- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05780593
Effects of Manual Therapy and Inclined Board Standing on Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Manual therapy is a sub-type of physical therapy that uses hands-on maneuver to diagnose and treat musculoskeletal pain and dysfunction. Mobilization and manipulation are widely used for the management of low-back-pain (LBP), a common and debilitating condition that affects millions of people worldwide. The goal of manual therapy is to improve mobility, reduce pain and discomfort, and enhance functional capacity. Evidence is growing now a days that is in the direction of usage of manual therapy for the treatment of the lower back pain. Many studies have demonstrated the effectiveness of manual-therapy procedures such as spinal high velocity low amplitude thrust, low velocity and high intensity joint passive movement, and massage in alleviating pain and dysfunction and enhancing physical and mental functions in clinical cases with lower backache.
The prime purpose of this research aimed to investigate the relationship between the length of the tensor fasciae lata (TFL) and pelvic rotation during one-leg stance in healthy adults. 41 participants were assessed using a 3-dimensional motion analyzer, and their TFL length and hip rotation range of motion were measured. The results divided participants into two groups based on their pelvic rotation during one-leg stance. Although there was no significant difference in TFL length between the two groups, the study suggests that pelvic instability may cause trunk instability during one-leg stance.
Another study looked at static balance in three different standing positions with and without a foam surface. It found that standing over slanted surfaces increased postural unsteadiness, and that dorsiflexed ankles over a foam surface created more postural instability.
To create a human-like biped posture, a study created a Neural Controllable (NC) model to represent a human-like biped posture. The model generated physiologically reasonable muscle activations and captured the idea that individuals choose a low active stiffness level while standing to use less energy.
Another researcher reviewed the involvement of the "kinetic chain" in overhead athletes and applied it to clinical workout adjustments for the prevention and treatment of shoulder injuries. The study found that lower extremities, trunk, and scapular area all play a role in the formation of adequate terminal segment acceleration during overhead throwing and serving actions. The study suggests that traditional shoulder exercises should include scapular stabilizer and core musculature activation in addition to rotator cuff activation.
Research Gap:
Low-back-pain (LBP) is a Musculo-skeletal ailment that has a negative societal impact and is extremely common around the world, causing disability. LBP is one of the most common reasons people seek medical attention in the United States, along with neck pain, which is connected with the greatest healthcare expenses. Surgical patients are the most expensive per care episode, however the vast majority of lower backache management spending can be attributable to the substantially higher number of non-operative care episodes.
In 2021, Academy of Orthopedic Physical Therapy (AOPT) has published updated Clinical Practice Guidelines (CPG) for acute and chronic low-back-pain linked to the ICF model for physical therapists The updated Clinical Practice Guidelines (CPGs) for the treatment of lower back pain (LBP) recommend four interventional categories: exercise, manual and other-directed therapies, classification systems, and patient education. The guidelines were developed to be applicable globally and acknowledge that differences in factors such as healthcare systems, cultural norms, and social health determinants may impact the implementation of these recommendations. Physical therapists are the primary audience, but other stakeholders may also find the guidelines useful. The CPG update has identified knowledge gaps in the treatment of LBP and recommended further research using Single Level I RCT or Small-Sample Level II RCTs With Short Follow-up Times to develop better and cost-effective management approaches.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Bahāwalpur, Punjab, Pakistan, 63100
- Agile Institute of Rehabilitation Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants are capable of receiving the treatment thrice a week willingly for maximum of 60 minutes.
Persistent low back pain that has lasted more than three months with no evidence of improvement, with or without discomfort into the lower limbs.
Low back pain on Numerical Pain Rating scale of at least 2/10 and less or equal to 9/10. Age 18-65 years
Exclusion Criteria:
No informed consent Pregnancy reported by the patient Prior surgical history of spine Previously diagnosed inflammatory joint disease. Warning complaints diagnosed by therapist. These cases were referred for lab investigation.
Motor or sensory neurological signs Cases of low-back-pain are not compliant with the exercise program. Previously or currently indulge in the exercise plan or physical fitness plan
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group A
Manual mobilization of lumbosacral spine along with passive stretching of the hip abductors and 01 minute of inclined board standing for 03 times a day.
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After the baseline assessment, each intervention group will be given physical therapy treatment.
The group A will receive Manual Mobilization of the Lumbosacral Spine followed by passive stretching of the hip abductors of both sides of the body.
The patient then will be asked to stand on the inclined board for 01 minute with feet 3 to 4 inches apart hands placed on the wall at the level of shoulder joints.
After 01-minute patient will be asked to leave the inclined board.
The patient will be advised to do this 01-minute inclined board standing for three times a day at home.
All the patients in Group A will receive this treatment regime for two weeks.
Other Names:
The patients in Group B will be asked to stick to their medications if advised and stand on the inclined board for 01 minute.
Inclined boards will be provided to all patients and will be advised to follow the inclined standing for 01 minute for three times a day at home for two weeks.
After two weeks at the completion of intervention, they will be assessed through self-reporting questionnaires of the study.
Other Names:
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Experimental: Intervention Group B
Routine medications(if any) along with 01 minute of inclined board standing for 03 times a day.
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The patients in Group B will be asked to stick to their medications if advised and stand on the inclined board for 01 minute.
Inclined boards will be provided to all patients and will be advised to follow the inclined standing for 01 minute for three times a day at home for two weeks.
After two weeks at the completion of intervention, they will be assessed through self-reporting questionnaires of the study.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NEUMERIC PAIN RATING SCALE (NPRS)
Time Frame: 03 Months
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Changes from baseline numeric pain rating scale is a scale for pain starting from 0-10.
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03 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oswestry-Disability-Index (ODI)
Time Frame: 03 Months
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The ODI was established in English and has now been translated into over 40 languages.
It was developed to measure the low back pain and disability over time.
It consists of 10, with five-part sections.
At the last, score is calculated by dividing the obtained score by total (50) multiplied by 100.
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03 Months
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Short-form-12 questionnaire (SF-12)
Time Frame: 03 Months
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The Medical Outcomes Study (MOS), a multi-year study of patients with chronic illnesses, developed the 12-item Short Form Health Survey (SF-12).
The SF-12 is a general HRQoL assessment that assesses general health status in eight dimensions (physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health).
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03 Months
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Collaborators and Investigators
Investigators
- Principal Investigator: Muhammad Hafeez, Agile Institute of Rehabilitation Sciences
- Study Chair: Muhammad Hafeez, The Islamia University of Bahawalpur
Publications and helpful links
General Publications
- 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.
- Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
- Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.
- Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
- Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
- Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.
- Jenkinson C, Layte R, Jenkinson D, Lawrence K, Petersen S, Paice C, Stradling J. A shorter form health survey: can the SF-12 replicate results from the SF-36 in longitudinal studies? J Public Health Med. 1997 Jun;19(2):179-86. doi: 10.1093/oxfordjournals.pubmed.a024606.
- Bialosky JE, Beneciuk JM, Bishop MD, Coronado RA, Penza CW, Simon CB, George SZ. Unraveling the Mechanisms of Manual Therapy: Modeling an Approach. J Orthop Sports Phys Ther. 2018 Jan;48(1):8-18. doi: 10.2519/jospt.2018.7476. Epub 2017 Oct 15.
- Buchbinder R, van Tulder M, Oberg B, Costa LM, Woolf A, Schoene M, Croft P; Lancet Low Back Pain Series Working Group. Low back pain: a call for action. Lancet. 2018 Jun 9;391(10137):2384-2388. doi: 10.1016/S0140-6736(18)30488-4. Epub 2018 Mar 21.
- Chiarotto A, Deyo RA, Terwee CB, Boers M, Buchbinder R, Corbin TP, Costa LO, Foster NE, Grotle M, Koes BW, Kovacs FM, Lin CW, Maher CG, Pearson AM, Peul WC, Schoene ML, Turk DC, van Tulder MW, Ostelo RW. Core outcome domains for clinical trials in non-specific low back pain. Eur Spine J. 2015 Jun;24(6):1127-42. doi: 10.1007/s00586-015-3892-3. Epub 2015 Apr 5. Erratum In: Eur Spine J. 2015 Sep;24(9):2097.
- Adams, M. A., Bogduk, N., Burton, K., & Dolan, P. (2012). The Biomechanics of Back Pain-E-Book: Elsevier health sciences.
- Alwadani FA, Liang H, Aruin AS. Effects of Ankle Angular Position and Standing Surface on Postural Control of Upright Stance. Motor Control. 2020 Jan 23;24(2):291-303. doi: 10.1123/mc.2019-0079.
- Azevedo, R., Johnson, A., & Burkett, C. (2015). Does Training of Cognitive and Metacognitive Regulatory Processes Enhance Learning and Deployment of Processes with Hypermedia? Paper presented at the CogSci.
- Bishop MD, Torres-Cueco R, Gay CW, Lluch-Girbes E, Beneciuk JM, Bialosky JE. What effect can manual therapy have on a patient's pain experience? Pain Manag. 2015;5(6):455-64. doi: 10.2217/pmt.15.39. Epub 2015 Sep 24.
- Haddad C, Sacre H, Obeid S, Salameh P, Hallit S. Validation of the Arabic version of the "12-item short-form health survey" (SF-12) in a sample of Lebanese adults. Arch Public Health. 2021 Apr 23;79(1):56. doi: 10.1186/s13690-021-00579-3.
- Hall AM, Scurrey SR, Pike AE, Albury C, Richmond HL, Matthews J, Toomey E, Hayden JA, Etchegary H. Physician-reported barriers to using evidence-based recommendations for low back pain in clinical practice: a systematic review and synthesis of qualitative studies using the Theoretical Domains Framework. Implement Sci. 2019 May 7;14(1):49. doi: 10.1186/s13012-019-0884-4.
- Hultman G, Saraste H, Ohlsen H. Anthropometry, spinal canal width, and flexibility of the spine and hamstring muscles in 45-55-year-old men with and without low back pain. J Spinal Disord. 1992 Sep;5(3):245-53. doi: 10.1097/00002517-199209000-00001.
- Kim DH, Park JK, Jeong MK. Influences of posterior-located center of gravity on lumbar extension strength, balance, and lumbar lordosis in chronic low back pain. J Back Musculoskelet Rehabil. 2014;27(2):231-7. doi: 10.3233/BMR-130442.
- Negrini S, Giovannoni S, Minozzi S, Barneschi G, Bonaiuti D, Bussotti A, D'Arienzo M, Di Lorenzo N, Mannoni A, Mattioli S, Modena V, Padua L, Serafini F, Violante FS. Diagnostic therapeutic flow-charts for low back pain patients: the Italian clinical guidelines. Eura Medicophys. 2006 Jun;42(2):151-70. No abstract available.
- Vincent-Onabajo GO, Nweze E, Kachalla Gujba F, Ali Masta M, Usman Ali M, Alhaji Modu A, Umeonwuka C. Prevalence of Low Back Pain among Undergraduate Physiotherapy Students in Nigeria. Pain Res Treat. 2016;2016:1230384. doi: 10.1155/2016/1230384. Epub 2016 Feb 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AgileRehab
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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