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

November 11, 2020 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almeria, Spain, 04120
        • Adelaida María Castro-Sánchez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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):
Other: Manipulative and Massage Therapy
ACTIVE_COMPARATOR: Exercise Program
Ten sessions (2 time/ week): Initial heating and continuing with aerobic and muscle stretching exercises.
Other: Exercise Program

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ACTUAL)

November 1, 2020

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (ESTIMATE)

August 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 11, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAL-499

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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