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Completed

NCT Number: NCT03638518

Acupuncture vs. Core Stability Training in Women With Fibromyalgia

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

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

Physiotherapy

Other

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

Primary outcomes

  1. Change from the centre of gravity at 5 weeks and 13 weeks

    Time frame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

    Static balance and postural control is the ability to maintain the centre of gravity within the base of support. Centre of gravity is measured in percentage through posturography study

  2. Change from the monopodal stance test at 5 weeks and 13 weeks

    Time frame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

    Static balance and postural control is the ability to maintain the centre of gravity within the base of support. Monopodal stance test measures static balance in percentage through posturography study.

  3. Change from Berg Balance Scale at 5 weeks and 13 weeks

    Time frame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

    Dynamic balance is the ability to maintain the centre of gravity within the base of support during the performance of functional activities. Berg Balance scale measures dynamic balance through performing multiple tasks and with a score of 0 to 56.

  4. Change from Time Up and Go test at 5 weeks and 13 weeks

    Time frame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

    Time up and Go test measures dynamic balance showed in seconds

  5. Change from 10 meter walk test at 5 weeks and 13 weeks

    Time frame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

    10 meter walk test measures walking speed and performance which is related to dynamic balance. The unit use is meter/second.

  6. Change from Health Assessement Questionnaire at 5 weeks and 13 weeks

    Time frame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

    Health Assessement questionnaire measures the functional capacity of a subject. It provides an impairment score of 0 to 3.

  7. Change from physical function item of the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks

    Time frame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

    The physical function item of the Spanish Fibromyalgia Impact Questionnaire measures functional capacity with a score of 0 to 3.

Secondary outcomes

  1. Change from the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks

    Time frame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

    The Spanish Fibromyalgia Impact Questionnaire measures the quality of life and the impact of Fibromyalgia on the life of persons diagnosed with this condition. The maximum score is 100 and the higher the result obtained, the higher the impact of the condition on the person and the less quality of life he/she has.

  2. Change from pain intensity levels measured with the visual analogue scale at 5 weeks and 13 weeks

    Time frame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

    The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.

  3. Change from joint stiffness levels measured with the visual analogue scale at 5 weeks and 13 weeks

    Time frame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

    The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.

  4. Change from depression level measured with the visual analogue scale at 5 weeks and 13 weeks

    Time frame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

    The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.

  5. Change from perceived difficulty to work measured with the visual analogue scale at 5 weeks and 13 weeks

    Time frame: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

    The visual analogue scale is a 100-mm scale, where 0 indicated 'no difficulty' and 100 indicating 'extreme and unbearable difficulty'.

Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Official study title

Effectiveness of Acupuncture vs. Core Stability Based Physiotherapy in Balance and Functional Capacity of Women With Fibromyalgia: A Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 20, 2018
Registry last updated
Apr 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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