Overview

This trial is active, not recruiting.

Condition fibromyalgia
Treatments manipulative and massage therapy, exercise program
Sponsor Universidad de Almeria
Start date August 2016
End date May 2017
Trial size 64 participants
Trial identifier NCT02864524, UAL-499

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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):
manipulative and massage therapy
(Active Comparator)
Ten sessions (2 time/ week): Initial heating and continuing with aerobic and muscle stretching exercises.
exercise program

Primary Outcomes

Measure
Pain Intensity
time frame: Changes from Baseline, and 5 weeks

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Effects of Manipulative Therapy in the Lower Thoracic and Cervical Spine in Subjects With Fibromyalgia Syndrome
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Universidad de Almeria.