG to RM).

Who can participate?
The study includes female patients aged over 18 with FMS.

What does the study involve?
Participants are randomly allocated to either group 1 or group 2. Group 1 patients are treated first with RM for 7 weeks and, after a break of 1 week, with QG. Group 2 patients are treated with QG for 7 weeks and, after a break of 1 week, with RM. All patients are assessed at the start of the study, at the end of the first and second treatments, and after 9 weeks of follow-up. At each study point, patients are evaluated for pain, disability, tender points, quality of life, anxiety, depression, and quality of sleep.

What are the possible benefits and risks of participating?
Patients treated with both protocols are expected to improve in FMS-related symptoms, such as disability, pain, local tenderness, disturbed sleep and mood alterations. QG and RM are rehabilitative techniques with a soft approach, thus they are generally safe and do not cause adverse effects.

Where is the study run from?
Division of Rheumatology of the Department of Biomedicine of Florence University (Italy).

When is the study starting and how long is it expected to run for?
The study started in April 2011 and ran for about 7 months. The trial recruited participants for 2 months.

Who is funding the study?
University of Florence (Italy).

Who is the main contact?
Dr Susanna Maddali Bongi
susanna.maddalibongi@unifi.it

Trial website

Contact information

Type

Scientific

Primary contact

Dr Susanna Maddali Bongi

ORCID ID

Contact details

Department of Biomedicine
University of Florence
viale G. Pieraccini 18
Florence
50139
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Rességuier and Qi Gong methods applied sequentially in patients with fibromyalgia syndrome: a randomised controlled trial

Acronym

Study hypothesis

Rehabilitation has an important role in the treatment of fibromyalgia syndrome (FMS). Despite numerous studies, an agreement on a specific rehabilitation line has not been found yet.

Mind body therapies (MBT), defined as 'interventions that use a variety of techniques designed to facilitate the mind’s capacity to affect bodily function and symptoms' may be useful in the rehabilitative therapy of FMS. Among the different MBT utilized in FMS, the Rességuier method (RM) and Qi Gong (QG) have shown efficacy on FMS symptoms when used alone. Hereby, we propose two rehabilitation protocols integrating sequentially RM and QG for the non-pharmacological treatment of FMS patients.

Ethics approval

Ethics Committee of Azienda University Hospital Careggi, Italy [Comitato Etico Azienda Ospedaliera Universitaria Careggi (AOUC)], ref: 673/11

Study design

Randomised controlled single centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Fibromyalgia syndrome

Intervention

30 FMS patients are recruited and randomly assigned to the Group A and Group B.

Group A:
15 patients, treated firstly with RM for 7 weeks (two sessions per week in the first 3 weeks and once per week in weeks 4-7 = total of 10 sessions). After a 1-week break, patients are treated with QG for 7 weeks (two sessions per week in the first 3 weeks and once per week in weeks 4-7 = total of 10 sessions).

Group B:
15 patients, treated firstly with QG for 7 weeks (two sessions per week in the first 3 weeks and once per week in weeks 4-7 = total of 10 sessions). After a 1-week break, patients are treated with RM for further 7 weeks (two sessions per week in the first 3 weeks and once per week in weeks 4-7 = total of 10 sessions).

Total duration of the study: 27 weeks, divided into 15 weeks of intervention (7 weeks for each method, with an interval of 1 week between the two techniques) and 12 weeks of follow up.
All patients are assessed at baseline (T0), at the end of treatment (week 15: T1) and after 12 weeks of follow-up (week 27: T2).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The following items are assessed at baseline (T0), at end of the first (week 7: T1) and the second treatment (week 15: T2) and after 9 weeks of follow-up (week 27: FU):
1. Pain assessed by regional pain scale (RPS)
2. Disability assessed by Fibromyalgia Impact Questionnarie (FIQ) and Health Assessment Questionnaire (HAQ)

Secondary outcome measures

The following items are assessed at baseline (T0), at end of the first (week 7: T1) and the second treatment (week 15: T2) and after 9 weeks of follow-up (week 27: FU):
1. Tenderness in specific FMS sites (by the tender points evaluation)
2. Quality of life by Medical Outcomes Survey Short Form 36 (SF-36)
3. Anxiety and Depression by Hospital Anxiety and Depression Scale (HADS), with subscales for anxiety (HADS-a) and depression (HADS-d)
4. Quality of sleep by a number rating scale 0–10 (NRS- 0–10)

Overall trial start date

01/04/2011

Overall trial end date

15/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Diagnosis of fibromyalgia syndrome according to the American College of Rheumatology (ACR) criteria

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 patients

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2011

Recruitment end date

15/11/2011

Locations

Countries of recruitment

Italy

Trial participating centre

Department of Biomedicine
Florence
50139
Italy

Sponsor information

Organisation

University of Florence (Italy)

Sponsor details

Department of Biomedicine
viale G. Pieraccini 18
Florence
50139
Italy

Sponsor type

University/education

Website

http://www.unifi.it

Funders

Funder type

University/education

Funder name

University of Florence (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes