Back to resultsManipulative and Massage Therapy in the Lower Thoracic and Cervical Spine in Subjects With Fibromyalgia Syndrome
Primary Purpose
Fibromyalgia
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manipulative and Massage Therapy
Exercise Program
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Physical Therapy Modalities, Exercises, Musculoskeletal Manipulations
Eligibility Criteria
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.
Sites / Locations
- Adelaida María Castro-Sánchez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Manipulative and Massage Therapy
Exercise Program
Arm Description
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):
Ten sessions (2 time/ week): Initial heating and continuing with aerobic and muscle stretching exercises.
Outcomes
Primary Outcome Measures
Pain Intensity
A 10-point numerical scale (0 = no pain, 10: very severe pain)
Secondary Outcome Measures
McGill Pain Questionnaire
Pittsburgh Quality of Life Questionnaire
Quality of Life Questionnaire (SF-36)
Fibromyalgia Impact Questionnaire (FIQ)
Hospital Anxiety and Depression Scale (HADS)
Beck Depression Inventory
Fatigue Impact Scale (FIS)
Schöber Test
Pressure Algometry
Full Information
NCT ID
NCT02864524
First Posted
August 9, 2016
Last Updated
November 11, 2020
Sponsor
Universidad de Almeria
1. Study Identification
Unique Protocol Identification Number
NCT02864524
Brief Title
Manipulative and Massage Therapy in the Lower Thoracic and Cervical Spine in Subjects With Fibromyalgia Syndrome
Official Title
Effects of Manipulative Therapy in the Lower Thoracic and Cervical Spine in Subjects With Fibromyalgia Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
November 2020 (Actual)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Physical Therapy Modalities, Exercises, Musculoskeletal Manipulations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Manipulative and Massage Therapy
Arm Type
Experimental
Arm Description
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):
Arm Title
Exercise Program
Arm Type
Active Comparator
Arm Description
Ten sessions (2 time/ week): Initial heating and continuing with aerobic and muscle stretching exercises.
Intervention Type
Other
Intervention Name(s)
Manipulative and Massage Therapy
Intervention Type
Other
Intervention Name(s)
Exercise Program
Primary Outcome Measure Information:
Title
Pain Intensity
Description
A 10-point numerical scale (0 = no pain, 10: very severe pain)
Time Frame
Changes from Baseline, and 5 weeks
Secondary Outcome Measure Information:
Title
McGill Pain Questionnaire
Time Frame
Changes from Baseline, and 5 weeks
Title
Pittsburgh Quality of Life Questionnaire
Time Frame
Changes from Baseline, and 5 weeks
Title
Quality of Life Questionnaire (SF-36)
Time Frame
Changes from Baseline, and 5 weeks
Title
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame
Changes from Baseline, and 5 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
Changes from Baseline, and 5 weeks
Title
Beck Depression Inventory
Time Frame
Changes from Baseline, and 5 weeks
Title
Fatigue Impact Scale (FIS)
Time Frame
Changes from Baseline, and 5 weeks
Title
Schöber Test
Time Frame
Changes from Baseline, and 5 weeks
Title
Pressure Algometry
Time Frame
Changes from Baseline, and 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Adelaida María Castro-Sánchez
City
Almeria
ZIP/Postal Code
04120
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27473164
Citation
Ericsson A, Palstam A, Larsson A, Lofgren M, Bileviciute-Ljungar I, Bjersing J, Gerdle B, Kosek E, Mannerkorpi K. Resistance exercise improves physical fatigue in women with fibromyalgia: a randomized controlled trial. Arthritis Res Ther. 2016 Jul 30;18:176. doi: 10.1186/s13075-016-1073-3.
Results Reference
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PubMed Identifier
27457628
Citation
Perez de la Cruz S, Lambeck J. A new approach towards improved quality of life in fibromyalgia: a pilot study on the effects of an aquatic Ai Chi program. Int J Rheum Dis. 2018 Aug;21(8):1525-1532. doi: 10.1111/1756-185X.12930. Epub 2016 Jul 26.
Results Reference
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PubMed Identifier
27377815
Citation
Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Hauser W, Fluss E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4.
Results Reference
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PubMed Identifier
27312858
Citation
Jones KD. Promoting physical activity in fibromyalgia. Pain Manag. 2016 May;6(4):321-4. doi: 10.2217/pmt-2016-0018. Epub 2016 Jun 17. No abstract available.
Results Reference
background
PubMed Identifier
27306300
Citation
Okifuji A, Gao J, Bokat C, Hare BD. Management of fibromyalgia syndrome in 2016. Pain Manag. 2016 May;6(4):383-400. doi: 10.2217/pmt-2016-0006. Epub 2016 Jun 16.
Results Reference
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PubMed Identifier
27297077
Citation
Ericsson A, Mannerkorpi K. How to manage fatigue in fibromyalgia: nonpharmacological options. Pain Manag. 2016 May;6(4):331-8. doi: 10.2217/pmt-2016-0015. Epub 2016 Jun 14.
Results Reference
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PubMed Identifier
27296860
Citation
Ernberg M, Christidis N, Ghafouri B, Bileviciute-Ljungar I, Lofgren M, Larsson A, Palstam A, Bjersing J, Mannerkorpi K, Kosek E, Gerdle B. Effects of 15 weeks of resistance exercise on pro-inflammatory cytokine levels in the vastus lateralis muscle of patients with fibromyalgia. Arthritis Res Ther. 2016 Jun 13;18(1):137. doi: 10.1186/s13075-016-1041-y.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Moustafa IM, Diab AA. The addition of upper cervical manipulative therapy in the treatment of patients with fibromyalgia: a randomized controlled trial. Rheumatol Int. 2015 Jul;35(7):1163-74. doi: 10.1007/s00296-015-3248-7. Epub 2015 Mar 18.
Results Reference
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PubMed Identifier
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Citation
Yuan SL, Matsutani LA, Marques AP. Effectiveness of different styles of massage therapy in fibromyalgia: a systematic review and meta-analysis. Man Ther. 2015 Apr;20(2):257-64. doi: 10.1016/j.math.2014.09.003. Epub 2014 Oct 5.
Results Reference
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Citation
Li YH, Wang FY, Feng CQ, Yang XF, Sun YH. Massage therapy for fibromyalgia: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014 Feb 20;9(2):e89304. doi: 10.1371/journal.pone.0089304. eCollection 2014.
Results Reference
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Manipulative and Massage Therapy in the Lower Thoracic and Cervical Spine in Subjects With Fibromyalgia Syndrome
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