NCT03621878

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 22, 2019

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

2.4 years

First QC Date

July 30, 2018

Results QC Date

January 23, 2019

Last Update Submit

February 28, 2023

Conditions

Keywords

Lumbosacral radiculopathyperipheral sensitizationNeural mobilizationradicular LBPslidertensioner

Outcome Measures

Primary Outcomes (5)

  • 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"

Study Arms (3)

Control group

ACTIVE COMPARATOR

Patients in this group had 6 sessions in 2 weeks of Transcutaneous Electric Nerve Stimulation (TENS).

Other: Transcutaneous Electrical Nerve Stimulation (TENS)

Tensioner Group

EXPERIMENTAL

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

Slider Group

EXPERIMENTAL

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

Interventions

Exercise aiming to lengthen the neural structure using more than one joint.

Tensioner Group

Exercise aiming to slide/glide the neural structure using more than one joint.

Slider Group

Electrotherapy device aiming to decrease patient's symptoms.

Also known as: Control
Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Radiculopathy

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Results Point of Contact

Title
Mohammed Alghamdi
Organization
imam abdulrahman bin faisal university

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 9, 2018

Study Start

July 1, 2015

Primary Completion

November 28, 2017

Study Completion

March 30, 2018

Last Updated

March 1, 2023

Results First Posted

July 22, 2019

Record last verified: 2023-02