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Myofascial Release Therapy and Mechanical Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy
Myofascial Release Therapy
Analgesic therapy
Sponsored by
FREMAP Mutual Insurance Company for Occupational Accidents and Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck Pain, Myofascial release, Manual therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • FREMAP - Mutual Insurance Company for Occupational Accidents and Diseases.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Manual Therapy + Analgesic therapy

Myofascial Release + Analgesic therapy

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Neck Pain
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

Quality of life
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).
Change from baseline Quality of life at 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).
Cervical disability
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).
Change from baseline cervical disability at 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).
Change from baseline cervical disability at 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).
Active cervical range of motion
Measured by a goniometer (SP-5060 CROM - cervical range of motion-, Performance Attainment Associates, St Paul, Minnesota, USA) (Haynes and Edmondston, 2002).
Change from baseline active cervical range of motion at 2 weeks
Measured by a goniometer (SP-5060 CROM - cervical range of motion-, Performance Attainment Associates, St Paul, Minnesota, USA) (Haynes and Edmondston, 2002).
Change from baseline active cervical range of motion at 4 weeks
Measured by a goniometer (SP-5060 CROM - cervical range of motion-, Performance Attainment Associates, St Paul, Minnesota, USA) (Haynes and Edmondston, 2002).
Craniovertebral angle
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).
Change from baseline craniovertebral angle at 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).
Change from baseline craniovertebral angle at 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).
Change from baseline neck pain at 2 weeks.
Assessed by the VAS, with a 2-point improvement being considered as clinically significant (Farrar et al., 2001; Cleland et al., 2007).
Change from baseline neck pain at 4 weeks.
Assessed by the VAS, with a 2-point improvement being considered as clinically significant (Farrar et al., 2001; Cleland et al., 2007).

Full Information

First Posted
January 13, 2015
Last Updated
January 22, 2015
Sponsor
FREMAP Mutual Insurance Company for Occupational Accidents and Diseases
Collaborators
University of Vigo, University Hospital A Coruña
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1. Study Identification

Unique Protocol Identification Number
NCT02348268
Brief Title
Myofascial Release Therapy and Mechanical Neck Pain
Official Title
Myofascial Release Therapy in the Treatment of Occupational Mechanical Neck Pain: a Randomized Parallel Group Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
FREMAP Mutual Insurance Company for Occupational Accidents and Diseases
Collaborators
University of Vigo, University Hospital A Coruña

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck Pain, Myofascial release, Manual therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy + Analgesic therapy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Myofascial Release + Analgesic therapy
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial Release Therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Analgesic therapy
Other Intervention Name(s)
TENS + IRR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neck Pain
Description
Assessed by the VAS, with a 2-point improvement being considered as clinically significant (Farrar et al., 2001; Cleland et al., 2007).
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Quality of life
Description
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).
Time Frame
Baseline
Title
Change from baseline Quality of life at 4 weeks
Description
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).
Time Frame
4 weeks
Title
Cervical disability
Description
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).
Time Frame
Baseline
Title
Change from baseline cervical disability at 2 weeks
Description
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).
Time Frame
2 weeks
Title
Change from baseline cervical disability at 4 weeks
Description
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).
Time Frame
4 weeks
Title
Active cervical range of motion
Description
Measured by a goniometer (SP-5060 CROM - cervical range of motion-, Performance Attainment Associates, St Paul, Minnesota, USA) (Haynes and Edmondston, 2002).
Time Frame
Baseline
Title
Change from baseline active cervical range of motion at 2 weeks
Description
Measured by a goniometer (SP-5060 CROM - cervical range of motion-, Performance Attainment Associates, St Paul, Minnesota, USA) (Haynes and Edmondston, 2002).
Time Frame
2 weeks
Title
Change from baseline active cervical range of motion at 4 weeks
Description
Measured by a goniometer (SP-5060 CROM - cervical range of motion-, Performance Attainment Associates, St Paul, Minnesota, USA) (Haynes and Edmondston, 2002).
Time Frame
4 weeks
Title
Craniovertebral angle
Description
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).
Time Frame
Baseline
Title
Change from baseline craniovertebral angle at 2 weeks
Description
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).
Time Frame
2 weeks
Title
Change from baseline craniovertebral angle at 4 weeks
Description
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).
Time Frame
4 weeks
Title
Change from baseline neck pain at 2 weeks.
Description
Assessed by the VAS, with a 2-point improvement being considered as clinically significant (Farrar et al., 2001; Cleland et al., 2007).
Time Frame
2 weeks
Title
Change from baseline neck pain at 4 weeks.
Description
Assessed by the VAS, with a 2-point improvement being considered as clinically significant (Farrar et al., 2001; Cleland et al., 2007).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco J DeToro-Santos, Ph.D.
Organizational Affiliation
Department of Medicine, University of A Coruña.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Isaac M Fuentes-Boquete, Ph.D.
Organizational Affiliation
Department of Medicine, University of A Coruña.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Iván Rodríguez-Fuentes, Ph.D.
Organizational Affiliation
FREMAP Mutual Insurance Company for Occupational Accidents and Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
FREMAP - Mutual Insurance Company for Occupational Accidents and Diseases.
City
A Coruña
ZIP/Postal Code
15009
Country
Spain

12. IPD Sharing Statement

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Myofascial Release Therapy and Mechanical Neck Pain

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