The addition of upper cervical manipulative therapy in the treatment of patients with fibromyalgia: A randomized controlled trial

Completed

• Conditions: fibromyalgia; Physical Medicine / Rehabilitation - Physiotherapy; Musculoskeletal - Other muscular and skeletal disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12615000006549
• Lead Sponsor: Ibrahim Moustafa Moustafa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients were enrolled, if they fulfilled the American College of Rheumatology criteria for fibromyalgia syndrome, experienced symptoms for at least 48 months with no recent remission of symptoms to any degree, reported a score >4 on the pain intensity, age 40–65 years, reported a score greater than or equal to 59 on the Fibromyalgia Impact Questionnaire severe fibromyalgia” , and able to read and comprehend English.

Further , the patients were included if they had a limited C1-C2 ROM using the flexion-rotation test.The flexion-rotation test has been found to possess high diagnostic validity for determining the presence of C1-2 joint dysfunction, Ogince et al reporting sensitivity and specificity of 91% and 90%, respectively. For asymptomatic subjects, mean unilateral ROM during the flexion rotation test, to the left or right, has been found to be 39 degree to 45 degree; whereas subjects with C1-2 joint dysfunction have been found to possess only 22 degree to 26 degree of unilateral ROM towards the most restricted side during the flexion rotation test.

Exclusion Criteria

Exclusion criteria included rheumatoid disease, unstable hypertension, severe cardiopulmonary problems, chronic viral infection, and history of any significant medical conditions such as hepatitis, herpes, lupus, multiple sclerosis, rheumatoid arthritis, polio, epilepsy, rheumatic fever, cancer, history of neck or back surgeries, or any psychiatric disorder affecting participant compliance.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure for determining the treatment effect was Fibromyalgia Impact Questionnaire, which is a valid self-administered questionnaire developed to measure fibromyalgia participant status, progress, and outcomes. The Fibromyalgia Impact Questionnaire is composed of 10 subscales of disabilities and symptoms (physical function, work missed day, job ability, feel good, pain, fatigue, sleep, stiffness, anxiety and depression).The total scores range from 0 to 100, higher the Fibromyalgia Impact Questionnaire score, the greater is the impact of fibromyalgia on the participant <br>[three time intervals: baseline, 12 weeks, and 1 year after the 12 week follow up.]