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Relative Stiffness of Lumbar Spine and Hamstrings Muscle Stretching

Primary Purpose

Back Pain, Instability Lumbar Spine, Muscle Tightness

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Lumbopelvic stiffening technique
Lumbopelvic relaxing technique
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring History of low back pain, Clinical lumbar instability, Stretching exercise

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Faculty of Physical Therapy, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lumbopelvic stiffening technique

Lumbopelvic relaxing technique

Arm Description

Hamstring muscle stretching with lumbopelvic stiffening technique.

Hamstrings muscle stretching with lumbopelvic relaxing technique.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Muscle length based on modified Thomas and Trendelenburg test.
Clinical tests will be performed at the baseline because they could be a potential confounding factor.
Abdominal and back muscle strength .
Abdominal and back muscle strengths will be measured by using a hand-held dynamometer. Clinical tests will be performed at the baseline because they could be a potential confounding factor.

Full Information

First Posted
December 19, 2018
Last Updated
May 31, 2019
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT03787979
Brief Title
Relative Stiffness of Lumbar Spine and Hamstrings Muscle Stretching
Official Title
Effect of Increased Relative Stiffness of Lumbar Spine on Hamstrings Muscle Stretching in Individuals With History of Low Back Pain Suspected to Have a Clinical Lumbar Instability
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 24, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

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
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.
Detailed Description
The participants between the age of 20 and 40 years with history of low back pain will be recruited from Mahidol University using a poster posted at Faculty of Physical Therapy. All participants will be explained the purposes, advantages, disadvantages and procedures of the study by the researcher. The participant will be asked to sign an informed consent if the participants are willing to participate in this study. After obtaining the written informed consent, the researcher, who works in musculoskeletal system including low back pain for 7 years and has received 3 training sessions on clinical observation of aberrant movement, will perform 2 clinical tests including clinical observation of aberrant movement patterns and passive straight leg raising test to identify clinical lumbar instability, and measure hamstrings muscle length using clinical motion analysis system. The researcher will also screen for exclusion criteria using a check list. For those who are qualified for the study, the participants will be asked to fill out the demographic data and physical activity questionnaire. The researcher will perform additional clinical examination including modified Thomas test, back extensor muscle strength test assessed by a handheld dynamometer, Trendelenburg's test and lumbar stability test. After clinical tests, lumbopelvic, pelvic, and lumbar range of motions during an active forward bend task will be measured by using the clinical motion analysis system. These outcome measures will be assessed for baseline (Pre-1). After baseline data collection, the participants will be divided into 2 groups; lumbopelvic stiffening group (LS) or lumbopelvic relaxing group (LR) by randomly generated code in a concealed envelope. The participants in LS group will stretch the hamstrings muscle in standing position with lumbopelvic stabilization. Fifteen percent of the body weight will be used to standardize stretching force. This force will be controlled by visual feedback from load cell. During stretching protocol, the participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. Researcher commands "during adjusting the bed up, please tense the lower 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. To ensure that participant correctly performs lumbopelvic stabilization, the researcher will palpate at ASIS and iliac crest to check pelvic motion during hamstrings muscle stretching. Pelvic motion indicates loss of lumbopelvic stabilization. Participant will be asked to re-perform another repetition. Our protocol is based on a previous study by DePino et al., 2000. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions. The investigators use 30 seconds because a systematic review suggests that 30 seconds is the most effective dose for hamstrings muscle stretching. For the participants in LR group, the participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. The researcher commands "During adjusting the bed up, please relax the lower 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. After the intervention, the participants will be reassessed for hamstrings muscle length test, lumbar motion, pelvic motion and total lumbopelvic motion (Post-1). Because this study uses a cross-over study design, participants will be asked to maintain the usual physical activity for 2 days as a wash-out period. Then, the participants will be re-assessed for baseline data (Pre-2), and cross-over to another stretching group (LS changes to LR, while LR changes to LS). After completion of intervention, the participants will be re-assessed for post-intervention (Post-2). These to determine the effectiveness of lumbopelvic stabilization during hamstrings stretching in standing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Instability Lumbar Spine, Muscle Tightness
Keywords
History of low back pain, Clinical lumbar instability, Stretching exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
The assessor and investigator will be blinded to the random order. This process will be handled by the research manager.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbopelvic stiffening technique
Arm Type
Experimental
Arm Description
Hamstring muscle stretching with lumbopelvic stiffening technique.
Arm Title
Lumbopelvic relaxing technique
Arm Type
Active Comparator
Arm Description
Hamstrings muscle stretching with lumbopelvic relaxing technique.
Intervention Type
Other
Intervention Name(s)
Lumbopelvic stiffening technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Lumbopelvic relaxing technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lumbar, pelvic, and lumbopelvic motions at baseline.
Description
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.
Time Frame
These data will be collected at baseline and immediately after intervention.
Title
Lumbar, pelvic, and lumbopelvic motions after intervention.
Description
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.
Time Frame
These data will be collected at immediately after intervention.
Title
Hamstrings muscle length at baseline.
Description
Clinical motion analysis system will be used to measure the angle of knee extension that represents hamstrings muscle length at pre- and post-intervention.
Time Frame
These data will be collected at baseline.
Title
Hamstrings muscle length after intervention.
Description
Clinical motion analysis system will be used to measure the angle of knee extension that represents hamstrings muscle length at pre- and post-intervention.
Time Frame
These data will be collected at immediately after intervention.
Secondary Outcome Measure Information:
Title
Muscle length based on modified Thomas and Trendelenburg test.
Description
Clinical tests will be performed at the baseline because they could be a potential confounding factor.
Time Frame
These data will be collected at baseline only.
Title
Abdominal and back muscle strength .
Description
Abdominal and back muscle strengths will be measured by using a hand-held dynamometer. Clinical tests will be performed at the baseline because they could be a potential confounding factor.
Time Frame
These data will be collected at baseline only.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peemongkon Wattananon, PhD
Organizational Affiliation
Faculty of Physical Therapy, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy, Mahidol University
City
Salaya
State/Province
Nakhon Pathom
ZIP/Postal Code
73170
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The IPD of this study will be shared upon official request.
IPD Sharing Time Frame
The supporting information will be sent upon official request.
IPD Sharing Access Criteria
Having an official written request.
Citations:
PubMed Identifier
16181938
Citation
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.
Results Reference
background
PubMed Identifier
29097026
Citation
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.
Results Reference
background
PubMed Identifier
26240711
Citation
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.
Results Reference
background
PubMed Identifier
32339943
Citation
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, Avon). 2020 May;75:104996. doi: 10.1016/j.clinbiomech.2020.104996. Epub 2020 Apr 20.
Results Reference
derived

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Relative Stiffness of Lumbar Spine and Hamstrings Muscle Stretching

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