Radiculopathy
Conditions
Keywords
Lumbosacral radiculopathy, peripheral sensitization, Neural mobilization, radicular LBP, slider, tensioner
Brief summary
The primary purpose of this study was to investigate the effects of slider and tensioner techniques on pain, hip and knee ROM in lumbosacral radiculopathy patients with peripheral sensitization. A secondary purpose was to evaluate the correlation between these outcomes measurements.
Detailed description
Study design: Double-blind case-control trial. Methods: Fifty-one male lumbosacral radiculopathy patients with peripheral sensitization, were divided into one of the three groups: slider, tensioner, and control. The primary outcome measurements were visual analog scale (VAS) for pain, hip range of motion (ROM) during SLR test, and knee flexion ROM during slump test. The measurements were taken at baseline, after 1st, 3rd, and 6th session. Statistical Analysis: A two-way mixed design analysis of variance (MANOVA) with post-hoc (Bonferonni Correction) was used to calculate the differences with Time (baseline, 1st,3rd,6th sessions) as a within-group factor and Group (control, slider, and tensioner) as a between-group factor. The effect size was calculated with Cohen's d. Pearson's correlation was used for correlation analysis.
Interventions
OTHERNeural mobilization exercises -Tensioner technique
Exercise aiming to lengthen the neural structure using more than one joint.
OTHERNeural mobilization exercises -Slider technique
Exercise aiming to slide/glide the neural structure using more than one joint.
OTHERTranscutaneous Electrical Nerve Stimulation (TENS)
Electrotherapy device aiming to decrease patient's symptoms.
Sponsors
Mohammed Al-Ghamdi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
both the examiner and the outcomes assessor where blinded to the participants groups. the primary investigator was also blind to the outcomes of each participant during the study period.
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with lumbosacral radiculopathy with dominant peripheral sensitization * patients with unilateral leg pain. * patient S-LANSS score \> 12, * negative sensory and motor examination. * positive neural tissue provocation tests (straight leg raising test, slump test). * adult. * pain duration of more than 3 months.
Exclusion criteria
* S-LANSS score ≥ 12, * motor or sensory deficits, * history of back or lower extremity surgeries, * bilateral referred pain, * patients with pacemakers, cardiovascular problems, epilepsy, active malignancy, dermatological conditions, and diminished pain sensation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | The measurements were taken at days 0,1,5,12 | Visual analog scale was used to measure pain intensity. This scale is a 10 cm line where patients chose from 0 to 10 (when 0 mean no pain and 10 mean maximum pain) |
| Hip Flexion Range of Motion (Symptomatic Side) | The measurements were taken at days 0,1,5,12 | Change in Hip flexion range of motion during straight leg raising (symptomatic side) |
| Knee Flexion Range of Motion (Symptomatic Side) | The measurements were taken at days 0,1,5,12 | Change in Knee flexion range of motion during slump (symptomatic side) |
| Hip Flexion Range of Motion (Asymptomatic Side) | The measurements were taken at days 0,1,5,12 | Change in Hip Flexion Range of Motion During Straight Leg Raising (Asymptomatic Side) |
| Knee Flexion Range of Motion (Asymptomatic Side) | The measurements were taken at days 0,1,5,12 | Change in Knee flexion range of motion during slump (Asymptomatic side) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group patients in this group had 6 session of Transcutaneous Electric Nerve Stimulation in 2 weeks.
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management | 17 |
| Tensioner Group patients in this group had 6 session of TENS combined with Neural mobilization exercises -Tensioner technique in 2 weeks.
Neural mobilization exercises -Tensioner technique: a maneuver was done to increase the tension by lengthening the neural structure
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management | 17 |
| Slider Group patients in this group had 6 session of TENS combined with Neural mobilization exercises -Slider technique in 2 weeks.
Neural mobilization exercises -Slider technique: maneuver that produces a sliding motion between the neural tissues and the surrounding structures
Transcutaneous Electric Nerve Stimulation: electric current produced by a device to stimulate the nerves for pain management | 17 |
| Total | 51 |
Baseline characteristics
| Characteristic | Control Group | Tensioner Group | Slider Group | Total |
|---|---|---|---|---|
| Age, Continuous | 40.24 years STANDARD_DEVIATION 9.49 | 33.53 years STANDARD_DEVIATION 8.64 | 36.82 years STANDARD_DEVIATION 8.01 | 36.86 years STANDARD_DEVIATION 8.99 |
| body mass insex | 27.08 Kg/m^2 STANDARD_DEVIATION 3.83 | 28.23 Kg/m^2 STANDARD_DEVIATION 6.04 | 28.19 Kg/m^2 STANDARD_DEVIATION 5.6 | 27.83 Kg/m^2 STANDARD_DEVIATION 5.16 |
| Pain | 5.63 Centimeters STANDARD_DEVIATION 1.75 | 5.09 Centimeters STANDARD_DEVIATION 1.95 | 5.05 Centimeters STANDARD_DEVIATION 2.15 | 5.26 Centimeters STANDARD_DEVIATION 1.93 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 17 Participants | 17 Participants | 17 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 | 0 / 17 |
Outcome results
Primary
Hip Flexion Range of Motion (Asymptomatic Side)
Change in Hip Flexion Range of Motion During Straight Leg Raising (Asymptomatic Side)
Time frame: The measurements were taken at days 0,1,5,12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Hip Flexion Range of Motion (Asymptomatic Side) | Baseline | 70.00 degrees | Standard Deviation 15.313 |
| Control Group | Hip Flexion Range of Motion (Asymptomatic Side) | After 1st Day | 69.41 degrees | Standard Deviation 17.044 |
| Control Group | Hip Flexion Range of Motion (Asymptomatic Side) | After 5th Day | 71.12 degrees | Standard Deviation 11.146 |
| Control Group | Hip Flexion Range of Motion (Asymptomatic Side) | After 12th Day | 73.06 degrees | Standard Deviation 12.92 |
| Slider Group | Hip Flexion Range of Motion (Asymptomatic Side) | After 12th Day | 74.88 degrees | Standard Deviation 19.251 |
| Slider Group | Hip Flexion Range of Motion (Asymptomatic Side) | Baseline | 71.824 degrees | Standard Deviation 20.467 |
| Slider Group | Hip Flexion Range of Motion (Asymptomatic Side) | After 5th Day | 74.12 degrees | Standard Deviation 18.721 |
| Slider Group | Hip Flexion Range of Motion (Asymptomatic Side) | After 1st Day | 70.82 degrees | Standard Deviation 20.944 |
| Tensioner Group | Hip Flexion Range of Motion (Asymptomatic Side) | After 12th Day | 72.47 degrees | Standard Deviation 10.869 |
| Tensioner Group | Hip Flexion Range of Motion (Asymptomatic Side) | After 1st Day | 69.12 degrees | Standard Deviation 13.114 |
| Tensioner Group | Hip Flexion Range of Motion (Asymptomatic Side) | After 5th Day | 72.12 degrees | Standard Deviation 11.033 |
| Tensioner Group | Hip Flexion Range of Motion (Asymptomatic Side) | Baseline | 63.59 degrees | Standard Deviation 15.407 |
Primary
Hip Flexion Range of Motion (Symptomatic Side)
Change in Hip flexion range of motion during straight leg raising (symptomatic side)
Time frame: The measurements were taken at days 0,1,5,12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Hip Flexion Range of Motion (Symptomatic Side) | Baseline | 51.82 degrees | Standard Deviation 15.314 |
| Control Group | Hip Flexion Range of Motion (Symptomatic Side) | After 1st Day | 58.53 degrees | Standard Deviation 13.884 |
| Control Group | Hip Flexion Range of Motion (Symptomatic Side) | After 5th Day | 59.24 degrees | Standard Deviation 14.338 |
| Control Group | Hip Flexion Range of Motion (Symptomatic Side) | After 12th Day | 57.71 degrees | Standard Deviation 17.944 |
| Slider Group | Hip Flexion Range of Motion (Symptomatic Side) | After 12th Day | 74.41 degrees | Standard Deviation 22.327 |
| Slider Group | Hip Flexion Range of Motion (Symptomatic Side) | Baseline | 57.71 degrees | Standard Deviation 16.042 |
| Slider Group | Hip Flexion Range of Motion (Symptomatic Side) | After 5th Day | 67.47 degrees | Standard Deviation 15.412 |
| Slider Group | Hip Flexion Range of Motion (Symptomatic Side) | After 1st Day | 63.59 degrees | Standard Deviation 15.452 |
| Tensioner Group | Hip Flexion Range of Motion (Symptomatic Side) | After 12th Day | 68.59 degrees | Standard Deviation 12.555 |
| Tensioner Group | Hip Flexion Range of Motion (Symptomatic Side) | After 1st Day | 58.88 degrees | Standard Deviation 16.714 |
| Tensioner Group | Hip Flexion Range of Motion (Symptomatic Side) | After 5th Day | 62.82 degrees | Standard Deviation 13.956 |
| Tensioner Group | Hip Flexion Range of Motion (Symptomatic Side) | Baseline | 46.29 degrees | Standard Deviation 16.243 |
Primary
Knee Flexion Range of Motion (Asymptomatic Side)
Change in Knee flexion range of motion during slump (Asymptomatic side)
Time frame: The measurements were taken at days 0,1,5,12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Knee Flexion Range of Motion (Asymptomatic Side) | Baseline | 31.1176 degrees | Standard Deviation 19.70052 |
| Control Group | Knee Flexion Range of Motion (Asymptomatic Side) | After 1st Day | 30.41 degrees | Standard Deviation 22.319 |
| Control Group | Knee Flexion Range of Motion (Asymptomatic Side) | After 5th Day | 28.94 degrees | Standard Deviation 18.216 |
| Control Group | Knee Flexion Range of Motion (Asymptomatic Side) | After 12th Day | 24.88 degrees | Standard Deviation 17.517 |
| Slider Group | Knee Flexion Range of Motion (Asymptomatic Side) | After 12th Day | 22.29 degrees | Standard Deviation 16.669 |
| Slider Group | Knee Flexion Range of Motion (Asymptomatic Side) | Baseline | 31.7059 degrees | Standard Deviation 12.01439 |
| Slider Group | Knee Flexion Range of Motion (Asymptomatic Side) | After 5th Day | 28.76 degrees | Standard Deviation 19.25 |
| Slider Group | Knee Flexion Range of Motion (Asymptomatic Side) | After 1st Day | 24.06 degrees | Standard Deviation 13.831 |
| Tensioner Group | Knee Flexion Range of Motion (Asymptomatic Side) | After 12th Day | 20.35 degrees | Standard Deviation 12.639 |
| Tensioner Group | Knee Flexion Range of Motion (Asymptomatic Side) | After 1st Day | 26.06 degrees | Standard Deviation 14.528 |
| Tensioner Group | Knee Flexion Range of Motion (Asymptomatic Side) | After 5th Day | 23.88 degrees | Standard Deviation 13.453 |
| Tensioner Group | Knee Flexion Range of Motion (Asymptomatic Side) | Baseline | 28.8824 degrees | Standard Deviation 18.01001 |
Primary
Knee Flexion Range of Motion (Symptomatic Side)
Change in Knee flexion range of motion during slump (symptomatic side)
Time frame: The measurements were taken at days 0,1,5,12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Knee Flexion Range of Motion (Symptomatic Side) | Baseline | 52.29 degrees | Standard Deviation 17.395 |
| Control Group | Knee Flexion Range of Motion (Symptomatic Side) | After 1st Day | 49.41 degrees | Standard Deviation 17.603 |
| Control Group | Knee Flexion Range of Motion (Symptomatic Side) | After 5th Day | 48 degrees | Standard Deviation 14.018 |
| Control Group | Knee Flexion Range of Motion (Symptomatic Side) | After 12th Day | 47 degrees | Standard Deviation 16.733 |
| Slider Group | Knee Flexion Range of Motion (Symptomatic Side) | After 12th Day | 26.882 degrees | Standard Deviation 15.419 |
| Slider Group | Knee Flexion Range of Motion (Symptomatic Side) | Baseline | 45.647 degrees | Standard Deviation 18.435 |
| Slider Group | Knee Flexion Range of Motion (Symptomatic Side) | After 5th Day | 31.412 degrees | Standard Deviation 14.59 |
| Slider Group | Knee Flexion Range of Motion (Symptomatic Side) | After 1st Day | 31.294 degrees | Standard Deviation 12.133 |
| Tensioner Group | Knee Flexion Range of Motion (Symptomatic Side) | After 12th Day | 64.47 degrees | Standard Deviation 25.529 |
| Tensioner Group | Knee Flexion Range of Motion (Symptomatic Side) | After 1st Day | 34.824 degrees | Standard Deviation 15.509 |
| Tensioner Group | Knee Flexion Range of Motion (Symptomatic Side) | After 5th Day | 31.765 degrees | Standard Deviation 14.342 |
| Tensioner Group | Knee Flexion Range of Motion (Symptomatic Side) | Baseline | 47.059 degrees | Standard Deviation 14.545 |
Primary
Visual Analog Scale
Visual analog scale was used to measure pain intensity. This scale is a 10 cm line where patients chose from 0 to 10 (when 0 mean no pain and 10 mean maximum pain)
Time frame: The measurements were taken at days 0,1,5,12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Visual Analog Scale | Basline | 5.638 Centimeters | Standard Deviation 1.75762 |
| Control Group | Visual Analog Scale | After 1st Day | 4.894 Centimeters | Standard Deviation 1.86001 |
| Control Group | Visual Analog Scale | After 5th Day | 5.100 Centimeters | Standard Deviation 1.87508 |
| Control Group | Visual Analog Scale | After 12th Day | 4.665 Centimeters | Standard Deviation 1.74676 |
| Slider Group | Visual Analog Scale | After 12th Day | 2.626 Centimeters | Standard Deviation 2.23538 |
| Slider Group | Visual Analog Scale | Basline | 5.050 Centimeters | Standard Deviation 2.15029 |
| Slider Group | Visual Analog Scale | After 5th Day | 3.556 Centimeters | Standard Deviation 2.21613 |
| Slider Group | Visual Analog Scale | After 1st Day | 4.759 Centimeters | Standard Deviation 1.99125 |
| Tensioner Group | Visual Analog Scale | After 12th Day | 2.082 Centimeters | Standard Deviation 1.56734 |
| Tensioner Group | Visual Analog Scale | After 1st Day | 3.576 Centimeters | Standard Deviation 2.2281 |
| Tensioner Group | Visual Analog Scale | After 5th Day | 2.606 Centimeters | Standard Deviation 2.02005 |
| Tensioner Group | Visual Analog Scale | Basline | 5.094 Centimeters | Standard Deviation 1.95015 |