Clinical trial NCT02864524: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: Physical Therapy Modalities
Exercises
Musculoskeletal Manipulations
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pain Intensity
timeFrame: Changes from Baseline, and 5 weeks
Secondary outcomes:
measure: McGill Pain Questionnaire
timeFrame: Changes from Baseline, and 5 weeks
measure: Pittsburgh Quality of Life Questionnaire
timeFrame: Changes from Baseline, and 5 weeks
measure: Quality of Life Questionnaire (SF-36)
timeFrame: Changes from Baseline, and 5 weeks
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Changes from Baseline, and 5 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Changes from Baseline, and 5 weeks
measure: Beck Depression Inventory
timeFrame: Changes from Baseline, and 5 weeks
measure: Fatigue Impact Scale (FIS)
timeFrame: Changes from Baseline, and 5 weeks
measure: Schöber Test
timeFrame: Changes from Baseline, and 5 weeks
measure: Pressure Algometry
timeFrame: Changes from Baseline, and 5 weeks
Other outcomes:
Locations:
city: Almeria
country: Spain
facility: Adelaida María Castro-Sánchez
Study officials:
References:
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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.
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.
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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.
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.
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.
citation: Bervoets DC, Luijsterburg PA, Alessie JJ, Buijs MJ, Verhagen AP. Massage therapy has short-term benefits for people with common musculoskeletal disorders compared to no treatment: a systematic review. J Physiother. 2015 Jul;61(3):106-16. doi: 10.1016/j.jphys.2015.05.018. Epub 2015 Jun 17.
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.
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.
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.