Effect of dynamic stabilisation exercise therapy enhanced with muscles energy technique on some selected patients outcomes and trunk muscles function in patients with chronic non-specific low back pain: a study protocol

Abstract

Background

Non-specific low back pain (NSLBP) is a common musculoskeletal condition causing functional disability and affecting the quality of life. Exercise therapy especially Dynamic Stabilisation Exercises (DSE) and Muscle Energy Techniques (MET) are frequently used in the treatment of NSLBP. However there are some inconsistencies with the use of DSE and the physiological mechanisms underlying the therapeutic effects of MET are currently unclear, and a review of literature on these interventions recommend further research. Therefore this study was designed to determine the effect of DSE and MET for the management of patients with NSLBP.

Methods

This study will involve 141 participants with chronic NSLBP. They will be randomised into three groups: two intervention groups i.e. DSE plus MET group, DSE alone and control (standard physiotherapy treatment). Outcomes that include trunk range of motion, Transverse Abdominus contraction rate, trunk muscles endurance, level of pain perception, quality of life, functional disability, activity limitation and participation restrictions will be assessed at baseline, 6th and 12th week of intervention, however, while follow-up assessment at 3-months after the intervention. Data will be analysed using descriptive statistics and inferential statistics of repeated ANOVA; P < 0.05.

Discussion

The study outcome will determine the combined effect of DSE plus MET on trunk muscles functions, level of pain perception, quality of life, functional disability, activity limitations and participation restrictions in patients with chronic NSLBP.

Trial Registration

www.ClinicalTrials.gov: NCT03449810

Keywords:

• Non-specific low back pain
• muscle energy technique
• dynamic stabilisation exercises
• ICF model
• functional disability

Acknowledgements

Prof. Dr Jessica Van Oosterwijck (PhD) is a post-doctoral research fellow funded by the Research Foundation–Flanders (FWO) [12L5619N and 12L5616N]. We would like to appreciate all the physiotherapists and medical doctors for their contribution to the success of the study and then, most importantly, the participants for their voluntary participation in the study. Our profound appreciation goes to Dr Bashir Kaka of Bayero University Kano for his professional advice in writing and making necessary corrections to this manuscript, also Mrs Oludokun Sharifat and Mr Anas Musa are appreciated for their editorial assistance.

Access to protocol

https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0007T62&selectaction=Edit&uid=U0003ZHG&ts=2&cx=-lh4gd5. The protocol was registered on 2nd Feb 2018 with identifier number NCT03449810 and the trial organisation name is UKwaZulu.

Ethical considerations and consent to participate

This study has been approved by the Biomedical Research Ethics Committee of the University of KwaZulu Natal (South Africa) (Ethics Number: BFC198/18) and by the Human Research Ethics Committee of Rasheed Shekoni Specialist Hospital (RSSH) (RSSH/GEN/226/V.II/7) and the Federal Medical Centre, Birnin-Kudu (FMC BKD) (No number, but evidence if requested can be provided), Nigeria. The study has been registered with ClinicalTrial.gov with the following registration number: NCT3449810. A written and signed informed consent will be obtained from all recruited participants for the study by a third party who is independent and not part of the core study team; the consent form is designed by the Biomedical Research Ethics Committee of University of KwaZulu-Natal (BREC) according to the WMA Helsinki declaration and good clinical practice (GCP).

During the conduct of this trial, the PI will communicate in writing to the RECs in the event on the need to modify or amend the protocol especially inclusion or exclusion criteria of the study.

Disclosure statement

The authors declared that they have no competing interests.

Author contributions

AUA developed the idea for the study; AUA, TN and MSS developed the title and all contributed to the study design. All authors were involved in designing the MET procedure and the selection of outcome measures for the study. AUA was responsible for drafting the initial manuscript. JVO helped with editing and critical review of the manuscript to add value to its intellectual content and all authors read, critically revised and approved the final version of the manuscript.

Data availability

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. However, the findings from the study would be made available to participating researchers as required by law.

Additional information

Funding

The study is funded by the College of Health Science of the University of KwaZulu-Natal (internal funding). The institution has no interest or role in the design of the study, writing the manuscript, collection and analysis of data. No external funding is received from any source for the study.