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Completed

NCT Number: NCT06408675

Loss of Cervical Lordosis in 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital, Ankara, Çankaya, Turkey (Türkiye)

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Visual analogue scale (VAS)

    Time frame: day 1,

    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

Secondary outcomes

  1. Quality of Life Scale-Short Form (SF-36)

    Time frame: day 1.

    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

  2. Neck disability index (NDI)

    Time frame: day 1

    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)

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Loss of Cervical Lordosis an Association of Fibromyalgia Syndrome

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 10, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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