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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Manual Therapy
Inclined Board Standing
Sponsored by
Agile Institute of Rehabilitation Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Manual Therapy, Passive Stretching, Inclined Board Standing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Agile Institute of Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention Group A

Intervention Group B

Arm Description

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.

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

Outcomes

Primary Outcome Measures

NEUMERIC PAIN RATING SCALE (NPRS)
Changes from baseline numeric pain rating scale is a scale for pain starting from 0-10.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
March 13, 2023
Last Updated
July 24, 2023
Sponsor
Agile Institute of Rehabilitation Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05780593
Brief Title
Effects of Manual Therapy and Inclined Board Standing on Low Back Pain
Official Title
Effects of Manual Therapy and Inclined Board Standing on Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
April 14, 2023 (Actual)
Study Completion Date
June 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agile Institute of Rehabilitation Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, Manual Therapy, Passive Stretching, Inclined Board Standing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention Group B
Arm Type
Experimental
Arm Description
Routine medications(if any) along with 01 minute of inclined board standing for 03 times a day.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Other Intervention Name(s)
Passive Stretching, Inclined Board Standing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Inclined Board Standing
Other Intervention Name(s)
Routine medications(if any)
Intervention Description
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.
Primary Outcome Measure Information:
Title
NEUMERIC PAIN RATING SCALE (NPRS)
Description
Changes from baseline numeric pain rating scale is a scale for pain starting from 0-10.
Time Frame
03 Months
Secondary Outcome Measure Information:
Title
Oswestry-Disability-Index (ODI)
Description
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.
Time Frame
03 Months
Title
Short-form-12 questionnaire (SF-12)
Description
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).
Time Frame
03 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Hafeez
Organizational Affiliation
Agile Institute of Rehabilitation Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Muhammad Hafeez
Organizational Affiliation
The Islamia University of Bahawalpur
Official's Role
Study Chair
Facility Information:
Facility Name
Agile Institute of Rehabilitation Center
City
Bahāwalpur
State/Province
Punjab
ZIP/Postal Code
63100
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Manual Therapy and Inclined Board Standing on Low Back Pain

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