NCT03787979

Brief Summary

The purpose of this study is to investigate the effect of lumbopelvic stabilization on hamstrings muscle stretching in individuals with history of low back pain suspected to have a clinical lumbar instability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

December 19, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

December 24, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 27, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

June 3, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

December 19, 2018

Last Update Submit

May 31, 2019

Conditions

Keywords

History of low back painClinical lumbar instabilityStretching exercise

Outcome Measures

Primary Outcomes (4)

  • Lumbar, pelvic, and lumbopelvic motions at baseline.

    Clinical motion analysis system will be used to measure these segmental motions. This system is composed of triple axis accelerometers (MPU6050, China), data acquisition board (Arduino Uno R3, Italy), and a LabVIEW software version 2012 (National Instrument, USA). The system will be used to measure pre- and post-intervention of angle of lumbar, pelvic, and lumbopelvic motions through a custom LabVIEW program at 100 Hz.

    These data will be collected at baseline and immediately after intervention.

  • Lumbar, pelvic, and lumbopelvic motions after intervention.

    Clinical motion analysis system will be used to measure these segmental motions. This system is composed of triple axis accelerometers (MPU6050, China), data acquisition board (Arduino Uno R3, Italy), and a LabVIEW software version 2012 (National Instrument, USA). The system will be used to measure pre- and post-intervention of angle of lumbar, pelvic, and lumbopelvic motions through a custom LabVIEW program at 100 Hz.

    These data will be collected at immediately after intervention.

  • Hamstrings muscle length at baseline.

    Clinical motion analysis system will be used to measure the angle of knee extension that represents hamstrings muscle length at pre- and post-intervention.

    These data will be collected at baseline.

  • Hamstrings muscle length after intervention.

    Clinical motion analysis system will be used to measure the angle of knee extension that represents hamstrings muscle length at pre- and post-intervention.

    These data will be collected at immediately after intervention.

Secondary Outcomes (2)

  • Muscle length based on modified Thomas and Trendelenburg test.

    These data will be collected at baseline only.

  • Abdominal and back muscle strength .

    These data will be collected at baseline only.

Study Arms (2)

Lumbopelvic stiffening technique

EXPERIMENTAL

Hamstring muscle stretching with lumbopelvic stiffening technique.

Other: Lumbopelvic stiffening techniqueOther: Lumbopelvic relaxing technique

Lumbopelvic relaxing technique

ACTIVE COMPARATOR

Hamstrings muscle stretching with lumbopelvic relaxing technique.

Other: Lumbopelvic stiffening techniqueOther: Lumbopelvic relaxing technique

Interventions

Participants will stretch their hamstrings muscle in standing position with lumbopelvic stiffening technique. Fifteen percent of the body weight will be used to standardize stretching force. During stretching protocol, the participants will be instructed to face the hydraulic table with their hips square, maintain trunk straight up and look straight ahead. Researcher commands "during adjusting the bed up, please tense your back rigid". After that, hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions.

Lumbopelvic relaxing techniqueLumbopelvic stiffening technique

Participants will be instructed to face the hydraulic table with their hips square, maintain trunk straight up and look straight ahead. The researcher commands "During adjusting the bed up, please relax your back". The hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions.

Lumbopelvic relaxing techniqueLumbopelvic stiffening technique

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 20 and 40
  • A recurrent pattern of LBP at least two episodes that interfered with activities of daily living and/or required treatment
  • Presenting aberrant movement pattern during active forward bend test
  • Passive straight leg raising test (SLR) greater than 91 degrees
  • Having hamstrings muscle tightness of both legs (passive knee extension in supine with 90° hip flexion position greater than 20 degrees)

You may not qualify if:

  • Having a history of abdominal, back surgery and/or fracture.
  • Having any red flags, such as infection, tumor, fracture, radicular syndrome, or inflammatory.
  • Pregnancy or having menstruation.
  • Having spinal deformities, such as scoliosis.
  • Having neurological, musculoskeletal or cardiopulmonary diseases.
  • Previously receiving physical therapy intervention involving in motor control training.
  • Taking muscle relaxant medication.
  • Having hip joint stiffness or pain
  • Having positive Trendelenburg's sign.
  • Currently having routine vigorous exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

Related Publications (4)

  • Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.

    PMID: 16181938BACKGROUND
  • Sahrmann S, Azevedo DC, Dillen LV. Diagnosis and treatment of movement system impairment syndromes. Braz J Phys Ther. 2017 Nov-Dec;21(6):391-399. doi: 10.1016/j.bjpt.2017.08.001. Epub 2017 Sep 27.

    PMID: 29097026BACKGROUND
  • Jandre Reis FJ, Macedo AR. Influence of Hamstring Tightness in Pelvic, Lumbar and Trunk Range of Motion in Low Back Pain and Asymptomatic Volunteers during Forward Bending. Asian Spine J. 2015 Aug;9(4):535-40. doi: 10.4184/asj.2015.9.4.535. Epub 2015 Jul 28.

    PMID: 26240711BACKGROUND
  • Wattananon P, Prasertkul W, Sakulsriprasert P, Laskin JJ. Effect of increased relative stiffness of the lumbar spine on hamstring muscle stretching in individuals with a history of low back pain suspected to have a clinical lumbar instability: A randomized crossover design. Clin Biomech (Bristol). 2020 May;75:104996. doi: 10.1016/j.clinbiomech.2020.104996. Epub 2020 Apr 20.

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peemongkon Wattananon, PhD

    Faculty of Physical Therapy, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The assessor and investigator will be blinded to the random order. This process will be handled by the research manager.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Participants will be randomly assigned to either stretching exercise with lumbopelvic stiffening technique or lumbopelvic relaxing technique. They will be provided a 2-day wash-out period. Then, participants will cross-over to another technique.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 19, 2018

First Posted

December 27, 2018

Study Start

December 24, 2018

Primary Completion

April 30, 2019

Study Completion

May 30, 2019

Last Updated

June 3, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

The IPD of this study will be shared upon official request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The supporting information will be sent upon official request.
Access Criteria
Having an official written request.

Locations