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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02864524
• Other study ID #: UAL-499
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: June 2021

Study information

• Verified date: November 2020
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: June 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Manipulative and Massage Therapy

• Exercise Program

Locations

Country	Name	City	State
Spain	Adelaida María Castro-Sánchez	Almeria

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

References & Publications (11)

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. Review. — View 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. — View Citation

Ericsson A, Palstam A, Larsson A, Löfgren 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. — View Citation

Ernberg M, Christidis N, Ghafouri B, Bileviciute-Ljungar I, Löfgren 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. — View 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. — View 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. — View Citation

Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Häuser 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. Review. — View 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. — View 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. Review. — View Citation

Pérez 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. — View 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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	A 10-point numerical scale (0 = no pain, 10: very severe pain)	Changes from Baseline, and 5 weeks
Secondary	McGill Pain Questionnaire		Changes from Baseline, and 5 weeks
Secondary	Pittsburgh Quality of Life Questionnaire		Changes from Baseline, and 5 weeks
Secondary	Quality of Life Questionnaire (SF-36)		Changes from Baseline, and 5 weeks
Secondary	Fibromyalgia Impact Questionnaire (FIQ)		Changes from Baseline, and 5 weeks
Secondary	Hospital Anxiety and Depression Scale (HADS)		Changes from Baseline, and 5 weeks
Secondary	Beck Depression Inventory		Changes from Baseline, and 5 weeks
Secondary	Fatigue Impact Scale (FIS)		Changes from Baseline, and 5 weeks
Secondary	Schöber Test		Changes from Baseline, and 5 weeks
Secondary	Pressure Algometry		Changes from Baseline, and 5 weeks