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

NCT03081091 | Unknown

• 1 other identifier: EUSESTE-CT-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Pain will be assessed using the Visual Analogue Scale (VAS).

  The VAS consisted of a 10 mm line with the endpoints 'no pain' and 'worst pain imaginable' .

  up to 8 weeks

• The Fibromyalgia Impact Questionnaire (FIQ) will be used to analyze the quality of life.

  up to 8 weeks

Secondary Outcomes (1)

• The Medical Outcomes Study Sleep Scale (MOS-SS) will be used to assess the sleep quality.

  up to 8 weeks

Study Arms (2)

Intervention group (A) Acupuncture

ACTIVE COMPARATOR

The treatments performed will be personalized and the treatment criteria will be based on the use of the Yuan and Luo points. In clinical practice, the Yuan (source) points and the Luo (connecting) points can be used jointly, linking the two associated meridians (external-internal) in such a way that, after assessing the state of a meridian's path, its Yuan point will be combined with the Luo point of its coupled meridian and vice versa; all this depending on the condition of the muscle fibres and on the path that wants to be treated for these.

Device: Acupuncture

Control group (C) Sham Acupuncture:

SHAM COMPARATOR

The course of action with the patient from the group that will use sham acupuncture will be the same as in the group that receives real treatment: patient in supine position, cleaning of the treated area, use of eye mask during the treatments and selection of points following the previously described Yuan and Luo points' criteria, based on traditional Chinese medicine. The difference of sham acupuncture will lie on the way of performing the acupuncture technique. It will follow the validated technique of sham acupuncture with the Park device, without needle penetration in the patient's body.

Device: Sham Acupuncture

Interventions

Acupuncture DEVICE

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.

Intervention group (A) Acupuncture

Sham Acupuncture DEVICE

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.

Control group (C) Sham Acupuncture:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the criteria set by the American College of Rheumatology for the diagnosis of chronic widespread pain.
• Accepting to sign the informed consent of participation in the study.
• Being older than 18 years.

You may not qualify if:

• Suffering from malignant diseases or active rheumatologic disorders (osteoporosis, rheumatoid arthritis, lupus erythematosus, etc.).
• Suffering from coxarthrosis or severe gonarthrosis.
• Having previously received acupuncture treatments.

Sponsors & Collaborators

• Universitat de Girona: lead

Study Sites (1)

EUSESTE Escola Universitaria de la Salut i l'Esport Terres del'Ebre

Tortosa, Tarragona, 43500, Spain

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Jordi Casado Borrull, Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi Casado Borrull, Director

CONTACT

0034639732682; jordi.casado@euseste.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to the intervention. They will be provided with eye masks so that they cannot see which needles are used in their intervention. Moreover, the same type of equipment will be used with all the participants (although the guide tube to insert the needle is not necessary in true acupuncture). Given the fact that the person who carries out the intervention is different than the one assessing its effects and the latter does not know which group the evaluated subjects belong to, as well as the fact that the person responsible for the statistics is a third person who ignores which of the two groups has received true acupuncture, this is a triple-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: March 15, 2017
• Study Start: January 1, 2017
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: March 15, 2017

Record last verified: 2017-03

Locations

ES (1)