Ai Chi Versus Stretching in Fibromyalgia Management

Fibromyalgia Clinical Trial

Official title:

A Randomized Controlled Trial Comparing the Efficay and Tolerability of Ai Chi Versus Stretching in Fibromyalgia Management: a Six Months Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600574
• Other study ID #: ML-2007
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2008
• Last updated: December 1, 2014
• Start date: January 2007
• Est. completion date: February 2008

Study information

• Verified date: December 2014
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare the efficacy and tolerability of Ai Chi, an adaptation of Tai Chi exercise to water, with stretching on fibromyalgia symtomatology.

Description:

Physical therapies have shown to be effective in the treatment of fibromyalgia and It is generally assumed that a multidisciplinary approach, combining both pharmacologic and non-pharmacologic measures, is probably the optimal treatment approach for most fibromyalgia patients. As these patients are usually physically deconditioned, low-intensity exercise has been recommended at least as initial treatment. At this respect, exercise in warm water is considered a good option as both temperature and water buoyancy minimize body weight's stress and help patients to minimize pain. In a previous study comparing short term physiotherapy with stretching and Ai Chi we found that Ai Chi was at least as effective as stretching and induced a significant reduction in fibromyalgia core symptomatology and in sleep parameters. The objective of the present randomized controlled study is to compare both physiotherapy techniques in a long term basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• diagnosis of fibromyalgia according to the ACR criteria

• 18 years or older

• written informed consent to participate

Exclusion Criteria:

• unable to tolerate warm chlorinated water

• associated medical condition contraindicating exercise in warm water

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• physical therapy
weekly pool physiotherapy with muscle stretching
• physical therapy
weekly pool physiotherapy with Ai Chi movements during a 6 months period

Locations

Country	Name	City	State
Spain	Hospital Universitario "Virgen de las Nieves"	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Gowans SE, deHueck A. Pool exercise for individuals with fibromyalgia. Curr Opin Rheumatol. 2007 Mar;19(2):168-73. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromialgya Impact Questionnaire		baseline, 6 months, 1 year	No
Secondary	Pittsbugh Sleep Quality Index		baseline, 6 months, 12 months	No
Secondary	Hospital Anxiety and Depression Scale		baseline, 6 months, 12 months	No
Secondary	SF-36 Health Survey		baseline, 6 months, 12 months	No
Secondary	Brief Pain Inventory		baseline, 6 months, 12 months	No
Secondary	Adverse reaction recording		baseline, 6 months, 12 months	No