Effectiveness of Muscles Energy Technique in the Management of Chronic Non-specific Low Back Pain
Condition: Chronic Non-specific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain is the most common health problem that affects work performance and quality of
      life. Non-specific low back pain (NSLBP) is defined as low back pain not attributable to a
      recognizable, known specific pathology. NSLBP is the leading cause of disability among the
      major musculoskeletal conditions which leads to Impairments, Activity Limitations and
      participation restrictions. Therefore it becomes a psychosocial/economic burden on
      individuals, families, communities, industries and government. Existing literature shows
      globally 40% to 50% of people have LBP at some point in their lives and there exists a
      challenge in Africa on the best rehabilitation methods for low back pain management which
      could prevent chronic pain and disability. Therefore, this study aims to determine the
      effectiveness of MET when combined with DSE in the management of chronic NSLBP patients and
      to analyze the additional effect the MET procedure will provide relative to DSE.
    

Detailed description: 
      Low back pain (LBP) is arguably the most prevalent musculoskeletal condition found among both
      developed and developing nations. Broadly defined as pain or discomfort in the lumbar region
      of the spine it is the leading cause of activity limitations, resulting in significant losses
      in productivity at work and incurs billions of dollars in medical expenditure annually. The
      prevalence of LBP worldwide is estimated to be between 30 and 80% among the general
      population and has been found to increase with age. In addition, a higher prevalence of LBP
      has been associated with lower socioeconomic status and lower education levels. According to
      the Global Burden of Disease (GBD) 2010 study, LBP is currently the 6th highest burden on a
      list of 291 conditions and is the cause of more years lived with disability globally than any
      other disease. Affecting just about anyone, of any gender, race or socioeconomic background,
      LBP has a substantial impact on the overall and financial well-being of an individual and
      society.

      Therefore, it was postulated that the burden of LBP would be greater in lower and
      middle-income countries like those situated in Africa. A recent systematic review and
      meta-analysis published in 2018 revealed that the lifetime, annual and point prevalence of
      LBP among African nations, was higher than the global LBP prevalence. The majority of the
      studies included in this meta-analysis were conducted in Nigeria, which is a
      lower-middle-income country. In Nigeria, the annual prevalence rate of LBP has been reported
      between 33% and 74%, mostly affecting workers. The prognosis after an acute episode of LBP is
      less favourable than once thought, as 60-80% of the patients will experience recurrence or
      persistence of this disabling condition.12 Despite the high incidence and prevalence of LBP,
      little is known about the precise causes. As a clear pathoanatomic diagnosis cannot be
      identified in 85% of the patients,13 LBP in these patients is labelled as non-specific
      (NSLBP).

      Despite extensive research, the issue of spinal pain management still constitutes a challenge
      for physicians, physiotherapists, and researchers. There are many therapies claimed to be
      useful for the treatment of NSLBP, but most of these treatments have not been well
      investigated or have been found to have modest effects in terms of pain relief and improving
      disability. Conservative treatment remains the best choice and usually involves
      physiotherapy. Exercise therapy is one of the most used treatment strategies as it has shown
      to be effective in decreasing pain and disability, and can even induce functional changes of
      the back muscles. Although, exercise therapy in highly recommend by experts in treatment
      guidelines, the evidenced treatment effects remain low to moderate. It is, therefore, useful
      to further explore the effectiveness of treatments that may assist people with NSLBP.
      Another, non-invasive, safe and inexpensive treatment technique used by physiotherapists,
      osteopaths, chiropractors and manual therapists in the treatment of NSLBP is Muscle Energy
      Technique (MET). MET involves alternating periods of resisted muscle contractions and
      assisted stretching. Although it has been suggested that MET can be used to lengthen a
      shortened muscle, mobilize an articulation with restricted mobility, strengthen a
      physiologically weakened muscle and reduce localized oedema and passive congestion, the
      physiological mechanisms underlying the therapeutic effects of MET are currently unclear.
      Mechanisms of altered proprioception, motor programming and control have been proposed, but
      research is required to confirm these hypotheses. While MET is often used for the treatment
      of NSLBP, a recent Cochrane review concluded that there is lack of empirical evidence on its
      effectiveness in the management of chronic NSLBP. These conclusions were made not because of
      the lack of treatment effectiveness, but because the currently available studies have been
      generally performed in too small study samples and have a high risk of bias, producing
      unreliable answers about this therapy. In conclusion, the Cochrane review emphasized the need
      for larger, high-quality studies to determine the effectiveness and safety of MET in chronic
      NSLBP.

      Therefore, the aims of this study are to determine the effectiveness of MET when combined
      with DSE in the management of chronic NSLBP patients and to analyze the additional effect the
      MET procedure will provide relative to DSE. Thus, the efficacy of the combination of MET plus
      DSE will be compared with outcomes of treatment with DSE or standard physiotherapy (SP) in
      the management of chronic NSLBP. The study will evaluate the effect of each intervention on
      trunk Range of Motion (ROM), muscle functions (limited to muscles strength, endurance, force
      and Maximal voluntary contraction [MVC]), Quality of Life (QoL), functional disability,
      activity limitations and participation restrictions.

      The primary goal of this study is to evaluate the effects of MET in combination with DSE on
      quality of life and trunk muscles functions in patients with chronic NSLBP, however, the
      study involves the following as general goal that needs to be realized;

        1. To conduct a systematic review (scoping) of the literature on the effectiveness of MET
           in the management NSLBP.

        2. To cross-culturally adapt and psychometrically validate the Nigerian Hausa Version of
           Örebro Musculoskeletal Pain Screening Questionnaire.

        3. To conduct an online survey to determine the knowledge and skills of Nigerian
           physiotherapist on the application of MET in the management of NSLBP.

        4. To evaluate the working mechanism of MET on the trunk muscle function by studying
           several muscular properties (recruitment, endurance, fatigability, flexibility) in
           chronic NSLBP.

        5. To conduct a randomized control trial (RCT) to determine the short-term (6 weeks, 12
           weeks) and long term (3 months) effectiveness of MET in combination with DSE on back
           muscles function and on clinical outcomes of functionality (such as disability, quality
           of life, and activity and participation restrictions) in patients with chronic NSLBP.

      Therefore, the RCT component of this research has the following objectives.

        1. To determine the effectiveness of MET in combination with DSE in the management of
           chronic NSLBP patients by assessing their influencing on trunk muscles functions limited
           to trunk muscles endurance, Transverses abdominus muscles contraction rate, trunk ROM,
           QoL, functional disability, global rating of change scale (GROCS), activity limitations
           and participation restrictions.

        2. To evaluate the additional effect of MET relative to DSE on the study outcomes in the
           management of chronic NSLBP patients.

        3. To compare the therapeutic effect of MET plus DSE with outcomes of treatment with DSE or
           standard physiotherapy (SP) in the management of chronic NSLBP

        4. To assess all outcomes at baseline, 6th week and 12th week of the study interventions.

        5. To also conduct a 3 months follow-up evaluation on outcomes to determine if the
           intervention effect is retained within the period. The ultimate goal is to provide
           recommendations (based on the study findings) for the implementation and use of MET in
           the Nigerian Health Care System for the management of chronic NSLBP.
    

Intervention name(s): DSE plus MET group A; DSE alone group B; Standard Physiotherapy treatment group C
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The Dynamic stabilization exercises will consist of seven exercises, which are aimed to strengthen the lumbar stabilizing muscles. All seven dynamic stabilization exercises will be performed once and always in random order.
The procedure for MET involves voluntary contraction of the participant's muscle in a precisely controlled direction, at varying levels of intensity, against a distinctly executed counterforce applied by the therapist. In this type of therapy, a participant contracts muscles by pushing against resistance provided by the therapist. The therapist then assists the participant in stretching, strengthening and relaxing those muscles.; The DSE in this arm is the same a described in group A, i.e. it involves seven exercises activities administered randomly at every session of the study intervention.; In the control group, the participants will receive standard physiotherapy treatment offered for the management of chronic NSLBP patients in Nigeria. Therefore, individuals randomized to this therapeutic group will be treated with classical massage, therapeutic exercises and a combination of interferential therapy and therapeutic ultrasound (INF/UTS) applied to the lumbosacral region.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The Intervention Models Includes; Muscles Energy Technique plus Dynamic stabilization exercises which would be administered to participants in group A, Dynamic stabilization exercises to be administered to group B participants and group C which is the control will receive standard physiotherapy treatment.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MET, Low Back Pain, Stabilization exercises; Quality of Life, Functional disability