Effect of Neural Mobilization on Lumbosacral Radiculopathy Patients With Peripheral Sensitization

• Sponsor: Mohammed Al-Ghamdi (Other)
• Overall Status: Completed
• CT.gov ID: NCT03621878
• Collaborator: (none)
• Enrollment: 51
• Arms: 3
• Actual Duration (Months): 33

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Radiculopathy	Other: Neural mobilization exercises -Tensioner technique; Other: Neural mobilization exercises -Slider technique; Other: Transcutaneous Electrical Nerve Stimulation (TENS)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, 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.
• Primary Purpose: Treatment
• Official Title: Effect of Neural Mobilization Techniques on Pain, and Hip and Knee Range of Motion on Lumbosacral Radiculopathy Patients With Peripheral Sensitization
• Actual Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Nov 28, 2017
• Actual Study Completion Date: Mar 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group Patients in this group had 6 sessions in 2 weeks of Transcutaneous Electric Nerve Stimulation (TENS).	Other: Transcutaneous Electrical Nerve Stimulation (TENS); Electrotherapy device aiming to decrease patient's symptoms.; Other Names: Control
Experimental: Tensioner Group Patients in this group had 6 sessions in 2 weeks of TENS combined with neural mobilization exercises (Tensioner technique).	Other: Neural mobilization exercises -Tensioner technique; Exercise aiming to lengthen the neural structure using more than one joint.
Experimental: Slider Group Patients in this group had 6 sessions in 2 weeks of TENS combined with neural mobilization exercises (Slider technique).	Other: Neural mobilization exercises -Slider technique; Exercise aiming to slide/glide the neural structure using more than one joint.

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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)

3. 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)

4. 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)

5. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mohammed Al-Ghamdi

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 17, 2019

More Information

Publications

None provided.

• Responsible Party: Mohammed Al-Ghamdi, Physical Therapist, Imam Abdulrahman Bin Faisal University
• ClinicalTrials.gov Identifier: NCT03621878
• Other Study ID Numbers: IRB-2014-04-321
• First Posted: Aug 9, 2018
• Last Update Posted: Jul 22, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohammed Al-Ghamdi, Physical Therapist, Imam Abdulrahman Bin Faisal University: Lumbosacral radiculopathy; peripheral sensitization; Neural mobilization; radicular LBP; slider; tensioner
• Additional relevant MeSH terms: Radiculopathy

Study Results

Participant Flow

Arm/Group Title	Control Group	Tensioner Group	Slider Group
Arm/Group Description	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	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	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
Period Title: Overall Study
STARTED	17	17	17
COMPLETED	17	17	17
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Control Group	Tensioner Group	Slider Group	Total
Arm/Group Description	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	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	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	Total of all reporting groups
Overall Participants	17	17	17	51
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.24 (9.49)	33.53 (8.64)	36.82 (8.01)	36.86 (8.99)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%
Male	17 100%	17 100%	17 100%	51 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
body mass insex (Kg/m^2) [Median (Standard Deviation) ]
Median (Standard Deviation) [Kg/m^2]	27.08 (3.83)	28.23 (6.04)	28.19 (5.60)	27.83 (5.16)
Pain (Centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Centimeters]	5.63 (1.75)	5.09 (1.95)	5.05 (2.15)	5.26 (1.93)

Outcome Measures

1. Primary Outcome

Title	Visual Analog Scale
Description	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"

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Slider Group	Tensioner Group
Arm/Group Description	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	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	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
Measure Participants	17	17	17
Basline	5.638 (1.75762)	5.050 (2.15029)	5.094 (1.95015)
After 1st Day	4.894 (1.86001)	4.759 (1.99125)	3.576 (2.22810)
After 5th Day	5.100 (1.87508)	3.556 (2.21613)	2.606 (2.02005)
After 12th Day	4.665 (1.74676)	2.626 (2.23538)	2.082 (1.56734)

2. Primary Outcome

Title	Hip Flexion Range of Motion (Symptomatic Side)
Description	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"

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Slider Group	Tensioner Group
Arm/Group Description	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	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	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
Measure Participants	17	17	17
Baseline	51.82 (15.314)	57.71 (16.042)	46.29 (16.243)
After 1st Day	58.53 (13.884)	63.59 (15.452)	58.88 (16.714)
After 5th Day	59.24 (14.338)	67.47 (15.412)	62.82 (13.956)
After 12th Day	57.71 (17.944)	74.41 (22.327)	68.59 (12.555)

3. Primary Outcome

Title	Knee Flexion Range of Motion (Symptomatic Side)
Description	Change in Knee flexion range of motion during slump (symptomatic side)
Time Frame	The measurements were taken at days "0,1,5,12"

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Slider Group	Tensioner Group
Arm/Group Description	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	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	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
Measure Participants	17	17	17
Baseline	52.29 (17.395)	45.647 (18.435)	47.059 (14.545)
After 1st Day	49.41 (17.603)	31.294 (12.133)	34.824 (15.509)
After 5th Day	48 (14.018)	31.412 (14.590)	31.765 (14.342)
After 12th Day	47 (16.733)	26.882 (15.419)	64.47 (25.529)

4. Primary Outcome

Title	Hip Flexion Range of Motion (Asymptomatic Side)
Description	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"

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Slider Group	Tensioner Group
Arm/Group Description	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	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	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
Measure Participants	17	17	17
Baseline	70.00 (15.313)	71.824 (20.467)	63.59 (15.407)
After 1st Day	69.41 (17.044)	70.82 (20.944)	69.12 (13.114)
After 5th Day	71.12 (11.146)	74.12 (18.721)	72.12 (11.033)
After 12th Day	73.06 (12.920)	74.88 (19.251)	72.47 (10.869)

5. Primary Outcome

Title	Knee Flexion Range of Motion (Asymptomatic Side)
Description	Change in Knee flexion range of motion during slump (Asymptomatic side)
Time Frame	The measurements were taken at days "0,1,5,12"

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Slider Group	Tensioner Group
Arm/Group Description	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	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	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
Measure Participants	17	17	17
Baseline	31.1176 (19.70052)	31.7059 (12.01439)	28.8824 (18.01001)
After 1st Day	30.41 (22.319)	24.06 (13.831)	26.06 (14.528)
After 5th Day	28.94 (18.216)	28.76 (19.250)	23.88 (13.453)
After 12th Day	24.88 (17.517)	22.29 (16.669)	20.35 (12.639)

Adverse Events

Time Frame	data was collected in around 3 years
Adverse Event Reporting Description	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.
Arm/Group Title	Control Group		Tensioner Group		Slider Group
Arm/Group Description	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		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		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
All Cause Mortality
	Control Group		Tensioner Group		Slider Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)		0/17 (0%)
Serious Adverse Events
	Control Group		Tensioner Group		Slider Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		Tensioner Group		Slider Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.