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

Not Applicable

• Conditions: Fibromyalgia
• Interventions: Other: Manipulative and Massage Therapy; Other: Exercise Program

• Registration Number: NCT02864524
• Lead Sponsor: Universidad de Almeria

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-12
• Status Verified: 2020-11
• Primary Completion: 2020-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manipulative and Massage Therapy	Manipulative and Massage Therapy	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):
Exercise Program	Exercise Program	Ten sessions (2 time/ week): Initial heating and continuing with aerobic and muscle stretching exercises.

Primary Outcome Measures

Name	Time	Method
Pain Intensity	Changes from Baseline, and 5 weeks	A 10-point numerical scale (0 = no pain, 10: very severe pain)

Secondary Outcome Measures

Name	Time	Method
Schöber Test	Changes from Baseline, and 5 weeks
Pittsburgh Quality of Life Questionnaire	Changes from Baseline, and 5 weeks
McGill Pain 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
Fatigue Impact Scale (FIS)	Changes from Baseline, and 5 weeks
Beck Depression Inventory	Changes from Baseline, and 5 weeks
Pressure Algometry	Changes from Baseline, and 5 weeks
Hospital Anxiety and Depression Scale (HADS)	Changes from Baseline, and 5 weeks

Trial Locations

Locations (1)

Adelaida María Castro-Sánchez; 🇪🇸 Almeria, Spain