NCT03184220

Brief Summary

This study aimed to investigate the effects of myofascial release therapy (MRT) for improving pressure pain thresholds (PPTs), range of motion and pain in patients with mechanical neck pain (NP).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

May 18, 2017

Last Update Submit

April 12, 2019

Conditions

Keywords

Neck PainPhysical Therapy ModalitiesFasciaManual TherapyMassage

Outcome Measures

Primary Outcomes (1)

  • The intensity of cervical pain

    A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of cervical pain, and the worst and lowest level of pain experienced in the preceding week in the cervical area.

    Baseline

Secondary Outcomes (4)

  • The intensity of cervical pain

    Four weeks

  • The intensity of cervical pain

    Eight weeks

  • Active cervical range of motion

    Baseline, four weeks and eight weeks

  • Pressure pain thresholds in cervical trigger points

    Baseline, four weeks and eight weeks

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

Patients who are pregnant, have pacemaker and those surgically operated cervical spine patients who have been treated with myofascial therapy a month earlier. Multimodal physical therapy program includes: Myofascial syndrome cervical therapy treatment.

Procedure: Physiotherapy treatment

CONTROL GROUP

EXPERIMENTAL

Multimodal physical therapy program includes: * ultrasound therapy (US), * transcutaneous electric nerve stimulation (TENS) * massage.

Procedure: Physiotherapy treatment

Interventions

The MRT group was treated five times with several maneuvers. Each maneuver was performed once per session by slow and progressive application of a light force. The whole procedure lasted no more than 45 minutes. The treatment included four basic maneuvers. * Suboccipital induction * Posterior elongation of the cervical fascia in Supine position * Assisted cervical fascia * Myofascial induction of sternocleidomastoid

EXPERIMENTAL GROUP

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of both sexes, aged between 20 and 60 years, in an active state of pain and diagnosed with muscle breakdown

You may not qualify if:

  • \- Patients who are pregnant, have pacemakers and surgically operated in the area to be treated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlínica Santa maría

Cadiz, Cádiz, 11008, Spain

Location

Related Publications (24)

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    PMID: 23419913BACKGROUND
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    PMID: 15999284BACKGROUND
  • Palmlof L, Skillgate E, Alfredsson L, Vingard E, Magnusson C, Lundberg M, Holm LW. Does income matter for troublesome neck pain? A population-based study on risk and prognosis. J Epidemiol Community Health. 2012 Nov;66(11):1063-70. doi: 10.1136/jech-2011-200783. Epub 2012 Mar 12.

    PMID: 22412154BACKGROUND
  • Noormohammadpour P, Mansournia MA, Koohpayehzadeh J, Asgari F, Rostami M, Rafei A, Kordi R. Prevalence of Chronic Neck Pain, Low Back Pain, and Knee Pain and Their Related Factors in Community-Dwelling Adults in Iran: A Population-based National Study. Clin J Pain. 2017 Feb;33(2):181-187. doi: 10.1097/AJP.0000000000000396.

    PMID: 27258995BACKGROUND
  • De Pauw R, Coppieters I, Kregel J, De Meulemeester K, Danneels L, Cagnie B. Does muscle morphology change in chronic neck pain patients? - A systematic review. Man Ther. 2016 Apr;22:42-9. doi: 10.1016/j.math.2015.11.006. Epub 2015 Dec 11.

    PMID: 26724855BACKGROUND
  • Rodriguez-Fuentes I, De Toro FJ, Rodriguez-Fuentes G, de Oliveira IM, Meijide-Failde R, Fuentes-Boquete IM. Myofascial Release Therapy in the Treatment of Occupational Mechanical Neck Pain: A Randomized Parallel Group Study. Am J Phys Med Rehabil. 2016 Jul;95(7):507-15. doi: 10.1097/PHM.0000000000000425.

    PMID: 26745225BACKGROUND
  • Tozzi P, Bongiorno D, Vitturini C. Fascial release effects on patients with non-specific cervical or lumbar pain. J Bodyw Mov Ther. 2011 Oct;15(4):405-16. doi: 10.1016/j.jbmt.2010.11.003. Epub 2011 Jan 8.

    PMID: 21943614BACKGROUND
  • Lluch E, Nijs J, De Kooning M, Van Dyck D, Vanderstraeten R, Struyf F, Roussel NA. Prevalence, Incidence, Localization, and Pathophysiology of Myofascial Trigger Points in Patients With Spinal Pain: A Systematic Literature Review. J Manipulative Physiol Ther. 2015 Oct;38(8):587-600. doi: 10.1016/j.jmpt.2015.08.004. Epub 2015 Sep 19.

    PMID: 26387860BACKGROUND
  • Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.

    PMID: 21856077BACKGROUND
  • Munoz-Munoz S, Munoz-Garcia MT, Alburquerque-Sendin F, Arroyo-Morales M, Fernandez-de-las-Penas C. Myofascial trigger points, pain, disability, and sleep quality in individuals with mechanical neck pain. J Manipulative Physiol Ther. 2012 Oct;35(8):608-13. doi: 10.1016/j.jmpt.2012.09.003.

    PMID: 23158466BACKGROUND
  • Jeon JH, Jung YJ, Lee JY, Choi JS, Mun JH, Park WY, Seo CH, Jang KU. The effect of extracorporeal shock wave therapy on myofascial pain syndrome. Ann Rehabil Med. 2012 Oct;36(5):665-74. doi: 10.5535/arm.2012.36.5.665. Epub 2012 Oct 31.

    PMID: 23185731BACKGROUND
  • Cook AJ, Wellman RD, Cherkin DC, Kahn JR, Sherman KJ. Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes. Spine J. 2015 Oct 1;15(10):2206-15. doi: 10.1016/j.spinee.2015.06.049. Epub 2015 Jun 19.

    PMID: 26096474BACKGROUND
  • Lopez-Lopez A, Alonso Perez JL, Gonzalez Gutierez JL, La Touche R, Lerma Lara S, Izquierdo H, Fernandez-Carnero J. Mobilization versus manipulations versus sustain apophyseal natural glide techniques and interaction with psychological factors for patients with chronic neck pain: randomized controlled trial. Eur J Phys Rehabil Med. 2015 Apr;51(2):121-32. Epub 2014 Oct 9.

    PMID: 25296741BACKGROUND
  • Liptan G, Mist S, Wright C, Arzt A, Jones KD. A pilot study of myofascial release therapy compared to Swedish massage in fibromyalgia. J Bodyw Mov Ther. 2013 Jul;17(3):365-70. doi: 10.1016/j.jbmt.2012.11.010. Epub 2013 Jan 3.

    PMID: 23768283BACKGROUND
  • Moraska AF, Stenerson L, Butryn N, Krutsch JP, Schmiege SJ, Mann JD. Myofascial trigger point-focused head and neck massage for recurrent tension-type headache: a randomized, placebo-controlled clinical trial. Clin J Pain. 2015 Feb;31(2):159-68. doi: 10.1097/AJP.0000000000000091.

    PMID: 25329141BACKGROUND
  • Saiz-Llamosas JR, Fernandez-Perez AM, Fajardo-Rodriguez MF, Pilat A, Valenza-Demet G, Fernandez-de-Las-Penas C. Changes in neck mobility and pressure pain threshold levels following a cervical myofascial induction technique in pain-free healthy subjects. J Manipulative Physiol Ther. 2009 Jun;32(5):352-7. doi: 10.1016/j.jmpt.2009.04.009.

    PMID: 19539117BACKGROUND
  • 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: 25457196BACKGROUND
  • Calixtre LB, Moreira RF, Franchini GH, Alburquerque-Sendin F, Oliveira AB. Manual therapy for the management of pain and limited range of motion in subjects with signs and symptoms of temporomandibular disorder: a systematic review of randomised controlled trials. J Oral Rehabil. 2015 Nov;42(11):847-61. doi: 10.1111/joor.12321. Epub 2015 Jun 7.

    PMID: 26059857BACKGROUND
  • Serrano-Aguilar P, Kovacs FM, Cabrera-Hernandez JM, Ramos-Goni JM, Garcia-Perez L. Avoidable costs of physical treatments for chronic back, neck and shoulder pain within the Spanish National Health Service: a cross-sectional study. BMC Musculoskelet Disord. 2011 Dec 21;12:287. doi: 10.1186/1471-2474-12-287.

    PMID: 22188790BACKGROUND
  • Wong JJ, Shearer HM, Mior S, Jacobs C, Cote P, Randhawa K, Yu H, Southerst D, Varatharajan S, Sutton D, van der Velde G, Carroll LJ, Ameis A, Ammendolia C, Brison R, Nordin M, Stupar M, Taylor-Vaisey A. Are manual therapies, passive physical modalities, or acupuncture effective for the management of patients with whiplash-associated disorders or neck pain and associated disorders? An update of the Bone and Joint Decade Task Force on Neck Pain and Its Associated Disorders by the OPTIMa collaboration. Spine J. 2016 Dec;16(12):1598-1630. doi: 10.1016/j.spinee.2015.08.024. Epub 2015 Dec 17.

    PMID: 26707074BACKGROUND
  • Cagnie B, Castelein B, Pollie F, Steelant L, Verhoeyen H, Cools A. Evidence for the Use of Ischemic Compression and Dry Needling in the Management of Trigger Points of the Upper Trapezius in Patients with Neck Pain: A Systematic Review. Am J Phys Med Rehabil. 2015 Jul;94(7):573-83. doi: 10.1097/PHM.0000000000000266.

    PMID: 25768071BACKGROUND
  • 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: 26093806BACKGROUND
  • Fletcher JP, Bandy WD. Intrarater reliability of CROM measurement of cervical spine active range of motion in persons with and without neck pain. J Orthop Sports Phys Ther. 2008 Oct;38(10):640-5. doi: 10.2519/jospt.2008.2680.

    PMID: 18827326BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Manuel Rodriguez Huguet

    University of Cadiz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Blind researcher
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 18, 2017

First Posted

June 12, 2017

Study Start

November 1, 2017

Primary Completion

December 20, 2017

Study Completion

February 1, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations