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

Sponsor

Agile Institute of Rehabilitation Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05780593

Collaborator

(none)

Enrollment

Location

Arms

2.5

Anticipated Duration (Months)

17.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Other: Manual Therapy Other: Inclined Board Standing	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two arm parallel research involves two groups randomized into Interventional Group-A and Interventional Group-B. The unit of randomization will be Agile Institute of Rehabilitation Sciences. This study will use 2 (between groups: Effects of mobilization with passive stretching of lateral rotators along with inclined board standing vs Inclined board standing) ×3 (time: before vs. after vs. 4 weeks after follow-up) mixed design to measure the effects of mobilization, passive stretching of hip abductors and inclined board standing on low back patient.Two arm parallel research involves two groups randomized into Interventional Group-A and Interventional Group-B. The unit of randomization will be Agile Institute of Rehabilitation Sciences. This study will use 2 (between groups: Effects of mobilization with passive stretching of lateral rotators along with inclined board standing vs Inclined board standing) ×3 (time: before vs. after vs. 4 weeks after follow-up) mixed design to measure the effects of mobilization, passive stretching of hip abductors and inclined board standing on low back patient.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 22, 2023

Anticipated Primary Completion Date :

Apr 14, 2023

Anticipated Study Completion Date :

Jun 5, 2023

Arms and Interventions

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.	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 using Sustained Anterior Glide at facet joints and Sustained Medial Glide 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: Passive Stretching Inclined Board Standing Other: Inclined Board Standing The patients in Group B will be asked to stick to their medications if advised and stand for one minute on the inclined board for 01 minute. All the patients will be provided advised to follow this inclined standing for 01 minute 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: Routine medications(if any)
Experimental: Intervention Group B Routine medications(if any) along with 01 minute of inclined board standing for 03 times a day.	Other: Inclined Board Standing The patients in Group B will be asked to stick to their medications if advised and stand for one minute on the inclined board for 01 minute. All the patients will be provided advised to follow this inclined standing for 01 minute 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: Routine medications(if any)

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.

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 using Sustained Anterior Glide at facet joints and Sustained Medial Glide 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:

Passive Stretching

Inclined Board Standing

Other: Inclined Board Standing

The patients in Group B will be asked to stick to their medications if advised and stand for one minute on the inclined board for 01 minute. All the patients will be provided advised to follow this inclined standing for 01 minute 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:

Routine medications(if any)

Experimental: Intervention Group B

Routine medications(if any) along with 01 minute of inclined board standing for 03 times a day.

Other: Inclined Board Standing

Other Names:

Routine medications(if any)

Outcome Measures

Primary Outcome Measures

NEUMERIC PAIN RATING SCALE (NPRS) [03 Moths]
Changes from baseline numeric pain rating scale is a scale for pain starting from 0-10.
Oswestry-Disability-Index (ODI) [03 Months]
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.
Short-form-12 questionnaire (SF-12) [03 Months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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