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Completed

NCT Number: NCT06194942

THE EFFECT OF CHIROPRACTIC THORACIC MANIPULATION ON PAIN, DEPRESSION, SLEEP AND QUALITY OF LIFE IN PATIENTS WITH FIBROMYALGIA

This study aimed to investigate the effects of thoracic chiropractic manipulations on pain intensity, depression levels, sleep, and quality of life in women diagnosed with fibromyalgia. The research included 50 female participants aged 25-45 who had been diagnosed with fibromyalgia between 2022 and 2023 at Şişli Hamidiye Etfal Education and Research Hospital. The participants were randomly divided into two groups: a chiropractic treatment group and a control group. Both groups completed pre-treatment assessments using the Visual Analog Scale (VAS), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), and Short Form 36 (SF-36). The chiropractic treatment group received thoracic chiropractic manipulations (HVLA) twice a week for a total of six sessions over three weeks, while the control group received sham manipulations. A week after the final session, all participants completed the assessments again.

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Key information

Conditions

Fibromyalgia Behavior Behavioral Symptoms Depression Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Sarıyer, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Having been diagnosed with fibromyalgia by a doctor.
  • Having good cognitive status.
  • Willingness to participate in the study voluntarily.
  • Being a female aged between 25 and 45.
  • The symptoms persisting without any degree of improvement or decrease recently.
  • Having dysfunction (limited movement) in the thoracic region.
  • Having no condition that would prevent high-velocity low-amplitude (HVLA) manipulation.

Exclusion criteria

  • Receiving any non-pharmacological treatment.
  • Having heart, kidney, or liver failure.
  • Having inflammatory, psychiatric, neurological, and/or chronic progressive systemic diseases.
  • Pregnancy.
  • Having a history of acute or past fractures.
  • Malignancy history.
  • Having a history of thoracic surgery.
  • Having thoracic hernias, radiculopathy, motor deficits spondylosis, spondylolisthesis, narrow canal, extruded hernia, disc herniation, discitis diagnoses.
  • Metabolic bone diseases.
  • Infection, fever, hypotension, respiratory disorders limiting treatment application.
  • Having a rheumatic disease (except osteoarthritis).
  • Osteoporosis.

Treatment and study plan

Chiropractic Manipulation

Other

Chiropractic manipulation is a manual therapy technique commonly used by chiropractors. It involves the application of controlled, sudden force to a specific joint, often with the goal of improving joint function, reducing pain, and promoting overall musculoskeletal health.In the context of thoracic chiropractic manipulation, the chiropractor focuses on the vertebrae and joints in the thoracic spine.

Sham Manipulation

Other

Sham manipulation refers to a simulated or placebo form of a manual therapy intervention, often used in research studies, especially in clinical trials involving chiropractic or physical therapy. the term "sham manipulation" likely implies a procedure that mimics the physical aspects of a real chiropractic manipulation but does not involve the actual therapeutic forces or movements.

The chiropractic treatment group received thoracic chiropractic manipulations (HVLA) twice a week for a total of six sessions over three weeks, while the control group received sham manipulations.

Primary outcomes

  1. VİSUAL PAİN SCALE

    Time frame: before the treatment and one week after the treatment.

    he "Visual Pain Scale" is a method used to assess and quantify pain intensity through a visual representation. It typically consists of a line or numerical scale accompanied by descriptive labels or facial expressions that reflect different levels of pain severity. Participants are asked to point to or select the position on the scale that best corresponds to their perceived level of pain.

Secondary outcomes

  1. Beck Depression Inventory (BDI)

    Time frame: before the treatment and one week after the treatment.

    The Beck Depression Inventory (BDI) is a self-report questionnaire designed to assess the severity of depression symptoms in individuals.The inventory consists of 21 multiple-choice questions, each corresponding to a specific symptom of depression. Individuals are asked to select the statement that best describes their feelings over the past two weeks, including the day of the assessment. The responses are scored on a scale ranging from 0 to 3, with higher scores indicating more severe depressive symptoms. The total score can be interpreted to assess the overall level of depression, typically categorized as minimal (0-13), mild (14-19), moderate (20-28), or severe (29-63).

  2. Pittsburgh Sleep Quality Index

    Time frame: before the treatment and one week after the treatment.

    The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire comprising 19 items, grouped into seven components, to assess various aspects of sleep quality and disturbances. Higher scores indicating poorer sleep quality.

  3. Short Form-36

    Time frame: before the treatment and one week after the treatment.

    The Short Form 36 (SF-36) is a widely used questionnaire designed to assess an individual's health-related quality of life. It consists of 36 items covering eight health domains, including physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.

Sponsors and collaborators

Lead sponsor

Bahçeşehir University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2024
Registry last updated
Oct 9, 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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