NCT06890845

Brief Summary

The aim of this study was to determine the significance of the impact of external factors (self-evaluation of the subjects) and internal factors, including the range of motion in the spine and hip joints, trunk muscle endurance and body posture of tennis players, on the occurrence and severity of low back pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
Last Updated

March 24, 2025

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

March 17, 2025

Last Update Submit

March 17, 2025

Conditions

Keywords

low back pain, tennis, ROM, muscle endurance, posture

Outcome Measures

Primary Outcomes (5)

  • Hip range of motion

    The hip range of motion was measured using a digital inclinometer. During hip rotation measurement, the subject lay prone with the pelvis stabilized by a strap. The tested hip was in a neutral position with the knee flexed to 90 degrees. The inclinometer was zeroed along the tibial axis when the tibial plateau was parallel to the ground. The range of motion was the angular difference between the initial and final positions. For flexion, the subject lay supine with the non-tested lower limb stabilized. The inclinometer was zeroed parallel to the ground. The final position was where the thigh could no longer move further into flexion. For extension, the subject .lay supine with the pelvis at the edge of the table. The subject maximally flexed both hips. The subject held the non-tested lower limb with both hands. On the tested side, the lower limb hung freely off the table. The inclinometer was zeroed on a surface parallel to the ground, and in the final position of the test.

    Baseline

  • Spine range of motion

    The measurement was conducted using a Baseline bubble inclinometer. For flexion, the patient stood in a relaxed position. The spinous processes of Th12 and S1 were palpated and marked. The inclinometer was zeroed at Th12, and the patient executed a full forward bend. The same was repeated at S1. The lumbar flexion range was the difference between readings at Th12 and S1. For extension, the patient also stood relaxed. Before measuring, the patient performed three maximum lumbar extensions. The inclinometer was zeroed at Th12, and the patient executed a maximum extension. The same procedure was repeated at S1. The lumbar extension range was the difference between readings at Th12 and S1. For lateral trunk flexion, the measurement was the distance between a point on the lateral thigh, where the tip of the third finger reached in a relaxed standing position, and a point on the thigh/shin after performing maximum lateral flexion.

    Baseline

  • Modified sit and reach test

    To perform the test, the subject sat on the examination table in such a way that one lower limb rested on the floor with the knee flexed at 90 degrees, while the other limb was placed on the table with the knee joint extended. The subject positioned their hands in front of them, thumbs joined and palms facing down. With elbows fully extended, the subject reached as far forward as possible, placing their hands on the table. The distance from the tip of the third finger to the heel line was measured. Positive results indicated that the tip of the third finger extended beyond the heel line, while negative results indicated that it was positioned before the heel line.

    Baseline

  • Body posture

    Posture assessment was conducted using the Diers Formetric 4D system, a non-invasive method with proven accuracy and reproducibility. This system employs surface topography for three-dimensional mapping of the subject's torso. The measurement followed the manufacturer's methodology. The subject stood 2 meters from the projector and camera, with foot placement marked on the treadmill. The back and neck were exposed, and undergarments adjusted to reveal the upper gluteal cleft. The subject assumed a relaxed standing position without posture correction. The examiner adjusted the projector height so that the central reference stripe aligned with the lower angle of the scapula. The device performed 12 scans in 6 seconds (2 Hz). The Diers software analyzed approximately 50,000 points on the subject's back, presenting a three-dimensional model of the spine with posture parameters.

    Baseline

  • Trunk muscle endurance

    The protocol for assessing trunk muscle endurance was based on the McGill et al. (1999) method. \[McGill, S. M., Childs, A., \& Liebenson, C. (1999). Endurance times for low back stabilization exercises: Clinical targets for testing and training from a normal database. Archives of Physical Medicine and Rehabilitation, 80(8), 941-944. https://doi.org/10.1016/s0003-9993(99)90087-4\]

    Baseline

Secondary Outcomes (3)

  • Oswestry Disability Index

    Baseline

  • Custom survey for individuals not playing tennis

    Baseline

  • Custom survey for tennis players

    Baseline

Study Arms (3)

Study Group (SG)

Women and men amateur tennis players with LBP

Comparison Group I (CGI)

Women and men amateur tennis players without LBP

Comparison Group II (CGII)

Physically active women and men not engaged in asymmetric sports without LBP

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Participants were recruited through announcements in tennis clubs, on internet portals, and on social media platforms within groups for amateur tennis players.

You may qualify if:

  • provided written consent to participate in the study
  • For Study Group:
  • playing tennis at least 3 times per week for the past 2 years
  • experiencing back pain in the last 6 months that prevented playing tennis
  • For Comprarison Group I:
  • playing tennis at least 3 times per week for the past 2 years
  • no lower back pain (confirmed via survey) in the last 6 months that would have prevented playing tennis
  • For Comparison Group II:
  • no lower back pain (confirmed via survey)
  • regular physical activity at least 3 times a week
  • no participation in asymmetrical sports

You may not qualify if:

  • lack of written consent to participate in the study,
  • history of surgical procedures involving the spine or torso,
  • severe musculoskeletal pathologies in the medical history, such as previous cancers in the torso area, vertebral fractures, structural scoliosis,
  • inability to assume the required test positions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mirai Clinic

Warsaw, 01-126, Poland

Location

Related Publications (2)

  • Avman MA, Osmotherly PG, Snodgrass S, Rivett DA. Is there an association between hip range of motion and nonspecific low back pain? A systematic review. Musculoskelet Sci Pract. 2019 Jul;42:38-51. doi: 10.1016/j.msksp.2019.03.002. Epub 2019 Mar 30.

    PMID: 31030110BACKGROUND
  • Chun SW, Lim CY, Kim K, Hwang J, Chung SG. The relationships between low back pain and lumbar lordosis: a systematic review and meta-analysis. Spine J. 2017 Aug;17(8):1180-1191. doi: 10.1016/j.spinee.2017.04.034. Epub 2017 May 2.

    PMID: 28476690BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 24, 2025

Study Start

April 1, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

March 24, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations