Loss of Cervical Lordosis in Fibromyalgia Syndrome

Loss of Cervical Lordosis an Association of Fibromyalgia Syndrome

Purpose: The causes of chronic and widespread pain in fibromyalgia (FMS) have not been eluciated yet. Previous reports determined that posture control changed, muscle strength decreased, body posture misaligned (maladaptive posture), and functional capacity decreased in FMS patients. The aim of this study was to investigate the relationship between loss of cervical lordosis, pain, quality of life (QOL) and neck disability in patients with FMS.

Methods: A total of 107 FMS (88 females and 20 males; range of age:18-65) were included to the study. Patients were divided into two groups according to the angle of cervical lordosis measured by the Cobb method, group 1 with a Cobb angle of ≤10°, and group 2 with an angle greater than >10°. Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia, Cervical Lordosis
• Intervention / Treatment: Other: Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.

• Study Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06800
      • Ankara City Hospital
    • Ankara, Çankaya, Turkey, 06800
      • Emine Esra Bilir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

A total of 107 patients who applied to the physical therapy and rehabilitation outpatient clinic; . Age range between 18-65 , male-female, Patients diagnosed with fibromyalgia according to the American College of Rheumatology 1990 criteria

Description

Inclusion Criteria:

Age range between 18 and 65

-Patients diagnosed with fibromyalgia according to the American College of Rheumatology 1990 criteria

Exclusion Criteria:

Patients diagnosed with known systemic (e.g., inflammatory rheumatic diseases, diabetes mellitus and systemic arterial hypertension), metabolic or endocrine diseasesas well as tumoral, neurologic or infectious diseases,

• Patients with a history of trauma and surgery affecting the neck area,
• Patients who received trigger point injection therapy for neck pain within the last 6 months,
• Patients with cervical disc herniation or myelopathy, spondylolisthesis, spondylolysis, cervicothoracic kyphoscoliosis,
• Patients who had been receiving therapy for any psychiatric diagnosis for the last 3 months and antidepressant drug use,
• Patients with history of neuropathic diseases,
• Patients with a condition affecting neck muscles, such as dystonia,
• Inflammatory muscle disease and myopathy
• Pregnant patients were not included to the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group 1 with a Cobb angle of ≤10°; cervical lordosis cobb angele ≤10°	Other: Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.; Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.
group 2 with an angle greater than >10°; cervical lordosis cobb angele >10°	Other: Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.; Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale (VAS)	VAS scale used to measure the severity of pain (0-10 cm). According to this scale, the value 0 means no pain and the value 10 means very severe pain	day 1,

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Scale-Short Form (SF-36)	This scale assesses many aspects of health and consists of 36 questions with 8 subtitles. The assessment is performed considering the last 4 weeks of the patient and the scale is assessed between 0 point and 100 points in which score 100 shows good health state, the score 0 shows poor health state	day 1.
Neck disability index (NDI)	This form has a total of 10 items, which includes pain severity, personal care, lifting, reading, headache, concentration, work status, driving, sleep and recreation. Scoring for each question ranges from 0 to 5 (0: the best health state and 5: the worst health state). High scores in patients mean serious disability. Total point were scored between 0 (no disability) and 100 (complete disability)	day 1

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Fibromyalgia, cervical lordosis
• Additional Relevant MeSH Terms: Nervous System Diseases; Nutrition Disorders; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Deficiency Diseases; Malnutrition; Spinal Diseases; Bone Diseases; Spinal Curvatures; Fibromyalgia; Myofascial Pain Syndromes; Lordosis; Swayback
• Other Study ID Numbers: B.10.1.TKH.4.34.H.GP.0.01/146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No