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Relative Stiffness of Lumbar Spine and Hamstrings Muscle Stretching

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ClinicalTrials.gov Identifier: NCT03787979
Recruitment Status : Completed
First Posted : December 27, 2018
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Peemongkon Wattananon, Mahidol University

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.

Condition or disease Intervention/treatment Phase
Back Pain Instability Lumbar Spine Muscle Tightness Other: Lumbopelvic stiffening technique Other: Lumbopelvic relaxing technique Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Double (Investigator, Outcomes Assessor)
Masking Description: The assessor and investigator will be blinded to the random order. This process will be handled by the research manager.
Primary Purpose: Treatment
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
Actual Study Start Date : December 24, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Lumbopelvic stiffening technique
Hamstring muscle stretching with lumbopelvic stiffening technique.
Other: Lumbopelvic stiffening technique
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.

Other: Lumbopelvic relaxing 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.

Active Comparator: Lumbopelvic relaxing technique
Hamstrings muscle stretching with lumbopelvic relaxing technique.
Other: Lumbopelvic stiffening technique
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.

Other: Lumbopelvic relaxing 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.




Primary Outcome Measures :
  1. Lumbar, pelvic, and lumbopelvic motions at baseline. [ Time Frame: These data will be collected at baseline and immediately 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.

  2. Lumbar, pelvic, and lumbopelvic motions after intervention. [ Time Frame: These data will be collected at immediately 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.

  3. Hamstrings muscle length at baseline. [ Time Frame: These data will be collected 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.

  4. Hamstrings muscle length after intervention. [ Time Frame: These data will be collected at immediately 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 :
  1. Muscle length based on modified Thomas and Trendelenburg test. [ Time Frame: These data will be collected at baseline only. ]
    Clinical tests will be performed at the baseline because they could be a potential confounding factor.

  2. Abdominal and back muscle strength . [ Time Frame: These data will be collected at baseline only. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787979


Locations
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Thailand
Faculty of Physical Therapy, Mahidol University
Salaya, Nakhon Pathom, Thailand, 73170
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Peemongkon Wattananon, PhD Faculty of Physical Therapy, Mahidol University

Publications:
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Responsible Party: Peemongkon Wattananon, Principal investigator, Mahidol University
ClinicalTrials.gov Identifier: NCT03787979     History of Changes
Other Study ID Numbers: 2018/200.1010
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The IPD of this study will be shared upon official request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The supporting information will be sent upon official request.
Access Criteria: Having an official written request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peemongkon Wattananon, Mahidol University:
History of low back pain
Clinical lumbar instability
Stretching exercise

Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms