Advertisement

Topics

A Pilot Study on the Use of Nociceptive Flexion Reflex for Fibromyalgia

2014-08-27 03:19:49 | BioPortfolio

Summary

The investigators are doing this study to better understand the role of the central nervous system in processing painful stimuli in patients with fibromyalgia. Specifically, the investigators would like to know whether the central nervous system processing of painful stimuli changes with time and with talk therapy. In addition, the investigators are investigating how changes in your fibromyalgia symptoms may affect certain markers or proteins in your blood.

Description

Overall Design

Female patients with FM will be enrolled in this 12-week prospective cohort study. To effect change in patient's symptoms, subjects (n=30) will be randomized to receive six sessions of phone-based cognitive behavioral therapy (CBT) or to 'usual' care. CBT will be provided from week 1 (baseline) to week 6. Outcome assessments (i.e., self-report symptom questionnaires, plasma neuropeptide levels and NFR) will be performed at baseline, week 6 and week 12. Subjects who not complete all three testing phases of the study will be reported as withdraws, and will be replaced as needed until a total of 30 volunteers have completed this study:

Volunteers will be asked to visit the Fibromyalgia Clinical Research Center on 3 different occasions: baseline (Screening), week 6, and week 12.

During the first visit subjects will be randomly assigned to one of two groups. Similar to flipping a coin, you have a 50% chance of being assigned to either one of two groups: a) telephone-based educational instruction group or b) usual care group. Subjects who are randomly assigned to educational instruction group will receive one phone call per week for the first six weeks of the study. During the phone conversation, you will receive instructions in managing your pain. If subjects are assigned to the educational instruction group, subjects must agree to allow us to audiotape the telephone conversation. Audio-taping the telephone conversations will help us give you the highest quality of instruction. On the other hand, subjects assigned to the usual care group will receive no telephone calls from the research team.

During each visit subjects will be asked to do the following:

1. Complete a comprehensive questionnaire (computer-based or the traditional paper and pen format) in regard to how fibromyalgia affects your daily living.

Risks: You may feel uncomfortable or care not to answer a particular question. To minimize these risks, you can tell the researcher that you feel uncomfortable or do not wish to answer the question.

2. Provide a blood sample (10 ml).The purpose or this blood test is to examine changes in certain blood markers in relation to your changes in your symptoms

Risks: The physical risks associated with participation in this study are with the blood draw. The process of drawing blood may cause bleeding, bruising, pain, lightheadedness, and some minor swelling around the area of the needle stick. Occasionally an infection or bleeding may develop where the needle was placed in the vein. To minimize these risks, the blood specimen will be obtained by experienced technicians.

3. Undergo nociceptive flexion reflex (NFR) testing. This test examines how your body responds to painful stimuli. To begin each testing session, electrodes used to measure the nociceptive flexion reflex will be attached to your left leg. To measure the reflex, we will administer a series of electrical stimuli to the ankle of your left foot. After each stimulus you will be asked to rate the stimulus intensity using a scale with anchors of 0 (no sensation), 50 (pain threshold), and 100 (maximum tolerable). This procedure is used to determine the intensity of stimulus required to elicit a nociceptive flexion reflex response from your left hamstring muscle. This reflex is so small that you may not even notice any activity in your leg muscles. The intensity of electrical stimuli will be increased slowly until a reflex response is shown, but the intensity will NEVER exceed that which you rate as a "100" (maximum tolerable). At the higher intensities, the electrical stimulus is described by others as feeling like a "brief pinprick" or "carpet shock".

We will use the same procedure to assess your pain tolerance threshold for electrical stimulation to your ankle. Stimulus intensity will be increased slowly and you will be asked to rate each stimulus on the 0-100 scale. The procedure will end as soon as you provide a stimulus intensity rating of "100" (maximum tolerable).

Risks: The nociceptive flexion reflex procedure is likely to elicit temporary discomfort, increases in heart rate and blood pressure as well as sensations of discomfort or pain. Further, preparation of the skin required to apply electrodes may be mildly irritating or uncomfortable, and may leave behind some redness of the skin that could require a few days to heal. To minimize these risks, only well trained technicians will conduct this test. It is important to note that this test is similar to an EMG (electromyogram) study - a test commonly done in routine medical care.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Conditions

Fibromyalgia

Intervention

Cognitive Behavioral Therapy

Location

National Institute of Fitness and Sport; IUPUI Campus
Indianapolis
Indiana
United States
46202

Status

Completed

Source

Indiana University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:49-0400

Clinical Trials [2447 Associated Clinical Trials listed on BioPortfolio]

Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk

The present study is a new approach of examining tailored cognitive-behavioral interventions for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with re...

Multicomponent Therapy for Fibromyalgia

Therapy for fibromyalgia is a well discussed topic in literature, yet not thoroughly evidence-based. Several unicomponent therapies seem to be benificial. Whereas multicomponent and multid...

Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia

Fibromyalgia (FM) is a common and chronic disorder characterized by widespread muscle pain, fatigue, and multiple tender points. The majority of individuals with FM report sleep problems, ...

Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia

This study evaluates whether Fibromyalgia Integrative Training program for Teens (FIT Teens), a combined cognitive behavioral therapy and neuromuscular exercise training program is more ef...

Fibromyalgia: Interventions for Pain and Mood Regulation

This study compares the impact of cognitive-behavioral therapy for pain (CBT-P), mindful awareness and acceptance treatment (M), and arthritis education as an active control condition (E) ...

PubMed Articles [14482 Associated PubMed Articles listed on BioPortfolio]

Cognitive behavioral treatments for insomnia (CBT-I) and pain (CBT-P) in adults with comorbid chronic insomnia and fibromyalgia: Clinical outcomes from the SPIN randomized controlled trial.

To examine the effects of cognitive behavioral treatments for insomnia (CBT-I) and pain (CBT-P) in patients with comorbid fibromyalgia and insomnia.

Applicability Evaluation of Simplified Cognitive Behavioral Therapy.

We have developed a structured cognitive behavioral therapy manual for anxiety disorder in China, and the present study evaluated the applicability of simplified cognitive behavioral therapy based on ...

Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia.

The aim of this study was to investigate in a randomized clinical trial the role of sleep-related cognitive variables in the long-term efficacy of an online, fully automated cognitive behavioral thera...

The effect of depressive symptoms on cognition in patients with fibromyalgia.

Fibromyalgia (FM) patients frequently complain of cognitive problems, but it remains unclear whether these cognitive complaints can be attributed to a dysfunction of the central nervous system or if t...

Occupational Therapist-Delivered Cognitive-Behavioral Therapy for Knee Osteoarthritis: A Randomized Pilot Study.

This study assessed the feasibility and preliminary efficacy of an online-assisted, occupational therapist-delivered, cognitive-behavioral therapy intervention to promote physical function in patients...

Medical and Biotech [MESH] Definitions

A direct form of psychotherapy based on the interpretation of situations (cognitive structure of experiences) that determine how an individual feels and behaves. It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and verbal techniques to identify and correct negative thinking that is at the root of the aberrant behavior.

Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations.

The use of art as an adjunctive therapy in the treatment of neurological, mental, or behavioral disorders.

A common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, HEADACHES, and occasionally DEPRESSION. There is significant overlap between fibromyalgia and the chronic fatigue syndrome (FATIGUE SYNDROME, CHRONIC). Fibromyalgia may arise as a primary or secondary disease process. It is most frequent in females aged 20 to 50 years. (From Adams et al., Principles of Neurology, 6th ed, p1494-95)

Therapy whose primary emphasis is on the physical and social structuring of the environment to promote interpersonal relationships which will be influential in reducing behavioral disturbances of patients.

More From BioPortfolio on "A Pilot Study on the Use of Nociceptive Flexion Reflex for Fibromyalgia"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Rheumatology
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...

Fibromyalgia
FMS (fibromyalgia syndrome) is a widespread idiopathic musculoskeletal pain and fatigue disorder, which is chronic. The pain comes from connective tissues, such as muscles, tendons, and ligaments, but not joints and patients describe it as an ache all ov...


Searches Linking to this Trial