Effectiveness of Muscles Energy Technique in the Management of Chronic Non-specific Low Back Pain
NCT ID: NCT03449810
Last Updated: 2021-07-26
Study Results
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Basic Information
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COMPLETED
NA
125 participants
INTERVENTIONAL
2019-01-01
2019-12-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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DSE plus MET (group A)
The DSE will consist of seven exercise activities that will be administered at random viz; 1. Bridging 2. Supine twist stretch 3. Double leg knee to chest stretch 4. Plank heel raise 5. Ball squat 6. Leg press on ball 7. Hip Lifts.
The MET procedure will involve a total of 5-10 contralateral isometric voluntary contractions that will be resisted by force equal to the participant's for 30 seconds with 5 seconds rest between contractions (corresponding to 20-30%).
DSE plus MET group A
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.
DSE only (group B)
The DSE will consist of seven exercise activities that will be administered at random viz; 1. Bridging 2. Supine twist stretch 3. Double leg knee to chest stretch 4. Plank heel raise 5. Ball squat 6. Leg press on ball 7. Hip Lifts.
DSE alone group B
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.
Standard Physiotherapy Treatment (group C)
This group will involve classical massage, therapeutic exercises (strengthening spinal and abdominal muscles) and a combination of interferential therapy and therapeutic ultrasound (INF/UTS) applied to the lumbosacral region. The participants will be asked to perform the therapeutic exercises once a day at home.
Standard Physiotherapy treatment group C
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.
Interventions
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DSE plus MET group A
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.
DSE alone group B
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.
Standard Physiotherapy treatment group C
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.
Eligibility Criteria
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Inclusion Criteria
2. Lumbar hypomobility; mobility deficits of the thorax and hip regions;
3. LBP not of specific origin diagnosed by a physician (due to fracture, tumours, malignancy, ankyloses, infections, and pregnancy);
4. Diminished trunk or pelvic region muscle strength and endurance;
5. Movement coordination impairments while performing community/work-related recreational or occupational activities.
6. Attending Outpatient clinics and Physiotherapy departments of Rasheed Shekoni Teaching Hospital Dutse and Federal medical centre Birnin-Kudu in Jigawa state, Northwest Nigeria.
Exclusion Criteria
2. Patients using immunosuppression or steroid medication.
3. Patients with persistent severe pain.
4. Patients with spinal deformities.
5. Patients with widespread neurological symptoms; patients with peritonitis as at the time of recruitment; patients with a history of lumbar surgery; patients diagnosed with carcinoma or organ disease; and patients with a history of severe rheumatic, orthopaedic, cardiovascular, systemic, metabolic or neurologic disorders.
20 Years
55 Years
ALL
No
Sponsors
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University of KwaZulu
OTHER
Responsible Party
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Usman Ahmed
Principal Investigator
Principal Investigators
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USMAN ABBA AHMED, MASTERS
Role: PRINCIPAL_INVESTIGATOR
University of KwaZulu
Maharaj S Sonill, PhD
Role: STUDY_CHAIR
University of KwaZulu
Nadasan N Thaya, PhD
Role: STUDY_DIRECTOR
University of KwaZulu
Locations
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Rasheed Shekoni Specialist Hospital
Dutse, Jigawa State, Nigeria
Countries
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References
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Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006 Jun 17;332(7555):1430-4. doi: 10.1136/bmj.332.7555.1430. No abstract available.
Manusov EG. Evaluation and diagnosis of low back pain. Prim Care. 2012 Sep;39(3):471-9. doi: 10.1016/j.pop.2012.06.003.
Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
Louw QA, Morris LD, Grimmer-Somers K. The prevalence of low back pain in Africa: a systematic review. BMC Musculoskelet Disord. 2007 Nov 1;8:105. doi: 10.1186/1471-2474-8-105.
Omokhodion FO. Low back pain in an urban population in Southwest Nigeria. Trop Doct. 2004 Jan;34(1):17-20. doi: 10.1177/004947550403400107.
Sikiru L, Shmaila H. Prevalence and risk factors of low back pain among nurses in Africa: Nigerian and Ethiopian specialized hospitals survey study. East Afr J Public Health. 2009 Apr;6(1):22-5. doi: 10.4314/eajph.v6i1.45737.
Cohen SP, Argoff CE, Carragee EJ. Management of low back pain. BMJ. 2008 Dec 22;337:a2718. doi: 10.1136/bmj.a2718. No abstract available.
Martell BA, O'Connor PG, Kerns RD, Becker WC, Morales KH, Kosten TR, Fiellin DA. Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Ann Intern Med. 2007 Jan 16;146(2):116-27. doi: 10.7326/0003-4819-146-2-200701160-00006.
Mitchell, F. L., & Mitchell, P. K. G. (1999). The muscle energy manual, 4196(517), 48826.
Franke H, Fryer G, Ostelo RW, Kamper SJ. Muscle energy technique for non-specific low-back pain. Cochrane Database Syst Rev. 2015 Feb 27;2015(2):CD009852. doi: 10.1002/14651858.CD009852.pub2.
Marshall PW, Murphy BA. Core stability exercises on and off a Swiss ball. Arch Phys Med Rehabil. 2005 Feb;86(2):242-9. doi: 10.1016/j.apmr.2004.05.004.
Hodges PW. Core stability exercise in chronic low back pain. Orthop Clin North Am. 2003 Apr;34(2):245-54. doi: 10.1016/s0030-5898(03)00003-8.
Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.
Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.
Selkow NM, Grindstaff TL, Cross KM, Pugh K, Hertel J, Saliba S. Short-term effect of muscle energy technique on pain in individuals with non-specific lumbopelvic pain: a pilot study. J Man Manip Ther. 2009;17(1):E14-8. doi: 10.1179/jmt.2009.17.1.14E.
Ahmed UA, Maharaj SS, Van Oosterwijck J. Effects of dynamic stabilization exercises and muscle energy technique on selected biopsychosocial outcomes for patients with chronic non-specific low back pain: a double-blind randomized controlled trial. Scand J Pain. 2021 Feb 24;21(3):495-511. doi: 10.1515/sjpain-2020-0133. Print 2021 Jul 27.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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Koes, B. W., Van Tulder, M. W., \& Thomas, S. (2006). Diagnosis and Treatment of Low Back Pain.
Balagué, F., Mannion, A. F., Pellisé, F., \& Cedraschi, C. (2012). Non-specific low back pain.
Louw QA, Morris LD, Grimmer-Somers K. The prevalence of low back pain in Africa: a systematic review
Sikiru, L., \& Shmaila, H. (2009). Prevalence and risk factors of low back pain among nurses in Africa: Nigerian and Ethiopian specialized hospitals survey study
Cohen SP, Argoff CE, Carragee EJ. Management of low back pain.
Marshall, P. W., \& Murphy, B. A. (2005). Core stability exercises on and off a Swiss ball.
Hodges, P. W. (2003). Core stability exercise in chronic low back pain.
ANOVA power analysis
Other Identifiers
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217077488
Identifier Type: -
Identifier Source: org_study_id
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