FibromyalgiaNCT03638518
Acupuncture vs. Core Stability Training in Women With Fibromyalgia
A study testing Acupuncture and Physiotherapy in people with Fibromyalgia, run by University of Extremadura.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 71 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Acupuncture and Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2014to 30 Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 71 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women between 18 and 71 years old,
- diagnosed with Fibromialgia by a specialized physician,
- having subjective sensation of balance impairments.
Who cannot join
- 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
About this study
Official title: Effectiveness of Acupuncture vs. Core Stability Based Physiotherapy in Balance and Functional Capacity of Women With Fibromyalgia: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Acupuncture, Physiotherapy
- Keywords
- rehabilitation, balance, functional capacity, quality of life, pain, acupuncture
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture 5 weeks treatment. 2 sessions a week (30 minutes each session)
PhysiotherapyOther
Core stability exercises programme. 2 sessions a week (30 minutes each session) during 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | 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. Receives: Other: Acupuncture |
| Physiotherapy | Experimental | 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. Receives: Other: Physiotherapy |
| control | No intervention | The control group did not receive any intervention. The participants continued with their routine medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
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.
Measured: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
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.
Measured: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Change from Time Up and Go test at 5 weeks and 13 weeks
Time up and Go test measures dynamic balance showed in seconds
Measured: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
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.
Measured: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
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.
Measured: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
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.
Measured: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Secondary outcomes (5)
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.
Measured: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
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'.
Measured: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
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'.
Measured: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
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'.
Measured: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
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'.
Measured: Before treatment, after 5 weeks of treatment and after 6 weeks of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start7 Jan 2014
- Primary completion30 Apr 2015
- Study completion30 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa María Garrido Ardila, University of Extremadura
- Investigators
- Elisa Mª Garrido Ardila, Professor, Principal investigator, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638518
- Sponsor's protocol ID
- 79/2013
- Status last verified
- Apr 2021
- First submitted
- 14 Aug 2018
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acupuncture vs. Core Stability Based Physiotherapy in Balance and Functional Capacity of Women With Fibromyalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03638518
- Acronym / sponsor ID
- 79/2013
- Conditions
- Fibromyalgia
- Keywords
- rehabilitation, balance, functional capacity, quality of life, pain, acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 7 Jan 2014 (actual)
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: AcupunctureIn 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. |
| Physiotherapy | Experimental | Other: PhysiotherapyThe 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. |
| control | No intervention | –The control group did not receive any intervention. The participants continued with their routine medical treatment. |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women between 18 and 71 years old,
- diagnosed with Fibromialgia by a specialized physician,
- having subjective sensation of balance impairments.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture 5 weeks treatment. 2 sessions a week (30 minutes each session) | Other | Acupuncture |
| PhysiotherapyCore stability exercises programme. 2 sessions a week (30 minutes each session) during 5 weeks | Other | Physiotherapy |
Primary outcome
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
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.
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.
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
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.
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.
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Mª Garrido Ardila, Professor principal investigator
University of Extremadura
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Physiotherapy in people with Fibromyalgia, run by University of Extremadura.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.