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

NCT02864524 | Unknown

• 1 other identifier: UAL-499
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Physical Therapy Modalities; Exercises; Musculoskeletal Manipulations

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  A 10-point numerical scale (0 = no pain, 10: very severe pain)

  Changes from Baseline, and 5 weeks

Secondary Outcomes (9)

• McGill Pain Questionnaire

  Changes from Baseline, and 5 weeks

• Pittsburgh Quality of Life 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

• Hospital Anxiety and Depression Scale (HADS)

  Changes from Baseline, and 5 weeks

Study Arms (2)

Manipulative and Massage Therapy

EXPERIMENTAL

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

Exercise Program

ACTIVE COMPARATOR

Ten sessions (2 time/ week): Initial heating and continuing with aerobic and muscle stretching exercises.

Other: Exercise Program

Interventions

Manipulative and Massage Therapy OTHER

Manipulative and Massage Therapy

Exercise Program OTHER

Exercise Program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Adelaida María Castro-Sánchez

Almería, 04120, Spain

Location

Related Publications (11)

• 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.

  PMID: 27473164 BACKGROUND

• 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.

  PMID: 27457628 BACKGROUND

• 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.

  PMID: 27377815 BACKGROUND

• 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.

  PMID: 27312858 BACKGROUND

• 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.

  PMID: 27306300 BACKGROUND

• 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.

  PMID: 27297077 BACKGROUND

• 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.

  PMID: 27296860 BACKGROUND

• 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.

  PMID: 26093806 BACKGROUND

• 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.

  PMID: 25782585 BACKGROUND

• 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.

  PMID: 25457196 BACKGROUND

• 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.

  PMID: 24586677 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Interventions

Massage; Resistance Training

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: June 1, 2021
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)