Effects of Acupuncture on Pain and Quality of Life of People Affected With Chronic Widespread Pain.

Summary

Background: Chronic Widespread Pain (CWP) is a multidimensional disorder for which treatment as yet remains unsatisfactory. Acupuncture is one of the most sought therapeutic methods when it comes to alternative medicine, due to its minimal adverse effects and its ease of use in clinical practice. Currently, acupuncture is successfully used in China for the treatment of many chronic diseases. The work to be carried out aims to assess the effects of acupuncture on pain management and quality of life of people suffering from CWP.

Methods/design: The study is a single-center, controlled triple-blind prospective study. A total of 100 participants will be randomly distributed into two groups, the intervention group, which will receive an individualized acupuncture treatment; and control group, which will receive sham acupuncture. The treatments performed will be personalized and the treatment criteria will be based on the use of the Yuan and Luo points. They will be evaluated using a specific measurement system, constituted of the Visual Analogue Scale, The Fibromyalgia Impact Questionnaire and The Medical Outcomes Study Sleep Scale. The primary outcome measures assess whether acupuncture can bring about a decrease in pain and an improvement in the quality of life of people suffering from chronic widespread pain; the secondary outcomes assess whether the use of acupuncture leads to improved sleep quality. The results obtained will be analysed at 1st, 4th and 8th weeks from the start of treatment.

Discussion: This technique is aimed to restore some of the imbalances suffered by patients affected with CWP and to improve their symptomatology. We expect to observe a significant improvement in the pain, quality of life and sleep quality of people affected with CWP. The study will be conducted according to the STRICTA guidelines, which lay down the right way to proceed when carrying out scientific studies in the field of acupuncture.

Conditions

• Chronic Widespread Pain

Interventions

DEVICE

Acupuncture

The needles used for the treatments will be single-use needles of two different gauge sizes. One size or the other will be used depending on the area to be treated and the physical condition of the patient. The needles and gauge sizes used in the study are as follows: Dong Bang siliconized needle 0.25 mm x 40 mm Dong Bang siliconized needle 0.20 mm x 30 mm The therapist will assess the patient's condition according to traditional Chinese medicine and will look at the relationship between the patient's most affected areas and the paths of the acupuncture meridians. Subsequently, the combination of Yuan and Luo points to be treated will be determined. This procedure will be followed before every acupuncture session, in such a way that the combination of the points used will depend on the evolution of the symptoms.

DEVICE

Sham Acupuncture

It will follow the validated technique of sham acupuncture with the Park device, without needle penetration in the patient's body. The Park device for the performance of sham acupuncture consists of two plastic tubes, one sliding within the other, and inside which the needle created for the device slides. The longest tube is attached to a circular base, which has an adhesive surface that sticks to the skin so that the device and the needle cannot fall. Blunt ended needles will be used for this technique and thus the needle does not get to pass through the skin but produces a cutaneous stimulation similar to conventional acupuncture needles. These needles are supplied with the kit that contains the Park sham acupuncture device and are registered in the European Union as CE 0120.

Sponsors & Collaborators

• Universitat de Girona

  lead OTHER

Principal Investigators

• Jordi Casado Borrull, Director

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2017-05-31

Completion

2017-05-31

Countries

• Spain

Study Locations