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Active Mobilization of Hamstring for Non-specific Low Back Pain and Musculoskeletal Discomfort During Prolonged Sitting

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Active hamstring flexibility exercises with hip flexion mobilization
Sponsored by
Józef Piłsudski University of Physical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring exercise, treatment, spine, posture, students, pain, hamstring muscles

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: students in Physical Education (18-25 years old) with non-specific LBP (defined as pain and discomfort localized below the costal margin and above the inferior gluteal folds), the pain of at least 3 months duration, without radiation to legs without a surgical history due to spinal problems didn't previously continue the hamstring stretches exercises with hamstring muscle shortness Exclusion Criteria: spinal pathology (eg, tumor, infection, fracture, inflammatory disease disc herniation and leg length discrepancy over 1cm pregnancy nerve root compromise previous spinal surgery major surgery scheduled during treatment or follow-up period presence of any contraindication to exercise medically verified chronic back disorde menstrual pain

Sites / Locations

  • Jozef Pilsudski University of Physical Education in Warsaw, Faculty of Physical Education and Heath in Biala PodlaskaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

The hamstring stretching exercises program will be conducted five times a week, 20 min per session, for 12 weeks. The exercises will be supervised by an experienced physiotherapist with five years of clinical experience. The intervention will be divided into two parts. The first part will include exercises with a massage foam roller. The second part will include exercises of active hamstring flexibility exercises with hip flexion mobilization and the development of the habit of correct hip flexion technique, protecting the lower spine.

Participants assigned to the control group will receive an self-care recommendations book.

Outcomes

Primary Outcome Measures

Pain Intensity
The Visual Analogue Scale (VAS) will be used to assess average pain intensity graded from 0 (no pain) up to 10 (unbearable pain). Mild pain or no pain will be defined as VAS 0-3, moderate pain as VAS 4-6, and severe pain as VAS 7-10. Participants will be asked to rate their maximum pain intensity from the last 3 months.
Functional Disability
The Revised Oswestry Low Back Pain Disability Index will be used to assess the level of functional disabilities of participants resulting from LBP. The questionnaire consists of 10 items related to different aspects of function regarding activities of daily living (ADL). Each item will be scored from 0 to 5, with higher values representing greater disability. The total score will be multiplied by 2 and expressed as a percentage.
Perceived musculoskeletal discomfort during prolonged sitting
The Borg CR-10 scale will be used to assess the perceived musculoskeletal discomfort during 1 hour of sitting named as prolonged sitting. The Borg CR-10 scale is presented in such a way that test subjects can indicate in which parts of the body feel discomfort (i.e. neck, shoulder, upper back, lower back, hip/thigh, and knee) and the degree of discomfort they feel (on a scale from 0 to 10, 0 being no discomfort and 10 being extremely uncomfortable).
The global perceived improvement
The Global Perceived Effect (GPE) will be used to assess the global perceived improvement. The investigator will ask the student to rate, on a numerical scale, how much their condition has improved or deteriorated since some predefined time point: 1 = completely recovered, 2 = much improved, 3 = slightly improved, 4 = not changed, 5 = slightly worsened, 6 = much worsened and 7 = worse than ever. These ratings will be dichotomized into "improved" (GPE scores 1-2) and "not improved" (GPE scores 3 to 7).

Secondary Outcome Measures

Flexibility of the hamstring
The flexibility of the hamstring will be assessed through the SLR.The SLR is a passive test performed unilaterally. The criterion score of hamstring extensibility will be the maximum angle (degree) read from the goniometer at the point of maximum hip flexion. Angles will be recorded to the nearest degree for each leg. Two trials will give for each leg and the average of the two trials on each side will use for subsequent analysis. A subject's hamstring muscles will be considered tight (in a shortened position) if there was an SLR of ≤70 degrees.

Full Information

First Posted
July 29, 2023
Last Updated
September 27, 2023
Sponsor
Józef Piłsudski University of Physical Education
Collaborators
University of Tehran
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1. Study Identification

Unique Protocol Identification Number
NCT05995145
Brief Title
Active Mobilization of Hamstring for Non-specific Low Back Pain and Musculoskeletal Discomfort During Prolonged Sitting
Official Title
A 12-week Randomized Controlled Trial of Active Mobilization of Hamstring for Non-specific Low Back Pain and Musculoskeletal Discomfort During Prolonged Sitting Among Young People: Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Józef Piłsudski University of Physical Education
Collaborators
University of Tehran

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
Hip flexion is a normal part of everyday functional activities, including walking and sitting. The length of the hamstring influences on movement of the pelvis during hip flexion, consequently influencing lumbar lordosis. In most activities, the hamstring muscles are active and it is necessary to keep them at normal length. Sitting posture is responsible for the loss of the natural curvature of the lumbar spine, because the hip flexion and pelvic extension flatten the lumbar vertebrae (i.e., lumbopelvic rhythm). Furthermore tightened hamstring increases posterior pelvic tilt and reduces lumbar lordosis, which can tend to low back pain (LBP). Stretching exercises play an important role in both the prevention and treatment of LBP. One important option will be exercise protocol which will combine the active hamstring flexibility exercises with hip flexion mobilization and the development of the habit of correct hip flexion technique, protecting the lower spine. The aim of this RCT is to present a protocol for evaluating the effect of 12-week active hamstring flexibility exercises with hip flexion mobilization in reducing LBP and perceived musculoskeletal discomfort during prolonged sitting in young adults with non-specific LBP.
Detailed Description
Background: Limited lower extremity muscle flexibility, such as hamstring, iliopsoas, quadriceps, and limited hip range of motion are risk factors for low back pain (LBP) in young people. LBP has increased by 49.8-50.7% over the last twenty years which highlighted the increase in the dominance of LBP especially among young people. Flexibility is an essential factor in physical fitness, which has a significant role in the functional development of the musculoskeletal system and the optimization of muscle work. To prevent pain or perceived musculoskeletal discomfort, various flexibility exercises including exercise stretches of the hamstring muscles have been recommended. Improving the hip flexion technique requires hip power and stability in the lumbar spine. In hamstring flexibility training, we should create an opportunity to practice movement and develop correct patterns using the hip flexion and extension pattern while maintaining the stability of the lumbar spine. Keeping the torso straight while working the hips and knees is one of the basic principles of protecting the spine in the lumbar region. Maintaining a neutral lower spine protects passive tissues and allows for better mobilization of the hips. Stretching exercises play an important role in both the prevention and treatment of LBP. One important option will be exercise protocol which will combine the active hamstring flexibility exercises with hip flexion mobilization and the development of the habit of correct hip flexion technique, protecting the lower spine. Objective: This randomized controlled trial aims to investigate the effect of a 12-week intervention involving active hamstring flexibility exercises with hip flexion mobilization on reducing low back pain (LBP) and perceived musculoskeletal discomfort during prolonged sitting in young adults with non-specific LBP. Methods: This will be a single-blind, randomized controlled trial with pre and post-intervention assessment. Participants were recruited from Physical Education Faculty students and randomly assigned to either the experimental group (hamstring stretching exercises) or the control group (no intervention). The hamstring stretching exercises group will be held five a week, 20 min per session for 12 weeks. The primary outcomes will be average pain intensity (Visual Analogue Scale, VAS), functional disability (Oswestry Disability Index), perceived musculoskeletal discomfort during prolonged sitting (Borg scale) , and the global perceived improvement (The Global Perceived Effect, 7-point Likert scale). Secondary outcome will be flexibility of the hamstring (SLR test). Expected outcomes: The findings of this study might provide information about a 12-week intervention involving active hamstring flexibility exercises with hip flexion mobilization on reduction of LBP and musculoskeletal discomfort during prolonged sitting in young adults. These results might highlight the importance of incorporating targeted flexibility exercises in the management of non-specific LBP, particularly in individuals with a sedentary lifestyle. Further research is warranted to explore the long-term effects and applicability of these interventions in larger populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
exercise, treatment, spine, posture, students, pain, hamstring muscles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The hamstring stretching exercises program will be conducted five times a week, 20 min per session, for 12 weeks. The exercises will be supervised by an experienced physiotherapist with five years of clinical experience. The intervention will be divided into two parts. The first part will include exercises with a massage foam roller. The second part will include exercises of active hamstring flexibility exercises with hip flexion mobilization and the development of the habit of correct hip flexion technique, protecting the lower spine.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants assigned to the control group will receive an self-care recommendations book.
Intervention Type
Behavioral
Intervention Name(s)
Active hamstring flexibility exercises with hip flexion mobilization
Intervention Description
12 weeks x 5 times per week for 20 min. In the experimental intervention, the exercise program will be based on participant education, home-based individual exercises, and regular group meetings for check-ups by a physiotherapist according to a precise set schedule.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
The Visual Analogue Scale (VAS) will be used to assess average pain intensity graded from 0 (no pain) up to 10 (unbearable pain). Mild pain or no pain will be defined as VAS 0-3, moderate pain as VAS 4-6, and severe pain as VAS 7-10. Participants will be asked to rate their maximum pain intensity from the last 3 months.
Time Frame
Change from Pre-Intervention (baseline) compared to Post-Intervention (12 weeks)
Title
Functional Disability
Description
The Revised Oswestry Low Back Pain Disability Index will be used to assess the level of functional disabilities of participants resulting from LBP. The questionnaire consists of 10 items related to different aspects of function regarding activities of daily living (ADL). Each item will be scored from 0 to 5, with higher values representing greater disability. The total score will be multiplied by 2 and expressed as a percentage.
Time Frame
Change from Pre-Intervention (baseline) compared to Post-Intervention (12 weeks)
Title
Perceived musculoskeletal discomfort during prolonged sitting
Description
The Borg CR-10 scale will be used to assess the perceived musculoskeletal discomfort during 1 hour of sitting named as prolonged sitting. The Borg CR-10 scale is presented in such a way that test subjects can indicate in which parts of the body feel discomfort (i.e. neck, shoulder, upper back, lower back, hip/thigh, and knee) and the degree of discomfort they feel (on a scale from 0 to 10, 0 being no discomfort and 10 being extremely uncomfortable).
Time Frame
Change from Pre-Intervention (baseline) compared to Post-Intervention (12 weeks)
Title
The global perceived improvement
Description
The Global Perceived Effect (GPE) will be used to assess the global perceived improvement. The investigator will ask the student to rate, on a numerical scale, how much their condition has improved or deteriorated since some predefined time point: 1 = completely recovered, 2 = much improved, 3 = slightly improved, 4 = not changed, 5 = slightly worsened, 6 = much worsened and 7 = worse than ever. These ratings will be dichotomized into "improved" (GPE scores 1-2) and "not improved" (GPE scores 3 to 7).
Time Frame
Completion of 12 week intervention
Secondary Outcome Measure Information:
Title
Flexibility of the hamstring
Description
The flexibility of the hamstring will be assessed through the SLR.The SLR is a passive test performed unilaterally. The criterion score of hamstring extensibility will be the maximum angle (degree) read from the goniometer at the point of maximum hip flexion. Angles will be recorded to the nearest degree for each leg. Two trials will give for each leg and the average of the two trials on each side will use for subsequent analysis. A subject's hamstring muscles will be considered tight (in a shortened position) if there was an SLR of ≤70 degrees.
Time Frame
Completion of 12 week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: students in Physical Education (18-25 years old) with non-specific LBP (defined as pain and discomfort localized below the costal margin and above the inferior gluteal folds), the pain of at least 3 months duration, without radiation to legs without a surgical history due to spinal problems didn't previously continue the hamstring stretches exercises with hamstring muscle shortness Exclusion Criteria: spinal pathology (eg, tumor, infection, fracture, inflammatory disease disc herniation and leg length discrepancy over 1cm pregnancy nerve root compromise previous spinal surgery major surgery scheduled during treatment or follow-up period presence of any contraindication to exercise medically verified chronic back disorde menstrual pain
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magdalena Plandowska, PhD
Phone
+48 83 3428800
Email
magdalena.plandowska@awf.edu.pl
Facility Information:
Facility Name
Jozef Pilsudski University of Physical Education in Warsaw, Faculty of Physical Education and Heath in Biala Podlaska
City
Biała Podlaska
ZIP/Postal Code
21-500
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena Plandowska, PhD
Phone
+48833428800
Email
magdalena.plandowska@awf.edu.pl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Active Mobilization of Hamstring for Non-specific Low Back Pain and Musculoskeletal Discomfort During Prolonged Sitting

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