Treatment and Assessment of Fibromyalgia

Summary

Fibromyalgia is a common disorder affecting approximately 2% of the Canadian population. Patients diagnosed with fibromyalgia commonly present with chronic, widespread pain as well as fatigue, depression, mood disturbances, and cognitive symptoms. As a result, fibromyalgia has a negative impact on the patient's quality of life, and a negative financial impact for them, society, and the healthcare system, through lost wages and delayed diagnosis. Therefore a more direct and conclusive method of diagnosis is needed.

Recently, fibromyalgia diagnosis has been based on the modified American College of Rheumatology Preliminary Diagnostic Criteria for fibromyalgia. To assist with diagnosis, recent evidence shows that compared to healthy people, people with fibromyalgia present with differences on functional MRI (fMRI) whole brain scans, as well as differences in a functional blood biomarker challenge test, known as fm/a. The fm/a determines the function of the immune system in response to a stimulus, and has been used previously to show that people with fibromyalgia have a severely blunted immune response.

Despite the number of treatment options available, interventions for chronic pain remain largely ineffective. In light of its demonstrated effectiveness, safety, and ease of use in previous studies, radial shockwave therapy (RSWT) has been selected for inclusion in the present study. The main objective of this study is to determine the efficacy and effect of RSWT compared to placebo on the symptoms frequently reported in association with fibromyalgia. In addition, the fm/a and brain activity associated with pain patterns (fMRI) may assist in early diagnosis and prediction of treatment success in patients with fibromyalgia.

Conditions

• Fibromyalgia

Interventions

DEVICE

Radial Shockwave Therapy

5 treatments in total scheduled weekly; RSWT to the painful areas will be undertaken with 500 shocks (1.5 bar, 15 Hz), then 1000 shocks (2 bar, 8 Hz), and finally 500 shocks (1.5 bar, 15 Hz) to the most painful spot within each of the 3 most painful regions as described by the participant.

OTHER

Placebo Comparator: Group 2 - Placebo Group

5 treatments in total scheduled weekly; placebo to the painful areas will be undertaken with 2000 shocks to the most painful spot within each of the 3 most painful regions as described by the participant.

Sponsors & Collaborators

• Lakehead University

  lead OTHER

Principal Investigators

• Paolo Sanzo, DScPT · Lakehead University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-01

Primary Completion

2018-12-31

Completion

2018-12-31

Countries

• Canada

Study Locations