Chronic Non-specific Low Back PainMETNCT03449810
Effectiveness of Muscles Energy Technique in the Management of Chronic Non-specific Low Back Pain
A study testing DSE plus MET group A, DSE alone group B and Standard Physiotherapy treatment group C in people with Chronic Non-specific Low Back Pain, run by University of KwaZulu at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Chronic Non-specific Low Back Pain
- What is being tested?
- DSE plus MET group A, DSE alone group B and Standard Physiotherapy treatment group C
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Jan 2019to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- NSLBP history of about or more than 3 months and associated with referred lower extremity pain; pain in the lumbopelvic region;
- Lumbar hypomobility; mobility deficits of the thorax and hip regions;
- LBP not of specific origin diagnosed by a physician (due to fracture, tumours, malignancy, ankyloses, infections, and pregnancy);
- Diminished trunk or pelvic region muscle strength and endurance;
- Movement coordination impairments while performing community/work-related recreational or occupational activities.
- Attending Outpatient clinics and Physiotherapy departments of Rasheed Shekoni Teaching Hospital Dutse and Federal medical centre Birnin-Kudu in Jigawa state, Northwest Nigeria.
Who cannot join
- Chronic NSLBP with radiating pain due to nerve root involvement in physical examination.
- Patients using immunosuppression or steroid medication.
- Patients with persistent severe pain.
- Patients with spinal deformities.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Muscles Energy Technique on Quality of Life and Trunk Muscles Functions in Patients With Chronic Non-specific Low Back Pain
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.
Read the 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;
- To conduct a systematic review (scoping) of the literature on the effectiveness of MET in the management NSLBP.
- To cross-culturally adapt and psychometrically validate the Nigerian Hausa Version of Örebro Musculoskeletal Pain Screening Questionnaire.
- To conduct an online survey to determine the knowledge and skills of Nigerian physiotherapist on the application of MET in the management of NSLBP.
- To evaluate the working mechanism of MET on the trunk muscle function by studying several muscular properties (recruitment, endurance, fatigability, flexibility) in chronic NSLBP.
- 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.
- 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.
- To evaluate the additional effect of MET relative to DSE on the study outcomes in the management of chronic NSLBP patients.
- 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
- To assess all outcomes at baseline, 6th week and 12th week of the study interventions.
- 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
- Chronic Non-specific Low Back Pain
- Being tested
- DSE plus MET group A, DSE alone group B, Standard Physiotherapy treatment group C
- Keywords
- MET, Low Back Pain, Stabilization exercises, Quality of Life, Functional disability
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSE plus MET group AProcedure or surgery
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 BProcedure or surgery
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 CProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| DSE plus MET (group A) | Experimental | 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%). Receives: Procedure: DSE plus MET group A |
| DSE only (group B) | Active comparator | 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. Receives: Procedure: DSE alone group B |
| Standard Physiotherapy Treatment (group C) | Active comparator | 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. Receives: Procedure: Standard Physiotherapy treatment group C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Outcomes Survey Short-Form-36 (SF-36)
Quality of Life (QoL) will be assessed with SF-36, The questionnaire is divided into 10 segments with a total of 36 questions. The segments involve Demography, General Health, Limitation of Activities, Physical Health Problem, Emotional Health Problem, Social Activities, Pain, Energy and Emotion, Social Activities and General Health.
Measured: 6 month
Activity Limitation and Participation Restriction
Level of activity Limitation and Participation Restriction would be measured using Orebro Musculoskeletal Pain Screening Questionnaire.
Measured: 6 month
Secondary outcomes (10)
Basal Mass Index (Demographic data)
Using formula; Body weight/Height square.
Measured: Once
Skin fold thickness for percentage body fat (Demographic data)
Skin fold calliper would be used to measure participants skin fold thickness
Measured: Once
Transverse abdominus muscles contraction rate
Pressure biofeedback unit
Measured: 6 months
Level of pain perception
Level of Pain Perception would be measured using pain numeric rating scale, it has a scale of 0-10-mm (0 means no Pain, 1-3 means mild pain, 4-7 means moderate pain and 8-10 means severe pain) and the minimally important change for the visual analog scale is 2 (using a 0-10 self-report scale). The patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours. The average of the 3 scores will represent patient's level of pain perception.
Measured: 6 months
Functional Disability
Level of Functional Disabilities of Participant resulting from CMLBP would be measured using Oswestry disability Index
Measured: 6 months
Spine range of motion
Inclinometer would be used to measure trunk range of motion
Measured: 6 months
Trunk extension endurance test
Biering-sorensen test
Measured: 6 months
Trunk flexion endurance test
McGill's torso battery test
Measured: 6 months
Trunk side flexion endurance test
McGill's torso battery test
Measured: 6 months
Global Rating of Change Scale (GROC)
This scale will be used to evaluate the satisfaction of the participant with the study intervention in term of improvement on symptoms.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 Jan 2019
- Primary completion14 Oct 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Chronic Non-specific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of KwaZulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usman Ahmed, University of KwaZulu
- Investigators
- USMAN ABBA AHMED, MASTERS, Principal investigator, University of KwaZuluMaharaj S Sonill, PhD, Study chair, University of KwaZuluNadasan N Thaya, PhD, Study director, University of KwaZulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449810
- Sponsor's protocol ID
- 217077488
- Acronym
- MET
- Status last verified
- Jul 2021
- First submitted
- 22 Feb 2018
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not yet decided whether to share IPD, but we will when we find it convenient
Publications
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.
PubMed 16777886Manusov EG. Evaluation and diagnosis of low back pain. Prim Care. 2012 Sep;39(3):471-9. doi: 10.1016/j.pop.2012.06.003.
PubMed 22958556Balague 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.
PubMed 21982256Hoy 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.
PubMed 22231424Louw 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.
PubMed 17976240Omokhodion FO. Low back pain in an urban population in Southwest Nigeria. Trop Doct. 2004 Jan;34(1):17-20. doi: 10.1177/004947550403400107.
PubMed 14959964Sikiru 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.
PubMed 20000059Cohen SP, Argoff CE, Carragee EJ. Management of low back pain. BMJ. 2008 Dec 22;337:a2718. doi: 10.1136/bmj.a2718. No abstract available.
PubMed 19103627Martell 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.
PubMed 17227935Mitchell, 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.
PubMed 25723574Marshall 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.
PubMed 15706550Hodges 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.
PubMed 12914264Charan 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.
PubMed 24049221Delitto 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.
PubMed 22466247
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Muscles Energy Technique on Quality of Life and Trunk Muscles Functions in Patients With Chronic Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT03449810
- Acronym / sponsor ID
- MET / 217077488
- Conditions
- Chronic Non-specific Low Back Pain
- Keywords
- MET, Low Back Pain, Stabilization exercises, Quality of Life, Functional disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of KwaZuluUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 14 Oct 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- To conduct a systematic review (scoping) of the literature on the effectiveness of MET in the management NSLBP.
- To cross-culturally adapt and psychometrically validate the Nigerian Hausa Version of Örebro Musculoskeletal Pain Screening Questionnaire.
- To conduct an online survey to determine the knowledge and skills of Nigerian physiotherapist on the application of MET in the management of NSLBP.
- To evaluate the working mechanism of MET on the trunk muscle function by studying several muscular properties (recruitment, endurance, fatigability, flexibility) in chronic NSLBP.
- 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.
- 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.
- To evaluate the additional effect of MET relative to DSE on the study outcomes in the management of chronic NSLBP patients.
- 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
- To assess all outcomes at baseline, 6th week and 12th week of the study interventions.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| DSE plus MET (group A) | Experimental | Procedure: DSE plus MET group AThe 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 only (group B) | Active comparator | Procedure: DSE alone group BThe 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. |
| Standard Physiotherapy Treatment (group C) | Active comparator | Procedure: Standard Physiotherapy treatment group CThis 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. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- NSLBP history of about or more than 3 months and associated with referred lower extremity pain; pain in the lumbopelvic region;
- Lumbar hypomobility; mobility deficits of the thorax and hip regions;
- LBP not of specific origin diagnosed by a physician (due to fracture, tumours, malignancy, ankyloses, infections, and pregnancy);
- Diminished trunk or pelvic region muscle strength and endurance;
- Movement coordination impairments while performing community/work-related recreational or occupational activities.
Key exclusion criteria (5 listed)
- Chronic NSLBP with radiating pain due to nerve root involvement in physical examination.
- Patients using immunosuppression or steroid medication.
- Patients with persistent severe pain.
- Patients with spinal deformities.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSE plus MET group AThe 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. | Procedure or surgery | DSE plus MET (group A) |
| DSE alone group BThe 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. | Procedure or surgery | DSE only (group B) |
| Standard Physiotherapy treatment group CIn 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. | Procedure or surgery | Standard Physiotherapy Treatment (group C) |
Primary outcome
Medical Outcomes Survey Short-Form-36 (SF-36)
Time frame: 6 month
Quality of Life (QoL) will be assessed with SF-36, The questionnaire is divided into 10 segments with a total of 36 questions. The segments involve Demography, General Health, Limitation of Activities, Physical Health Problem, Emotional Health Problem, Social Activities, Pain, Energy and Emotion, Social Activities and General Health.
Activity Limitation and Participation Restriction
Time frame: 6 month
Level of activity Limitation and Participation Restriction would be measured using Orebro Musculoskeletal Pain Screening Questionnaire.
10 secondary outcomes
Basal Mass Index (Demographic data)
Time frame: Once
Skin fold thickness for percentage body fat (Demographic data)
Time frame: Once
Transverse abdominus muscles contraction rate
Time frame: 6 months
Level of pain perception
Time frame: 6 months
Functional Disability
Time frame: 6 months
Spine range of motion
Time frame: 6 months
Trunk extension endurance test
Time frame: 6 months
Trunk flexion endurance test
Time frame: 6 months
Trunk side flexion endurance test
Time frame: 6 months
Global Rating of Change Scale (GROC)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Background: PubMed 16777886Koes 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.
- Background: PubMed 22958556Manusov EG. Evaluation and diagnosis of low back pain. Prim Care. 2012 Sep;39(3):471-9. doi: 10.1016/j.pop.2012.06.003.
- Background: PubMed 21982256Balague 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.
- Background: PubMed 22231424Hoy 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.
- Background: PubMed 17976240Louw 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.
- Background: PubMed 14959964Omokhodion FO. Low back pain in an urban population in Southwest Nigeria. Trop Doct. 2004 Jan;34(1):17-20. doi: 10.1177/004947550403400107.
- Background: PubMed 20000059Sikiru 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.
- Background: PubMed 19103627Cohen SP, Argoff CE, Carragee EJ. Management of low back pain. BMJ. 2008 Dec 22;337:a2718. doi: 10.1136/bmj.a2718. No abstract available.
- Background: PubMed 17227935Martell 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.
- BackgroundMitchell, F. L., & Mitchell, P. K. G. (1999). The muscle energy manual, 4196(517), 48826.
- Background: PubMed 25723574Franke 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.
- Background: PubMed 15706550Marshall 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.
- Balagué, F., Mannion, A. F., Pellisé, F., \& Cedraschi, C. (2012). Non-specific low back pain.Link provided by the sponsor.
- Louw QA, Morris LD, Grimmer-Somers K. The prevalence of low back pain in Africa: a systematic reviewLink provided by the sponsor.
- Omokhodion FO. Low back pain in an urban population in Southwest NigeriaLink provided by the sponsor.
- Sikiru, L., \& Shmaila, H. (2009). Prevalence and risk factors of low back pain among nurses in Africa: Nigerian and Ethiopian specialized hospitals survey studyLink provided by the sponsor.
- Cohen SP, Argoff CE, Carragee EJ. Management of low back pain.Link provided by the sponsor.
- Marshall, P. W., \& Murphy, B. A. (2005). Core stability exercises on and off a Swiss ball.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We have not yet decided whether to share IPD, but we will when we find it convenient
Related trials for Chronic Non-specific Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
Chronic Non-Specific Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
USMAN ABBA AHMED, MASTERS principal investigator
University of KwaZulu
Maharaj S Sonill, PhD study chair
University of KwaZulu
Nadasan N Thaya, PhD study director
University of KwaZulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DSE plus MET group A, DSE alone group B and Standard Physiotherapy treatment group C in people with Chronic Non-specific Low Back Pain, run by University of KwaZulu at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Outcomes Survey Short-Form-36 (SF-36) (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03449810, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.