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FibromyalgiaNCT02864524

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

A study testing Manipulative and Massage Therapy and Exercise Program in people with Fibromyalgia, run by Universidad de Almeria at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Fibromyalgia
What is being tested?
Manipulative and Massage Therapy and Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteSpain
Study dates
Aug 2016to Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Adelaida María Castro-Sánchez

    Almería, 04120

Other trials in Spain

About this study

Official title: 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.

Conditions
Fibromyalgia
Being tested
Manipulative and Massage Therapy, Exercise Program
Keywords
Physical Therapy Modalities, Exercises, Musculoskeletal Manipulations
Medical subject headings
Fibromyalgia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manipulative and Massage TherapyOther

  • Exercise ProgramOther

Study groups in NCT02864524
Study groupRoleWhat they receive
Manipulative and Massage TherapyExperimentalTen 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):
Receives: Other: Manipulative and Massage Therapy
Exercise ProgramActive comparatorTen sessions (2 time/ week): Initial heating and continuing with aerobic and muscle stretching exercises.
Receives: Other: Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity

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

    Measured: Changes from Baseline, and 5 weeks

Secondary outcomes (9)

  1. McGill Pain Questionnaire

    Measured: Changes from Baseline, and 5 weeks

  2. Pittsburgh Quality of Life Questionnaire

    Measured: Changes from Baseline, and 5 weeks

  3. Quality of Life Questionnaire (SF-36)

    Measured: Changes from Baseline, and 5 weeks

  4. Fibromyalgia Impact Questionnaire (FIQ)

    Measured: Changes from Baseline, and 5 weeks

  5. Hospital Anxiety and Depression Scale (HADS)

    Measured: Changes from Baseline, and 5 weeks

  6. Beck Depression Inventory

    Measured: Changes from Baseline, and 5 weeks

  7. Fatigue Impact Scale (FIS)

    Measured: Changes from Baseline, and 5 weeks

  8. Schöber Test

    Measured: Changes from Baseline, and 5 weeks

  9. Pressure Algometry

    Measured: Changes from Baseline, and 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionNov 2020
  4. Study completionJun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02864524
Sponsor's protocol ID
UAL-499
Status last verified
Nov 2020
First submitted
9 Aug 2016
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27473164

  • 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.

    PubMed 27457628

  • 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.

    PubMed 27377815

  • 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.

    PubMed 27312858

  • 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.

    PubMed 27306300

  • 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.

    PubMed 27297077

  • 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.

    PubMed 27296860

  • 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.

    PubMed 26093806

  • 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.

    PubMed 25782585

  • 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.

    PubMed 25457196

  • 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.

    PubMed 24586677

Questions about this trial

What is this clinical trial studying?

A study testing Manipulative and Massage Therapy and Exercise Program in people with Fibromyalgia, run by Universidad de Almeria at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (time frame: Changes from Baseline, and 5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02864524, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.

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