The Effects of Combined Lumbar Traction and Repeated Back Extension Exercise on H-Reflex, Pain, and Disability in Patients With Lumbosacral Radiculopathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Soleus H-reflex latency
Study Overview
Brief Summary
The aim of the study is to investigate the effect of performing combined lumbar traction and repeated back extension exercise (McKenzie) on soleus H-reflex, pain, and disability in patients with lumbosacral radiculopathy. The main question that it aims to answer is:
Does the combination of lumbar traction and back extension exercise (McKenzie) improves soleus H-reflex, pain, and function in patient with lumbosacral radiculopathy? participants will be randomized into 2 groups: one group will include repeated back extension exercise (McKenzie Approach) without mechanical traction and the other group will include the same but in combination with mechanical traction.
Detailed Description
Repeated back extension exercises as described by McKenzie from prone position has been widely suggested for patients with lumbosacral radiculopathy (LSR). It has been reported to decrease radicular symptoms which could be due to the decompression effect of this exercise on the compromised nerve root. Moreover, mechanical traction have a debatable effect on lumbosacral patients with little evidence that supports its effectiveness. Thus, the investigators hypothesize that performing a combination of lumbar traction and repeated back extension exercise will improve the soleus H-reflex, pain, and function of lumbosacral radiculopathy patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with chronic unilateral lumbosacral radiculopathy (more than 3 months duration)
- •Age:35- 60 years
- •Both male and female
- •People with L5-S1 postero-lateral disc herniation or protrusion.
- •people with positive straight leg raise
Exclusion Criteria
- •Subjects with lumbosacral Surgery.
- •Subjects with stenosis or scoliosis.
- •Subjects with cardiac problem or cancer.
- •Subjects with peripheral neuropathy.
- •Subjects with upper motor neuron injury.
Arms & Interventions
repeated back extension exercise (McKenzie)
Repeated back extension exercise as described by McKenzie in prone position was performed of three sets of ten repetitions with one minute rest between the sets. The patient was asked to reach the maximum extension possible in all attempts and maintain this position for one second. The intervention was done 3 times per week for 6 weeks.
Intervention: Repeated back extension exercise (McKenzie) (Other)
Combined mechanical lumbar traction and repeated back extension exercise (McKenzie)
Participants allocated to mechanical lumbar traction received the McKenzie approach described above in combination with mechanical lumbar traction. The traction was applied using a 3D ActiveTrac table which is a motorized split table. Participants were placed in prone position and static traction was applied for 15 minutes at an intensity of 40% to 60% of the participant's body weight. At the end of traction intervention, participants continued with the McKenzie repeated back extension exercise intervention. The intervention was done 3 times per week for 6 weeks.
Intervention: Repeated back extension exercise (McKenzie) (Other)
Combined mechanical lumbar traction and repeated back extension exercise (McKenzie)
Participants allocated to mechanical lumbar traction received the McKenzie approach described above in combination with mechanical lumbar traction. The traction was applied using a 3D ActiveTrac table which is a motorized split table. Participants were placed in prone position and static traction was applied for 15 minutes at an intensity of 40% to 60% of the participant's body weight. At the end of traction intervention, participants continued with the McKenzie repeated back extension exercise intervention. The intervention was done 3 times per week for 6 weeks.
Intervention: Mechanical traction (Device)
Outcomes
Primary Outcomes
Soleus H-reflex latency
Time Frame: At baseline and 6 weeks
latency in milliseconds (ms)
Soleus H-reflex amplitude
Time Frame: At baseline and 6 weeks
amplitude in millivolts (mV)
Secondary Outcomes
- Numerical Pain Intensity Scale(At baseline and 6 weeks)
- Oswestry Disability Index (ODI)(At baseline and 6 weeks)
Investigators
Ahmed ElMelhat
Principal investigator
Cairo University