Acupuncture vs. Core Stability Training in Women With Fibromyalgia

NCT03638518 | Completed

• 1 other identifier: 79/2013
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fibromyalgia

Keywords

rehabilitation; balance; functional capacity; quality of life; pain; acupuncture

Outcome Measures

Primary Outcomes (7)

• 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

  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.

  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.

  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

  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.

  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.

  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.

  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

  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

  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

  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

  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

  Before treatment, after 5 weeks of treatment and after 6 weeks of follow up

Study Arms (3)

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.

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.

Other: Physiotherapy

control

NO INTERVENTION

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

Interventions

Acupuncture OTHER

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

Acupuncture

Physiotherapy OTHER

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

Physiotherapy

Eligibility Criteria

• Age: 18 Years - 71 Years
• Gender Eligibility Details: One of the inclusion criteria was to be a woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Extremadura: lead

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Acupuncture Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Rehabilitation

Study Officials

• Elisa Mª Garrido Ardila, Professor

  University of Extremadura

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor of Physiotherapy

Model Details: Participants were randomized to a core stability training physiotherapy programme group, an acupuncture treatment group and control group for a 13 week study.

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 20, 2018
• Study Start: January 7, 2014
• Primary Completion: April 30, 2015
• Study Completion: April 30, 2015
• Last Updated: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share