NCT02348268

Brief Summary

Mechanical neck pain is a musculoskeletal disorder usually associated with work absenteeism. Myofascial release therapy (MRT) is currently under development and has the treatment of mechanical neck pain as one of its main focal points. However, there is a paucity of studies reporting its effectiveness. For that purpose a randomized single-blind parallel group study was designed to compare the effectiveness of MRT with manual therapy (MT) for treating occupational mechanical neck pain. The sample (n=59) was randomly assigned to two therapeutic intervention programs. Group I patients were treated with MT and Group II patients were treated with MRT. Variables studied were intensity of neck pain, cervical disability, quality of life (QoL), craniovertebral angle and ranges of cervical motion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

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

Study Start

First participant enrolled

January 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

January 13, 2015

Last Update Submit

January 22, 2015

Conditions

Keywords

Neck PainMyofascial releaseManual therapy

Outcome Measures

Primary Outcomes (1)

  • Neck Pain

    Assessed by the VAS, with a 2-point improvement being considered as clinically significant (Farrar et al., 2001; Cleland et al., 2007).

    Baseline

Secondary Outcomes (13)

  • Quality of life

    Baseline

  • Change from baseline Quality of life at 4 weeks

    4 weeks

  • Cervical disability

    Baseline

  • Change from baseline cervical disability at 2 weeks

    2 weeks

  • Change from baseline cervical disability at 4 weeks

    4 weeks

  • +8 more secondary outcomes

Study Arms (2)

Manual Therapy + Analgesic therapy

ACTIVE COMPARATOR

The intervention for this group consisted of analgesic treatment in accordance with the guidelines of the FREMAP Protocol for the treatment of mechanical NP and additionally this group was treated with manual therapy (for 15 minutes).

Other: Manual TherapyDevice: Analgesic therapy

Myofascial Release + Analgesic therapy

EXPERIMENTAL

The intervention for this group consisted of analgesic treatment in accordance with the guidelines of the FREMAP Protocol for the treatment of mechanical NP and additionally, this group was treated with myofascial release therapy (for 15 minutes).

Other: Myofascial Release TherapyDevice: Analgesic therapy

Interventions

The manual therapy techniques included: (i) anterior-posterior and side-shift of the cervical spine; (ii) muscle energy technique involving side-bending of cervical spine; (iii) neuromuscular technique for restricted C1-C2 rotation; (iv) inhibitive occipital distraction; and (v) cervical stretching: post-isometric relaxation for the upper trapezius, scalene and sternocleidomastoid muscles.

Manual Therapy + Analgesic therapy

The myofascial release therapy techniques included: (i) cranial base release, adjusting the relation of the rectus capitis posterior muscles to the dura mater; (ii) gross release of the sternocleidomastoid muscle; (iii) release of the suprahyoid and infrahyoid muscles; and (iv) release of the retrohyoid fascia.

Myofascial Release + Analgesic therapy

Analgesic therapy consisted of superficial thermotherapy by an infrared lamp (Infra 2000, Enraf Nonius) and TENS (TENSMED 911, Enraf Nonius). The 250-watts infrared lamp was focused at a distance of 50 cm on the cervical area for 15 minutes. TENS employed 80 Hz frequency, 150 µs pulse duration, with 50x50 mm electrodes (Gel-Trode, Enraf Nonius) placed on the painful or metamers areas for 20 minutes.

Also known as: TENS + IRR
Manual Therapy + Analgesic therapyMyofascial Release + Analgesic therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being between 18 and 65 years old; having mechanical neck pain with or without symptoms that radiated to the head and/or upper limbs (Guzman et al., 2009b); and
  • scoring 10% or higher on the Neck Disability Index (NDI) or 2 points or more on the Visual Analogue Scale (VAS) of pain at initial evaluation (Farrar et al., 2001; Cleland et al., 2007).

You may not qualify if:

  • Neck pain due to neoplasia, metastasis, severe osteoporosis, infectious or inflammatory processes, fractures, congenital anomalies, herniated disc, whiplash or cervical stenosis;
  • evidence of cervical spinal cord compromise or radiculopathy; previous neck surgery;
  • neck pain accompanied by dizziness caused by vertebrobasilar insufficiency or by headaches excluding those of cervical origin; and
  • pregnant women. Patients were also excluded if they had received physiotherapy treatment in the previous three months; and had pending legal actions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FREMAP - Mutual Insurance Company for Occupational Accidents and Diseases.

A Coruña, A Coruña, 15009, Spain

Location

Related Publications (34)

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    PMID: 1589462BACKGROUND
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    PMID: 19521013BACKGROUND
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    PMID: 20510644BACKGROUND
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    PMID: 19251069BACKGROUND
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    PMID: 19251061BACKGROUND
  • Langevin HM, Cornbrooks CJ, Taatjes DJ. Fibroblasts form a body-wide cellular network. Histochem Cell Biol. 2004 Jul;122(1):7-15. doi: 10.1007/s00418-004-0667-z. Epub 2004 Jun 23.

    PMID: 15221410BACKGROUND
  • Salt E, Wright C, Kelly S, Dean A. A systematic literature review on the effectiveness of non-invasive therapy for cervicobrachial pain. Man Ther. 2011 Feb;16(1):53-65. doi: 10.1016/j.math.2010.09.005. Epub 2010 Nov 12.

    PMID: 21075037BACKGROUND
  • Ball TM. Structural integration-based fascial release efficacy in systemic lupus erythematosus (SLE): two case studies. J Bodyw Mov Ther. 2011 Apr;15(2):217-25. doi: 10.1016/j.jbmt.2010.10.006. Epub 2010 Nov 19.

  • Ercole B, Antonio S, Julie Ann D, Stecco C. How much time is required to modify a fascial fibrosis? J Bodyw Mov Ther. 2010 Oct;14(4):318-25. doi: 10.1016/j.jbmt.2010.04.006. Epub 2010 May 20.

  • Bronfort G, Evans R, Nelson B, Aker PD, Goldsmith CH, Vernon H. A randomized clinical trial of exercise and spinal manipulation for patients with chronic neck pain. Spine (Phila Pa 1976). 2001 Apr 1;26(7):788-97; discussion 798-9. doi: 10.1097/00007632-200104010-00020.

  • Castro-Sanchez AM, Mataran-Penarrocha GA, Granero-Molina J, Aguilera-Manrique G, Quesada-Rubio JM, Moreno-Lorenzo C. Benefits of massage-myofascial release therapy on pain, anxiety, quality of sleep, depression, and quality of life in patients with fibromyalgia. Evid Based Complement Alternat Med. 2011;2011:561753. doi: 10.1155/2011/561753. Epub 2010 Dec 28.

  • Day JA, Stecco C, Stecco A. Application of Fascial Manipulation technique in chronic shoulder pain--anatomical basis and clinical implications. J Bodyw Mov Ther. 2009 Apr;13(2):128-35. doi: 10.1016/j.jbmt.2008.04.044. Epub 2008 Jun 24.

  • Fernandez-de-las-Penas C, Alonso-Blanco C, Cuadrado ML, Pareja JA. Forward head posture and neck mobility in chronic tension-type headache: a blinded, controlled study. Cephalalgia. 2006 Mar;26(3):314-9. doi: 10.1111/j.1468-2982.2005.01042.x.

  • Fernandez-de-las-Penas C, Alonso-Blanco C, Cuadrado ML, Pareja JA. Neck mobility and forward head posture are not related to headache parameters in chronic tension-type headache. Cephalalgia. 2007 Feb;27(2):158-64. doi: 10.1111/j.1468-2982.2006.01247.x.

  • Fernandez-de-las-Penas C, Perez-de-Heredia M, Molero-Sanchez A, Miangolarra-Page JC. Performance of the craniocervical flexion test, forward head posture, and headache clinical parameters in patients with chronic tension-type headache: a pilot study. J Orthop Sports Phys Ther. 2007 Feb;37(2):33-9. doi: 10.2519/jospt.2007.2401.

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  • Ramos-Gonzalez E, Moreno-Lorenzo C, Mataran-Penarrocha GA, Guisado-Barrilao R, Aguilar-Ferrandiz ME, Castro-Sanchez AM. Comparative study on the effectiveness of myofascial release manual therapy and physical therapy for venous insufficiency in postmenopausal women. Complement Ther Med. 2012 Oct;20(5):291-8. doi: 10.1016/j.ctim.2012.03.005. Epub 2012 May 3.

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  • 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.

MeSH Terms

Conditions

Neck Pain

Interventions

Musculoskeletal ManipulationsMyofascial Release TherapyTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMassageTherapy, Soft TissueElectric Stimulation TherapyAnalgesiaAnesthesia and Analgesia

Study Officials

  • Francisco J DeToro-Santos, Ph.D.

    Department of Medicine, University of A Coruña.

    STUDY DIRECTOR
  • Isaac M Fuentes-Boquete, Ph.D.

    Department of Medicine, University of A Coruña.

    STUDY CHAIR
  • Iván Rodríguez-Fuentes, Ph.D.

    FREMAP Mutual Insurance Company for Occupational Accidents and Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 28, 2015

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations