Acupuncture vs. Core Stability Training in Women With Fibromyalgia

NCT ID: NCT03638518

Last Updated: 2021-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-07
• Study Completion Date: 2015-04-30

Brief Summary

This study analyse the effectiveness of a core stability training Physiotherapy programme versus Acupuncture treatment for the management of balance and functional capacity impairments of women with Fibromyalgia.

Detailed Description

Objective:

This study investigated the effectiveness of a core stability training Physiotherapy programme versus Acupuncture for the management of balance and functional capacity impairments of women with Fibromyalgia.

Design:

A single-blind randomized clinical controlled trial.

Setting:

University of Extremadura and Olivenza Fibromyalgia Association, Spain

Subjects:

Women with Fibromyalgia and balance impairment.

Interventions:

135 Participants were randomized to a core stability training physiotherapy programme group (n=45), an acupuncture treatment group (n=45) and control group (n=45) for 13 weeks.

Main Measures:

Measures were taken at baseline (week 0), post intervention (week 6) and at follow up (week 13). The primary outcome measures were static balance (posturography) and dynamic balance and functional mobility (Berg Balance Test, Time Up and Go test and 10-metre walk) and functional capacity (Fibromyalgia Health Assessment Questionnaire (FHAQ) and the physical function item from the Spanish Fibromyalgia Impact Questionnaire (SFIQ)).The secondary outcome measure were quality of life (Spanish- Fibromyalgia Impact Questionnaire), pain, joint stiffness, difficulty to work and depression (measured with the visual analogue scale).

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acupuncture

In the acupuncture experimental group, the technique applied included the use of the following acupuncture points of Traditional Chinesse Medicine: GV20, ST36 and BL60 . One needle insertion was performed in each session and in the case of the last two points the needle insertions were done bilaterally.

Patients laid supine on a treatment table with their legs exposed. The skin on the acupuncture points was prepared with 70% ethyl alcohol. One-time-use disposable sterile stainless steel needles (0,26x50mm) were inserted into acupuncture points.

After insertion, acupuncture needles were manually manipulated to obtain the de qi sensation. The needles remained in place for 20 minutes and there were no further manipulations during the retention time.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

Acupuncture 5 weeks treatment. 2 sessions a week (30 minutes each session)

Physiotherapy

The physiotherapy experimental group received core stability based physiotherapy treatment. Before the beginning of the treatment sessions, the basic principles of core stability exercises were explained to the participants. The exercise programme included 7 exercises. The exercises in the crook lying position were core activation with breathing, single leg lift with knees bent, single leg slides, bridging and knee drop sideways. The exercises completed in side lying included hip external rotation with knees bent and hip abduction with knees straight. After each session gentle stretching of the lower limbs and lumbar spine were performed. The sessions were administered twice a week during 30 minutes with groups of no more than 8 people.

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: OTHER

Core stability exercises programme. 2 sessions a week (30 minutes each session) during 5 weeks

control

The control group did not receive any intervention. The participants continued with their routine medical treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupuncture

Acupuncture 5 weeks treatment. 2 sessions a week (30 minutes each session)

Intervention Type: OTHER

Physiotherapy

Core stability exercises programme. 2 sessions a week (30 minutes each session) during 5 weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• women between 18 and 71 years old,
• diagnosed with Fibromialgia by a specialized physician,
• having subjective sensation of balance impairments.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 71 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Extremadura

OTHER

Sponsor Role: lead

Responsible Party

Elisa María Garrido Ardila

Profesor of Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisa Mª Garrido Ardila, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Extremadura

Other Identifiers

79/2013

Identifier Type: -

Identifier Source: org_study_id