Manipulative and Massage Therapy in the Lower Thoracic and Cervical Spine in Subjects With Fibromyalgia Syndrome

Study Overview
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Brief Summary
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Objective: Compare degree of improvement can reach patients diagnosed with fibromyalgia syndrome, by treatment with Manipulative and Massage Techniques versus an exercise program for lower thoracic and cervical spine. Study Design: A single-blind randomized controlled trial was conducted on patients with fibromyalgia syndrome (FMS). Setting: Clinical setting. Methods: Sixty-four subjects with FMS were randomly assigned to an experimental group receiving manipulative and massage therapy, or to a control group for exercise program.

Official Title
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Effects of Manipulative Therapy in the Lower Thoracic and Cervical Spine in Subjects With Fibromyalgia Syndrome

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Manipulative and Massage Therapy
* Other: Exercise Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed Fibromyalgia Syndrome. Limitation of usual activities due to pain on at least 1 day in the previous 30 days. Agreement to attend evening therapy sessions. Non-practice of regular physical activity. Exclusion Criteria: A history of surgery. The presence of comorbid conditions (e.g., morbid obesity, inflammatory diseases, irritable bowel syndrome and interstitial cystitis). A history of whiplash injury. Severe physical disability. Uncontrolled endocrine disorders (e.g., hyperthyroidism, diabetes). Illness (e.g., schizophrenia or substance abuse). The use of medication other than as-needed analgesics (excluding long-term narcotics). Malignancy. Psychiatric disorders. A score of ≥ 9 points in the Beck depression inventory.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manipulative and Massage Therapy<br>Ten sessions (2/week): High speed and low amplitude technique to lower cervical spine (C3-C4). Dog technique flexion for high thoracic area (T1-T4). Dog technique flexion for mid-thoracic area (T5-T8). Dog technique flexed to low thoracic (T6-T12). Classic Massage Therapy during 40 minutes (2 time / week): | Other: Manipulative and Massage Therapy<br> <br> |
| Active Comparator: Exercise Program<br>Ten sessions (2 time/ week): Initial heating and continuing with aerobic and muscle stretching exercises. | Other: Exercise Program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | A 10-point numerical scale (0 = no pain, 10: very severe pain) | Changes from Baseline, and 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| McGill Pain Questionnaire |  | Changes from Baseline, and 5 weeks | 
| Pittsburgh Quality of Life Questionnaire |  | Changes from Baseline, and 5 weeks | 
| Quality of Life Questionnaire (SF-36) |  | Changes from Baseline, and 5 weeks | 
| Fibromyalgia Impact Questionnaire (FIQ) |  | Changes from Baseline, and 5 weeks | 
| Hospital Anxiety and Depression Scale (HADS) |  | Changes from Baseline, and 5 weeks | 
| Beck Depression Inventory |  | Changes from Baseline, and 5 weeks | 
| Fatigue Impact Scale (FIS) |  | Changes from Baseline, and 5 weeks | 
| Schöber Test |  | Changes from Baseline, and 5 weeks | 
| Pressure Algometry |  | Changes from Baseline, and 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Therapy Modalities, Exercises, Musculoskeletal Manipulations