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

Not Applicable

Completed

• Conditions: Lumbar Spinal Stenosis
• Interventions: Other: Physical therapy intervention

• Registration Number: NCT03368638
• Lead Sponsor: Texas Tech University Health Sciences Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-29
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-11
• Study Start: 2018-01-01
• Primary Completion: 2019-04-22
• Study Completion: 2019-04-22
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Physical therapy intervention	-

Primary Outcome Measures

Name	Time	Method
Change in Time to First Symptoms	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
Change in Swiss Spinal Stenosis Questionnaire	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.
Change in Total Ambulation Time	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.
Change in Numeric Pain Rating Scale	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.

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Amarillo, Texas, United States