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Acupuncture vs. Core Stability Training in Women With Fibromyalgia

U

University of Extremadura

Status

Completed

Conditions

Fibromyalgia

Treatments

Other: Acupuncture
Other: Physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03638518
79/2013

Details and patient eligibility

About

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.

Full 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).

Enrollment

160 patients

Sex

Female

Ages

18 to 71 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • The exclusion criteria were to present any medical contraindication for acupuncture and/or physiotherapy, phobia of needles, adverse reactions to medication that could influence in balance, associated pathologies such as alcoholism or severe visual deficit, to have receive acupuncture or core stability based physiotherapy in the two months previous to the intervention and to do physical exercises that train core stability such as Pilates or Yoga

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

160 participants in 3 patient groups

Acupuncture
Experimental group
Description:
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.
Treatment:
Other: Acupuncture
Physiotherapy
Experimental group
Description:
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.
Treatment:
Other: Physiotherapy
control
No Intervention group
Description:
The control group did not receive any intervention. The participants continued with their routine medical treatment.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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