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

NCT05995145 | Completed

• 1 other identifier: 14/03/04/2023
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 8-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.

Conditions

Low Back Pain

Keywords

exercise; treatment; spine; posture; students; pain; hamstring muscles

Outcome Measures

Primary Outcomes (4)

• 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.

  Change from Pre-Intervention (baseline) compared to Post-Intervention (8 weeks)

• 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.

  Change from Pre-Intervention (baseline) compared to Post-Intervention (8 weeks)

• 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).

  Change from Pre-Intervention (baseline) compared to Post-Intervention (8 weeks)

• 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).

  Completion of 8 week intervention

Secondary Outcomes (1)

• Flexibility of the hamstring

  Change from Pre-Intervention (baseline) compared to Post-Intervention (8 weeks)

Study Arms (2)

Experimental group

EXPERIMENTAL

The hamstring stretching exercises program will be conducted five times a week, 20 min per session, for 8 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.

Behavioral: Active hamstring flexibility exercises with hip flexion mobilization

Control group

NO INTERVENTION

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

Interventions

Active hamstring flexibility exercises with hip flexion mobilization BEHAVIORAL

8 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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Józef Piłsudski University of Physical Education: lead
• University of Tehran: collaborator

Study Sites (1)

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

Biała Podlaska, 21-500, Poland

Location

MeSH Terms

Conditions

Low Back Pain; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 29, 2023
• First Posted: August 16, 2023
• Study Start: December 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: February 12, 2024
• Last Updated: February 14, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)