Clinical Trial: Myofascial Release Therapy and Mechanical Neck Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Myofascial Release Therapy in the Treatment of Occupational Mechanical Neck Pain: a Randomized Parallel Group Study.

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 Summary:

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 (
Sponsor: FREMAP Mutual Insurance Company for Occupational Accidents and Diseases

Current Primary Outcome: Neck Pain [ Time Frame: Baseline ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).
• 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).

Original Secondary Outcome: Same as current

Information By: FREMAP Mutual Insurance Company for Occupational Accidents and Diseases

Dates:
Date Received: January 13, 2015
Date Started: January 2010
Date Completion:
Last Updated: January 22, 2015
Last Verified: January 2015