The aim of this study is to evaluate whether spinal manipulation, which is a potential treatment method for musculoskeletal pain, has an additional contribution in patients with fibromyalgia receiving standard pharmacological treatment.
Although fibromyalgia (FM) is quite common, success rates in conservative treatment are unsatisfying. Combination of pharmacological and non-pharmacological applications is recommended in treatment. Although the etiology of FM is not well known, characteristic findings such as hyperalgesia and allodynia suggest problems related to pain and sensorial processing in the central nervous system. It has been suggested that spinal manipulation can alter sensorimotor integration in the central nervous system and therefore can be used in the treatment of central sensitization syndromes. However, manual therapy applications, which were examined under the heading of chiropractic in the 2016 EULAR treatment recommendations, were not recommended due to the low quality (open-label, quasi-experimental) of the studies conducted so far. However, it has been suggested for future studies to investigate whether the combined use of pharmacological and non-pharmacological treatments is more effective than single modality management. But since then unfortunately a high level of evidence also could not be obtained related to use of spinal manipulation in FM due to reasons such as lack of reporting of the manual therapy methods used in detail, conducting studies involving mostly soft tissue techniques and not following CONSORT recommendations. This study is planned as a prospective, triple-blinding, randomized controlled and 3-arm parallel group design clinical study considering the concepts that have been lacking the literature.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Intervention will be administered twice a week for 3 weeks. Each treatment session will be given in 20-minute sessions consisting of 10 minutes of manual examination and 10 minutes of manual treatment.
The practitioner will primarily identify the areas where somatic dysfunction is detected and keep the application away from these areas. The patient will be positioned for treatment as in active therapy, but once in the lock position, a lower thrust will be given by releasing some back from the position.
Bezmialem Vakif University Hospital
Istanbul, Turkey (Türkiye)
Change from Baseline Pain Intensity at 1 and 3 months
Patients will be asked to mark their pain on the visual analog scale (VAS) during each visits.
Time frame: Baseline, one week after the last treatment session (1st month) and 3rd month
Change from Baseline Tenderness (tender point pain threshold score) at 1 and 3 months
Pressure pain threshold of 18 points specified in 1990 American Collage of Rheumatology (ACR) Fibromyalgia classification criteria will be evaluated with The Lafayette Manual Muscle Tester Model 01165 (Lafayette Instrument Company, Lafayette IN, USA). This device is a dynamometer. It has been shown that if circumference is used instead of area as the correction coefficient hand dynamometers with wider tips than standard algometers are also valid and reliable in the pressure pain threshold measurement. The Lafayette Hand-Held Dynamometer uses a tip with a circumference of 5.65 cm. The applied force (kg) / 5.65 will be used as the pressure pain threshold unit in the study. The arithmetic mean of the data obtained from 18 points will be recorded as the tender point pain threshold score.
Time frame: Baseline, one week after the last treatment session (1st month) and 3rd month
Change from Baseline Revised Fibromyalgia Impact Questionnaire (FIQR) at 1 and 3 months
FIQR consists of 3 domains. The first domain contains 9 questions that can be scored between 0 and 10 and the score of the physical function is found by dividing the total score by three. Second domain contains 2 questions and the overall impact score is the sum of the scores from these two questions. Third domain consists of 10 questions and symptom score is obtained by dividing the total score by two. Total FIQR score is the sum of 3 domain points.
Time frame: Baseline, one week after the last treatment session (1st month) and 3rd month
Change from Baseline Pain Extent at 1 and 3 months
The extent of the pain will be evaluated by widespread pain index (WPI). The WPI quantifies the extent of bodily pain on a 0-19 scale by asking patients if they have had pain or tenderness in 19 different body regions (shoulder girdle, hip, jaw, upper arm, upper leg, lower arm, and lower leg on each side of the body, as well as upper back, lower back, chest, neck, and abdomen) over the past week, with each painful or tender region scoring 1 point.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, one week after the last treatment session (1st month) and 3rd month
Change from Baseline Fibromyalgia Severity Score (FSS) at 1 and 3 months
FSS is the sum of the WPI and symptom severity scale (SSS) scores. SSS consists of two domains. For the first domain, the complaints of fatigue, waking unrefreshed and cognitive symptoms are scored between 0 (no problem) and 3 (life-disturbing problems ). For the second domain, headaches, pain or cramps in lower abdomen, and depression are scored between 0 (absent) and 1 (present). The total score gives the SSS score.
Time frame: Baseline, one week after the last treatment session (1st month) and 3rd month