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

NCT03368638 | Completed

• 1 other identifier: A17-4019
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis

Keywords

Degenerative lumbar spinal stenosis; Neural mobilization; Hip extension mobilization; Case series; Neurogenic claudication

Outcome Measures

Primary Outcomes (4)

• Change in Swiss Spinal Stenosis Questionnaire

  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.

  Baseline, 3-6 weeks, 3-6 months

• Change in Numeric Pain Rating Scale

  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.

  Baseline, 3-6 weeks, 3-6 months

• Change in Total Ambulation Time

  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.

  Baseline, 3-6 weeks

• Change in Time to First Symptoms

  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

  Baseline, 3-6 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Other: Physical therapy intervention

Interventions

Physical therapy intervention OTHER

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

Intervention

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Amarillo, Texas, 79109, United States

Location

Related Publications (36)

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MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Reid D Gehring, DPT

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Jean-Michel Brismee, ScD

  Texas Tech University Health Sciences Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case Series

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 11, 2017
• Study Start: January 1, 2018
• Primary Completion: April 22, 2019
• Study Completion: April 22, 2019
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)