Effects of Manual Therapy and Inclined Board Standing on Low Back Pain

Low Back Pain Clinical Trial

Official title:

Effects of Manual Therapy and Inclined Board Standing on Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05780593
• Other study ID #: AgileRehab
• Status: Completed
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: June 27, 2023

Study information

• Verified date: July 2023
• Source: Agile Institute of Rehabilitation Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To date, there have been limited clinical trials conducted to determine the effects of manual therapy combined with passive stretching and inclined board standing for treating low-back pain. This will be the first randomized controlled trial to evaluate the effects of these integrated interventions. The study aims to develop a new approach towards the cost-effective management of low-back pain, in line with the World Health Organization's (WHO) vision of maximizing health outcomes, preventing disability, and reducing the cost of care.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 27, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Manual Therapy
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.
• Inclined Board Standing
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.

Locations

Country	Name	City	State
Pakistan	Agile Institute of Rehabilitation Center	Bahawalpur	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Agile Institute of Rehabilitation Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (20)

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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. — View Citation

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. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NEUMERIC PAIN RATING SCALE (NPRS)	Changes from baseline numeric pain rating scale is a scale for pain starting from 0-10.	03 Months
Secondary	Oswestry-Disability-Index (ODI)	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.	03 Months
Secondary	Short-form-12 questionnaire (SF-12)	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).	03 Months