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Completed

NCT Number: NCT03368638

Physical Therapy Treatments, Including Neural Mobilization and Hip/Back Stretches for People Between 50-89 With Lumbar Spinal Stenosis and Leg Pain Provoked by Walking

Aging of the back is common in the older people and can result in difficulties standing and walking. Conservative treatment is recommended before considering surgery. Some recommended exercises involve the use of expensive equipment. The present study plans to evaluate if specifically moving the nerves in the legs/back and improving flexibility of the hip and back can benefit patients. These exercises require no equipment, are simple to perform, and can provide patients a way to continue to perform these exercises at home. The purposes of this study are to (1) observe the benefit of a treatment program involving moving the nerves of the leg/back, stretching the legs and low back in patients with low back pain and difficulties walking; and (2) determine if benefits received remain at a 3-month follow-up.

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Key information

Age range

50 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University Health Sciences Center

Amarillo, Texas, 79109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged between 50-89 years old
  • Intermittent unilateral or bilateral leg pain occurring with walking and standing activities that is relieved only with sitting or by assuming flexed positions
  • Magnetic Resonance Imaging (MRI) confirmation of lumbar spinal stenosis
  • Leg symptoms greater than 4/10 and provoked within 15 minutes of walking

Exclusion criteria

  • Prior lumbar surgery
  • Spinal injection in last 6 weeks
  • Impaired walking tolerance due to factors other than neurogenic claudication
  • Inability to follow the rater's instructions
  • Any medical contra-indication for hip mobilizations in extension or flexion
  • Current medico-legal issues

Treatment and study plan

Physical therapy intervention

Other

Double knee to chest stretches, hip extension mobilization, neural mobilizations, home exercises program

Primary outcomes

  1. Change in Swiss Spinal Stenosis Questionnaire

    Time frame: Baseline, 3-6 weeks, 3-6 months

    The Swiss Spinal Stenosis Questionnaire is a condition specific measure used for subjects with lumbar spinal stenosis. The measure consists of three separate subscales: Symptom, Functional, Satisfaction. Each scale has five to seven items, with each item scored on a Likert response scale with four to five options. The subscale score is calculated as the unweighted mean of all answered items, with a range of scores for each subscale as follows: one to five for symptom severity, one to four for physical function, and one to four for satisfaction. Lower scores represent fewer symptoms, greater function, and greater satisfaction with the results of their treatment. The subscale scores will be assessed independently of each other.

  2. Change in Numeric Pain Rating Scale

    Time frame: Baseline, 3-6 weeks, 3-6 months

    The Numeric Pain Rating Scale is an objective measure for subjects to rate their pain. This measure uses an 11 point scale where "0" represents "no pain" and "10" represents "the worst imaginable pain". Subjects in this study will be asked to rate their average pain during walking activities during the past week. The NPRS is a valid measure that has been shown to have good test-retest reliability (ICC = 0.61) (Childs et al 2005). This measure has been used in previous studies examining subjects with degenerative LSS.

  3. Change in Total Ambulation Time

    Time frame: Baseline, 3-6 weeks

    Total Ambulation Time is an objective test to measure walking tolerance that has shown concordance correlation coefficient of 0.96 test-retest reliability in subjects with lumbar spinal stenosis (Deen et al 2000). This is a valid measure as it reproduces a subject's symptoms in the same manner as they are reproduced during daily life. Subjects will be asked to ambulate on a treadmill in a fully erect posture at a self-selected walking pace. Subjects will not be permitted to lean forward or hold onto handrails. Ambulation will be stopped at 15 minutes or when the subject reports a level of discomfort in their leg(s) that would cause them to stop walking in usual daily life situations (Deen et al 2000). The subject will be asked to remain standing for up to 15 seconds (if tolerated) in order to assess whether the leg symptoms can resolve in standing or if sitting is required. Longer walking times are considered an improvement in condition with this test.

  4. Change in Time to First Symptoms

    Time frame: Baseline, 3-6 weeks

    Time to First Symptoms is an objective test used to record the time it takes before the onset of leg symptoms during treadmill ambulation. This measure has shown concordance correlation coefficient of 0.98 for test-retest reliability in subjects with lumbar spinal stenosis (Deen et al 2000). It is a valid measure of leg symptoms onset during an ambulation activity, which is responsible for symptom onset in daily life. Subjects will ambulate on a treadmill in a fully erect posture. Subjects will ambulate at a self-selected comfortable walking pace and will not be permitted to lean forward or hold onto handrails. Subjects will be asked to report the moment of first onset of leg symptoms (unilateral or bilateral leg pain, fatigue, paresthesia, and/or tightness). Longer times to the onset of first symptoms are considered an improvement in condition with this test

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Official study title

Neural And Hip Mobilizations In Patients With Neurogenic Claudication Associated With Degenerative Lumbar Spinal Stenosis: A Case Series

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 11, 2017
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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