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Acupuncture vs. Core Stability Training in Women With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Physiotherapy
Sponsored by
University of Extremadura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring rehabilitation, balance, functional capacity, quality of life, pain, acupuncture

Eligibility Criteria

18 Years - 71 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Acupuncture

    Physiotherapy

    control

    Arm 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.

    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.

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

    Outcomes

    Primary Outcome Measures

    Change from the centre of gravity at 5 weeks and 13 weeks
    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
    Change from the monopodal stance test at 5 weeks and 13 weeks
    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.
    Change from Berg Balance Scale at 5 weeks and 13 weeks
    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.
    Change from Time Up and Go test at 5 weeks and 13 weeks
    Time up and Go test measures dynamic balance showed in seconds
    Change from 10 meter walk test at 5 weeks and 13 weeks
    10 meter walk test measures walking speed and performance which is related to dynamic balance. The unit use is meter/second.
    Change from Health Assessement Questionnaire at 5 weeks and 13 weeks
    Health Assessement questionnaire measures the functional capacity of a subject. It provides an impairment score of 0 to 3.
    Change from physical function item of the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks
    The physical function item of the Spanish Fibromyalgia Impact Questionnaire measures functional capacity with a score of 0 to 3.

    Secondary Outcome Measures

    Change from the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks
    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.
    Change from pain intensity levels measured with the visual analogue scale at 5 weeks and 13 weeks
    The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.
    Change from joint stiffness levels measured with the visual analogue scale at 5 weeks and 13 weeks
    The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.
    Change from depression level measured with the visual analogue scale at 5 weeks and 13 weeks
    The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.
    Change from perceived difficulty to work measured with the visual analogue scale at 5 weeks and 13 weeks
    The visual analogue scale is a 100-mm scale, where 0 indicated 'no difficulty' and 100 indicating 'extreme and unbearable difficulty'.

    Full Information

    First Posted
    August 14, 2018
    Last Updated
    April 1, 2021
    Sponsor
    University of Extremadura
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03638518
    Brief Title
    Acupuncture vs. Core Stability Training in Women With Fibromyalgia
    Official Title
    Effectiveness of Acupuncture vs. Core Stability Based Physiotherapy in Balance and Functional Capacity of Women With Fibromyalgia: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 7, 2014 (Actual)
    Primary Completion Date
    April 30, 2015 (Actual)
    Study Completion Date
    April 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Extremadura

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia
    Keywords
    rehabilitation, balance, functional capacity, quality of life, pain, acupuncture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants were randomized to a core stability training physiotherapy programme group, an acupuncture treatment group and control group for a 13 week study.
    Masking
    Outcomes Assessor
    Masking Description
    Neither the participants nor their therapists were blind to the treatment allocation. However, the assessor was independent to the study and was not aware of the treatments applied or the objective of the therapy.
    Allocation
    Randomized
    Enrollment
    160 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Physiotherapy
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    The control group did not receive any intervention. The participants continued with their routine medical treatment.
    Intervention Type
    Other
    Intervention Name(s)
    Acupuncture
    Intervention Description
    Acupuncture 5 weeks treatment. 2 sessions a week (30 minutes each session)
    Intervention Type
    Other
    Intervention Name(s)
    Physiotherapy
    Intervention Description
    Core stability exercises programme. 2 sessions a week (30 minutes each session) during 5 weeks
    Primary Outcome Measure Information:
    Title
    Change from the centre of gravity at 5 weeks and 13 weeks
    Description
    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
    Time Frame
    Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
    Title
    Change from the monopodal stance test at 5 weeks and 13 weeks
    Description
    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.
    Time Frame
    Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
    Title
    Change from Berg Balance Scale at 5 weeks and 13 weeks
    Description
    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.
    Time Frame
    Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
    Title
    Change from Time Up and Go test at 5 weeks and 13 weeks
    Description
    Time up and Go test measures dynamic balance showed in seconds
    Time Frame
    Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
    Title
    Change from 10 meter walk test at 5 weeks and 13 weeks
    Description
    10 meter walk test measures walking speed and performance which is related to dynamic balance. The unit use is meter/second.
    Time Frame
    Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
    Title
    Change from Health Assessement Questionnaire at 5 weeks and 13 weeks
    Description
    Health Assessement questionnaire measures the functional capacity of a subject. It provides an impairment score of 0 to 3.
    Time Frame
    Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
    Title
    Change from physical function item of the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks
    Description
    The physical function item of the Spanish Fibromyalgia Impact Questionnaire measures functional capacity with a score of 0 to 3.
    Time Frame
    Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
    Secondary Outcome Measure Information:
    Title
    Change from the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks
    Description
    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.
    Time Frame
    Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
    Title
    Change from pain intensity levels measured with the visual analogue scale at 5 weeks and 13 weeks
    Description
    The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.
    Time Frame
    Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
    Title
    Change from joint stiffness levels measured with the visual analogue scale at 5 weeks and 13 weeks
    Description
    The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.
    Time Frame
    Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
    Title
    Change from depression level measured with the visual analogue scale at 5 weeks and 13 weeks
    Description
    The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'.
    Time Frame
    Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
    Title
    Change from perceived difficulty to work measured with the visual analogue scale at 5 weeks and 13 weeks
    Description
    The visual analogue scale is a 100-mm scale, where 0 indicated 'no difficulty' and 100 indicating 'extreme and unbearable difficulty'.
    Time Frame
    Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    One of the inclusion criteria was to be a woman
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    71 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elisa Mª Garrido Ardila, Professor
    Organizational Affiliation
    University of Extremadura
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Acupuncture vs. Core Stability Training in Women With Fibromyalgia

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