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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Patients in this group had 6 sessions in 2 weeks of Transcutaneous Electric Nerve Stimulation (TENS). |
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| Tensioner Group | Experimental | Patients in this group had 6 sessions in 2 weeks of TENS combined with neural mobilization exercises (Tensioner technique). |
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| Slider Group | Experimental | Patients in this group had 6 sessions in 2 weeks of TENS combined with neural mobilization exercises (Slider technique). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neural mobilization exercises -Tensioner technique | Other | Exercise aiming to lengthen the neural structure using more than one joint. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | The measurements were taken at days "0,1,5,12" |
| Hip Flexion Range of Motion (Symptomatic Side) | Change in Hip flexion range of motion during straight leg raising (symptomatic side) | The measurements were taken at days "0,1,5,12" |
| Knee Flexion Range of Motion (Symptomatic Side) | Change in Knee flexion range of motion during slump (symptomatic side) | The measurements were taken at days "0,1,5,12" |
| Hip Flexion Range of Motion (Asymptomatic Side) | Change in Hip Flexion Range of Motion During Straight Leg Raising (Asymptomatic Side) | The measurements were taken at days "0,1,5,12" |
| Knee Flexion Range of Motion (Asymptomatic Side) | Change in Knee flexion range of motion during slump (Asymptomatic side) | The measurements were taken at days "0,1,5,12" |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Tensioner Group |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2019 |
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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.
| Neural mobilization exercises -Slider technique | Other | Exercise aiming to slide/glide the neural structure using more than one joint. |
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| Transcutaneous Electrical Nerve Stimulation (TENS) | Other | Electrotherapy device aiming to decrease patient's symptoms. |
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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 |
| FG002 | 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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| body mass insex | Median | Standard Deviation | Kg/m^2 |
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| Pain | visual analog scale was used to measure pain intensity in the baseline measurement. this scale is a 10 cm line where patients chose from 0 to 10 (when 0 mean no pain and 10 mean maximum pain) | Mean | Standard Deviation | Centimeters |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | Centimeters | The measurements were taken at days "0,1,5,12" |
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| Primary | Hip Flexion Range of Motion (Symptomatic Side) | Change in Hip flexion range of motion during straight leg raising (symptomatic side) | Posted | Mean | Standard Deviation | degrees | The measurements were taken at days "0,1,5,12" |
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| Primary | Knee Flexion Range of Motion (Symptomatic Side) | Change in Knee flexion range of motion during slump (symptomatic side) | Posted | Mean | Standard Deviation | degrees | The measurements were taken at days "0,1,5,12" |
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| Primary | Hip Flexion Range of Motion (Asymptomatic Side) | Change in Hip Flexion Range of Motion During Straight Leg Raising (Asymptomatic Side) | Posted | Mean | Standard Deviation | degrees | The measurements were taken at days "0,1,5,12" |
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| Primary | Knee Flexion Range of Motion (Asymptomatic Side) | Change in Knee flexion range of motion during slump (Asymptomatic side) | Posted | Mean | Standard Deviation | degrees | The measurements were taken at days "0,1,5,12" |
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data was collected in around 3 years
no participants was in risk of mortality or Serious Adverse Events because the participants in this study ware patients with mild low back pain and and all the treatment we used ware gentle and without any serious adverse effects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 17 | 0 | 17 | 0 | 17 |
| EG001 | 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 | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | 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 | 0 | 17 | 0 | 17 | 0 | 17 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohammed Alghamdi | imam abdulrahman bin faisal university | +966556852888 | mohdg.ios@gmail.com |
| May 19, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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| After 5th Day |
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| After 12th Day |
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