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Myofascial Release Therapy and Mechanical Neck Pain

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ClinicalTrials.gov Identifier: NCT02348268
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : January 28, 2015
Sponsor:
Collaborators:
University of Vigo
University Hospital A Coruña
Information provided by (Responsible Party):
Iván Rodríguez Fuentes, FREMAP Mutual Insurance Company for Occupational Accidents and Diseases

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.

Condition or disease Intervention/treatment Phase
Neck Pain Other: Manual Therapy Other: Myofascial Release Therapy Device: Analgesic therapy Not Applicable

Detailed Description:

A variety of physiotherapy interventions have been used to treat mechanical neck pain (NP), but few of them have proven effective. The number of studies on the clinical effectiveness of MT techniques, such as myofascial release therapy (MRT), has seen a marked increase. MRT is a relatively new therapy with increasing acceptance and implementation in the daily clinical work of physiotherapists. However, there is a paucity of studies on biomechanical alterations associated with mechanical NP and its treatment with MRT, consequently, the clinical benefits of MRT remain unclear.

The purpose of this study was to assess the clinical efficacy of MRT in occupational mechanical NP and to determine if MRT has advantages over another MT protocol not including MRT.

An experimental parallel group study was designed. It was a single-blind (assessor) randomized controlled clinical trial. Patients from FREMAP - Mutual Insurance Company for Occupational Accidents and Diseases - participated in the study from January 2010 to December 2010. A total of 71 patients were asked to participate in the initial screening, but 8 did not meet inclusion criteria, 2 declined to participate in the study for personal reasons, and 2 could not participate for other reasons. 59 patients with NP were randomly distributed into two groups according to two therapeutic intervention programs. Group I (n=29; 18 females/11 males; mean age: 38.24 ± 11.35 years-old) was treated with MT and Group II (n=30; 15 females/15 males; mean age: 38.20 ± 10.70 years-old) was treated with MRT.

The intervention for both groups consisted of analgesic treatment in accordance with the guidelines of the FREMAP Protocol for the treatment of mechanical NP. The analgesic part of this protocol includes superficial thermotherapy (infrared lamp) and transcutaneous electrical stimulation (TENS). Additionally, Group I was treated with MT and Group II with MRT. There were 10 treatment sessions distributed within 4 successive weeks with three sessions being applied the first and third weeks and two sessions being applied the second and fourth weeks.

MT was provided by one physiotherapist, while MRT was performed by another physiotherapist, both from FREMAP. The sessions were held for nearly 50 minutes, until the completion of the intervention as determined by FREMAP.

Analgesic therapy consisted of the application 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 application 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.

The additional treatments were applied for both groups for 15 minutes. MT 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.

The MRT included: (i) cranial base release, adjusting the relation of the rectus capitis posterior muscles to the dura mater (Hack et al., 1995); (ii) gross release of the sternocleidomastoid muscle; (iii) release of the suprahyoid and infrahyoid muscles; and (iv) release of the retrohyoid fascia.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Myofascial Release Therapy in the Treatment of Occupational Mechanical Neck Pain: a Randomized Parallel Group Study.
Study Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Manual Therapy + Analgesic therapy
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 Therapy
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.

Device: 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.
Other Name: TENS + IRR

Experimental: Myofascial Release + Analgesic therapy
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 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.

Device: 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.
Other Name: TENS + IRR




Primary Outcome Measures :
  1. Neck Pain [ Time Frame: Baseline ]
    Assessed by the VAS, with a 2-point improvement being considered as clinically significant (Farrar et al., 2001; Cleland et al., 2007).


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Baseline ]
    Measured by the Short-Form Health Survey 36, (SF-36), which includes 8 dimensions: physical function (PF), role physical (RP), bodily pain (BP), general health (GH), mental health (MH), role emotional (RE), social functioning (SF) and vitality (VT), and comprises two global scales: the Physical Component Summary (PCS) and the Mental Component Summary (MCS) (Ware and Sherburne, 1992; Alonso et al., 1995; Hays et al., 1995).

  2. Change from baseline Quality of life at 4 weeks [ Time Frame: 4 weeks ]
    Measured by the Short-Form Health Survey 36, (SF-36), which includes 8 dimensions: physical function (PF), role physical (RP), bodily pain (BP), general health (GH), mental health (MH), role emotional (RE), social functioning (SF) and vitality (VT), and comprises two global scales: the Physical Component Summary (PCS) and the Mental Component Summary (MCS) (Ware and Sherburne, 1992; Alonso et al., 1995; Hays et al., 1995).

  3. Cervical disability [ Time Frame: Baseline ]
    Assessed by the Neck Disability Index (NDI), range of 0 to 50 and total scores expressed as a percentage (internal consistency of alfa: 0.74 to 0.93 and a minimum clinically difference of 5 points) (Westaway et al., 1998; Vernon, 2008).

  4. Change from baseline cervical disability at 2 weeks [ Time Frame: 2 weeks ]
    Assessed by the Neck Disability Index (NDI), range of 0 to 50 and total scores expressed as a percentage (internal consistency of alfa: 0.74 to 0.93 and a minimum clinically difference of 5 points) (Westaway et al., 1998; Vernon, 2008).

  5. Change from baseline cervical disability at 4 weeks [ Time Frame: 4 weeks ]
    Assessed by the Neck Disability Index (NDI), range of 0 to 50 and total scores expressed as a percentage (internal consistency of alfa: 0.74 to 0.93 and a minimum clinically difference of 5 points) (Westaway et al., 1998; Vernon, 2008).

  6. Active cervical range of motion [ Time Frame: Baseline ]
    Measured by a goniometer (SP-5060 CROM - cervical range of motion-, Performance Attainment Associates, St Paul, Minnesota, USA) (Haynes and Edmondston, 2002).

  7. Change from baseline active cervical range of motion at 2 weeks [ Time Frame: 2 weeks ]
    Measured by a goniometer (SP-5060 CROM - cervical range of motion-, Performance Attainment Associates, St Paul, Minnesota, USA) (Haynes and Edmondston, 2002).

  8. Change from baseline active cervical range of motion at 4 weeks [ Time Frame: 4 weeks ]
    Measured by a goniometer (SP-5060 CROM - cervical range of motion-, Performance Attainment Associates, St Paul, Minnesota, USA) (Haynes and Edmondston, 2002).

  9. Craniovertebral angle [ Time Frame: Baseline ]
    Assessed by a universal goniometer manufactured by 3B Scientific Products (Valencia, Spain) that incorporates a bubble level torpedo (Würth SA, Barcelona, Spain) (Wilmarth and Hilliard, 2002).

  10. Change from baseline craniovertebral angle at 2 weeks [ Time Frame: 2 weeks ]
    Assessed by a universal goniometer manufactured by 3B Scientific Products (Valencia, Spain) that incorporates a bubble level torpedo (Würth SA, Barcelona, Spain) (Wilmarth and Hilliard, 2002).

  11. Change from baseline craniovertebral angle at 4 weeks [ Time Frame: 4 weeks ]
    Assessed by a universal goniometer manufactured by 3B Scientific Products (Valencia, Spain) that incorporates a bubble level torpedo (Würth SA, Barcelona, Spain) (Wilmarth and Hilliard, 2002).

  12. Change from baseline neck pain at 2 weeks. [ Time Frame: 2 weeks ]
    Assessed by the VAS, with a 2-point improvement being considered as clinically significant (Farrar et al., 2001; Cleland et al., 2007).

  13. Change from baseline neck pain at 4 weeks. [ Time Frame: 4 weeks ]
    Assessed by the VAS, with a 2-point improvement being considered as clinically significant (Farrar et al., 2001; Cleland et al., 2007).



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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348268


Locations
Layout table for location information
Spain
FREMAP - Mutual Insurance Company for Occupational Accidents and Diseases.
A Coruña, Spain, 15009
Sponsors and Collaborators
FREMAP Mutual Insurance Company for Occupational Accidents and Diseases
University of Vigo
University Hospital A Coruña
Investigators
Layout table for investigator information
Study Director: Francisco J DeToro-Santos, Ph.D. Department of Medicine, University of A Coruña.
Study Chair: Isaac M Fuentes-Boquete, Ph.D. Department of Medicine, University of A Coruña.
Principal Investigator: Iván Rodríguez-Fuentes, Ph.D. FREMAP Mutual Insurance Company for Occupational Accidents and Diseases
Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Iván Rodríguez Fuentes, Ph.D., FREMAP Mutual Insurance Company for Occupational Accidents and Diseases
ClinicalTrials.gov Identifier: NCT02348268    
Other Study ID Numbers: FREMAP
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015
Keywords provided by Iván Rodríguez Fuentes, FREMAP Mutual Insurance Company for Occupational Accidents and Diseases:
Neck Pain
Myofascial release
Manual therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Neck Pain
Pain
Neurologic Manifestations
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs